JP2020156921A - Syringe - Google Patents

Abstract

To provide a syringe capable of reducing a slide resistance and suppressing occurrence of pulse in use of a syringe pump.SOLUTION: A syringe comprises: a barrel 120 comprising a cylindrical trunk 121 for including a chemical and a nozzle part 122 being provided on a tip end part of the trunk 121 for discharging the chemical, and comprising on a base end part of the trunk 121, a base end opening part 124; a gasket 140 which slides on an inner face of the trunk 121 of the barrel 120; a syringe pusher 150 which can be fitted to the gasket 140; and a silicon oil for coating the inner surface of the trunk 121 of the barrel 120. On the inner surface of the trunk 121 of the barrel 120, a recess in which the silicon oil can be stored is formed, and an average surface roughness of the inner face is 0.05 to 0.50 μm in the syringe.SELECTED DRAWING: Figure 1

Description

The present disclosure relates to syringes.

Syringes are used in the medical field to deliver chemicals into the patient's body. By pressing the syringe pusher, the user slides the inner surface of the barrel on the gasket to send the chemical solution. Here, if the sliding resistance is large, the user needs to press the syringe pusher with a large pressure, which may reduce usability. Further, if the sliding resistance is large, when the syringe pump is used to feed the liquid, the syringe pump may erroneously detect that the blockage has occurred and stop the liquid feeding, so that the drug solution may not be administered to the patient. Further, the sliding resistance increases even when the viscosity of the chemical solution is high.

Patent Document 1 discloses a technique for reducing sliding resistance by forming irregularities on the inner surface of a barrel. Further, Patent Document 2 discloses a technique for reducing sliding resistance by coating the inner surface of the barrel with silicone oil.

U.S. Patent Application Publication No. 2017/03408825 Japanese Patent No. 5517950

For the syringes described in Patent Documents 1 and 2, the amount of the chemical solution to be sent per unit time (hereinafter, also simply referred to as “flow rate”) is set by using a syringe pump. In such a case, even with the syringes described in Patent Documents 1 and 2, pulsation may occur depending on the set flow rate.

An object of the present disclosure is to provide a syringe capable of suppressing the occurrence of pulsation when using a syringe pump while reducing sliding resistance.

The syringe as the first aspect of the present invention has a tubular body portion containing the chemical solution and a nozzle portion provided on the tip end side of the body portion to discharge the chemical solution, and also has a base end portion of the body portion. A barrel provided with an opening at the base end, a gasket that slides on the inner surface of the body of the barrel, a syringe pusher that can be attached to the gasket, and silicone that covers the inner surface of the body of the barrel. The inner surface of the body of the barrel is provided with oil, and a recess in which the silicone oil can stay is formed, and the average surface roughness of the inner surface is 0.05 to 0.50 μm.

As one embodiment of the present invention, the average surface roughness of the inner surface is preferably 0.05 to 0.30 μm.

As one embodiment of the present invention, it is preferable that the recess of the barrel is a groove extending in the axial direction of the barrel.

As one embodiment of the present invention, the gasket preferably has a peak portion that extends in the circumferential direction and slides on the inner surface of the body portion of the barrel.

In one embodiment of the present invention, it is preferable that the gasket slides on the inner surface of the body of the barrel so that the silicone oil stays in the recess of the barrel.

As one embodiment of the present invention, the concave portion of the barrel is used as the first concave portion, and the convex portion located between the two adjacent first concave portions has a second recess that is shallower than the first concave portion. It is preferable that a recess is formed.

According to the present disclosure, it is possible to provide a syringe capable of suppressing the occurrence of pulsation when using a syringe pump while reducing sliding resistance.

It is a figure which shows the syringe as one Embodiment. It is an enlarged cross-sectional view of a part of the cross section passing through the axis of the syringe 100 of FIG. It is a figure which shows how the silicone oil 160 stays in the recess 121g1 of a barrel 120 in the syringe of FIG. It is a partially developed view of the inner surface 121i of the body portion 121 of the barrel 120 in the modification. It is a cross-sectional view which expanded a part of the cross section along the line I-I of FIG. It is an enlarged view which shows a part of the inner surface 121i of the body part 121 of the barrel 120 in the modification.

Hereinafter, embodiments of the syringe according to the present disclosure will be described with reference to the drawings. The same reference numerals are given to common members and parts in each figure.

FIG. 1 is a diagram showing a syringe 100 as an embodiment of the syringe according to the present disclosure. FIG. 2 is an enlarged cross-sectional view showing a part of the cross section passing through the axis of the syringe 100 of FIG.

As shown in FIG. 1, the syringe 100 of the present embodiment includes a chemical solution 110, a barrel 120, a cap 130, a gasket 140, and a syringe pusher 150. Further, as shown in FIG. 2, the syringe 100 includes a silicone oil 160 that covers the inner surface 121i of the body portion 121 of the barrel 120.

The drug solution 110 is, for example, an anticancer agent, an anesthetic agent, a chemotherapeutic agent, a blood transfusion, or a nutritional agent. The drug solution 110 is injected into the patient's body. FIG. 1 shows a state in which the chemical solution 110 is contained in the barrel 120. The chemical solution 110 may be filled in the barrel 120, for example, immediately before the liquid delivery.

The barrel 120 has a body portion 121, a nozzle portion 122, and a flange portion 123. Further, the barrel 120 is provided with a base end opening 124.

The body portion 121 has a tubular shape (for example, a cylindrical shape) and contains a chemical solution 110.

As shown in FIG. 2, a recess 121g is formed on the inner surface 121i of the body portion 121 of the barrel 120. Details of the recess 121g will be described later.

As shown in FIG. 1, the nozzle portion 122 is provided on the tip end side of the body portion 121. A tip opening 122o is provided at the tip of the nozzle portion 122. The chemical solution 110 is discharged from the tip opening 122o. The nozzle portion 122 has a cylindrical shape, and a tube 170 (indicated by a two-dot chain line in FIG. 1) can be connected to the nozzle portion 122.

The flange portion 123 projects from the base end portion of the body portion 121 toward the outside in the radial direction of the body portion 121.

The base end opening 124 is provided at the base end portion of the body portion 121. The syringe pusher 150 is inserted through the proximal opening 124.

The cap 130 can seal the tip opening 122o provided at the tip of the nozzle portion 122. FIG. 1 shows a state in which the cap 130 is removed from the nozzle portion 122 and the tip opening portion 122o is opened.

In the present embodiment, the gasket 140 is made of rubber or elastomer, and its surface is coated with a fluororesin such as Teflon (registered trademark) or parylene (registered trademark). As shown in FIG. 2, the gasket 140 is slidable with the inner surface 121i of the body portion 121.

As shown in FIG. 2, the gasket 140 has a columnar main body portion 143, a first peak portion 141 projecting radially outward on one end side of the main body portion 143, and the other end side of the main body portion 143. The second peak portion 142 is provided so as to project outward in the radial direction.

The first peak portion 141 and the second peak portion 142 are annular protrusions extending in the circumferential direction of the gasket 140. Therefore, the maximum outer diameters of the first peak portion 141 and the second peak portion 142 are larger than the outer diameter of the main body portion 143. The maximum outer diameter of the first peak portion 141 is substantially equal to the maximum outer diameter of the second peak portion 142.

The first peak portion 141 and the second peak portion 142 slide with the inner surface 121i of the body portion 121 of the barrel 120. Further, the first peak portion 141 seals between the chemical solution 110 and the inner surface 121i so that the chemical solution 110 does not leak to the proximal end side of the first peak portion 141. In other words, the portion of the barrel 120 on the tip end side with respect to the first peak portion 141 of the gasket 140 becomes the chemical liquid storage portion in which the chemical liquid 110 is stored. The second peak portion 142 is sealed between the second peak portion 142 and the inner surface 121i so that water vapor does not enter from the proximal end side of the second peak portion 142.

As shown in FIG. 1, the syringe pusher 150 can be attached to the gasket 140. In the present embodiment, the syringe pusher 150 includes a mounting member 151 that can be mounted on the gasket 140 and a pressing member 152 that can be mounted on the base end side of the mounting member 151.

The pressing member 152 is movable in the axial direction A of the body portion 121. The pressing member 152 includes a main body portion 152a and a flange portion 152b.

The tip of the main body 152a can be fixed to the mounting member 151. The pressing member 152 and the mounting member 151 can be fixed, for example, by screw joining. At the time of shipment of the syringe 100, the mounting member 151 fixed to the gasket 140 in the barrel 120 and the pressing member 152 can be separated. Since the pressing member 152 is generally a long member, the syringe 100 is shipped with the mounting member 151 and the pressing member 152 separated, so that the total length in the axial direction is shortened as compared with the non-separated state. The syringe 100 can be transported. The user can fix the pressing member 152 to the mounting member 151 fixed to the gasket 140 in the barrel 120 at the site.

The flange portion 152b is a base end portion of the pressing member 152 and projects outward from the main body portion 152a in the radial direction.

With reference to FIG. 2, the syringe 100 includes silicone oil 160 that covers the inner surface 121i of the body 121 of the barrel 120. The silicone oil 160 lubricates between the gasket 140 and the inner surface 121i of the body portion 121 of the barrel 120, so that the sliding resistance between the gasket 140 and the inner surface 121i can be reduced. In this embodiment, the silicone oil 160 is a silicone oil that meets medical grade.

A recess 121g on which the silicone oil 160 can stay is formed on the inner surface 121i of the body portion 121 of the barrel 120. In the present embodiment, the recess 121g is a groove extending along the circumferential direction of the barrel 120.

In manufacturing the syringe 100 of the present embodiment, the silicone oil 160 is applied or sprayed on the inner surface 121i of the body portion 121, and then the gasket 140 is inserted into the barrel 120. As shown in FIG. 2, silicone oil 160 is retained in the recess 121g. Further, as shown in FIG. 2, the gasket 140 removes excess silicone oil 160 that cannot be completely retained in the recess 121g by pushing it toward the tip side.

Silicone oil 160 is retained in the recess 121g shown in FIG. 2 regardless of the passage of the gasket 140, but the configuration is not limited to this. In FIG. 3, unlike FIG. 2, the silicone oil 160 does not stay in the recess 121g0 before the gasket 140 passes through. In such a case, when the gasket 140 is slid toward the tip as shown by the arrow in FIG. 3, the silicone oil 160 enters and stays in the recess 121g1 after the gasket 140 has passed. In this way, the gasket 140 may slide with the inner surface 121i of the body portion 121 of the barrel 120 to retain the silicone oil 160 in the recess 121g1.

Further, as shown in FIG. 2, in the present embodiment, the recess 121g extends from the tip end side to the proximal end side of the inner surface 121i of the body portion 121 of the barrel 120, but the recessed portion 121g extends from the body portion of the barrel 120, for example. It can also be provided only near the tip of 121.

In FIG. 2, the recess 121g is a groove extending along the circumferential direction of the barrel 120, but the shape of the recess 121g is not particularly limited, such as the extending direction of the groove. The recess 121g may be, for example, a groove extending inclined with respect to the circumferential direction of the barrel 120. Further, the recess 121g may be, for example, a spiral groove extending from the tip end side to the base end side of the inner surface 121i. Further, the recess 121g may be a groove extending along the axial direction A of the barrel 120, as will be described later (see FIG. 4). Further, the above-mentioned various grooves as the recess 121g may be combined. However, if grooves having various extending directions are mixed, the transparency of the barrel 120 may be lowered, and the chemical solution 110 (see FIG. 1) in the body portion 121 may be difficult to see. Therefore, it is preferable that the extending direction of the groove as the recess 121g is substantially the same direction.

FIG. 4 shows a part of a developed view of the inner surface 121i of the body portion 121 of the barrel 120 as a modification. FIG. 5 is a cross-sectional view taken along the line I-I of FIG. The recess 121g shown in FIG. 4 is a groove extending along the axial direction A of the barrel 120. The depths of the grooves on the inner surface 121i as the recesses 121g are almost the same. Further, the length and width of the groove as the recess 121g is the length and width that the silicone oil 160 can enter and stay. Further, the groove as the recess 121g is preferably configured to have a size so that the gasket 140 does not enter when sliding with the inner surface 121i. As an example, as shown in FIG. 4, the extending direction of the groove as the recess 121g is different from the extending direction of the first peak portion 141 and the second peak portion 142 (see FIG. 2) of the gasket 140. By doing so, it may be difficult for the gasket 140 to enter the groove when sliding with the inner surface 121i. That is, as shown in FIG. 4, the groove as the recess 121g extends along the axial direction A of the barrel 120, and as shown in FIG. 2, the first peak portion 141 and the second peak portion 142 of the gasket 140 are barreled. It can be extended in the circumferential direction of 120.

The recess 121g of the inner surface 121i of the body portion 121 of the barrel 120 can be formed by grinding the inner surface 121i with, for example, a file. Further, the recess 121g may be formed by injection molding by providing the mold with irregularities.

In particular, as shown in FIG. 4, by extending the groove as the recess 121 g along the axial direction A of the barrel 120, when the mold is pulled out from the injection-molded barrel 120 in the axial direction A, the mold and the mold are formed. Damage to the barrel 120 due to sliding of the barrel 120 can be suppressed. As described above, considering the application of injection molding, it is particularly preferable that the groove as the recess 121g extends along the axial direction A.

FIG. 6 is a diagram showing an inner surface 121i2 as a further modification of the inner surface 121i of the barrel 120. Similar to FIG. 4, a first recess 121g is formed on the inner surface 121i2. Further, a second recess 121g2 shallower than the first recess 121g is formed in the convex portion located between the two adjacent first recesses 121g.

Such a first recess 121g and a second recess 121g2 can be formed by grinding the inner surface 121i2 of the barrel 120 with a coarse file and then grinding with a fine file or the like. Further, similarly to the inner surface 121i of FIG. 4, when the barrel 120 is injection-molded, the mold is provided with irregularities and the irregularities are transferred to the barrel 120 to form a groove as a first recess 121g and a second recess. A groove as 121 g2 may be formed.

The average roughness of the inner surface 121i of the body portion 121 is 0.05 to 0.50 μm. As a result, it is possible to suppress the occurrence of pulsation when using the syringe pump while reducing the sliding resistance. The average roughness is more preferably 0.05 to 0.30 μm. The average roughness (Ra) referred to in the present specification refers to an arithmetic mean roughness. The arithmetic mean roughness is defined by extracting only the reference length 1.25 mm (L) in the direction of the average line from the roughness curve within a range of 20 mm from the tip of the gasket 140 to the tip side of the body 121, and this extracted portion. It means the value obtained by the following formula when the x-axis is taken in the direction of the average line and the y-axis is taken in the direction of the vertical magnification and expressed by the roughness curve y = f (x).

The outline and results of the tests conducted on the syringe to demonstrate the presence or absence of sliding resistance and pulsation will be described below.

First, the syringes of Examples 1 to 9 and Comparative Examples 1 to 4 prepared for the test will be described. The barrel of the syringe is made of polypropylene. The nominal volume of the chemical solution that can be stored in the barrel is 50 ml.

The inner surface of the barrel of the syringe was polished with an abrasive. The particle sizes of the abrasives used are # 400, # 600, # 800, # 1000, # 4000 and # 10000, respectively. As shown in Table 1 described later, the syringes of Examples 6 and 9 and Comparative Examples 1 and 3 to 4 were polished using only one particle size abrasive. Other syringes were polished with a certain particle size abrasive and then with another particle size abrasive. Table 1 shows the surface roughness Ra of the inner surface of each syringe after polishing. The surface roughness Ra of the inner surface of the barrel of the unpolished syringe was 0.032.

As shown in Table 1 described later, a syringe in which the inner surface of the barrel was coated with silicone oil was prepared. We also prepared a syringe in which the inner surface of the barrel was not coated with silicone oil.

After filling the syringe with the drug solution, it was attached to the autograph. Then, the gasket of the syringe was slid at a speed of 4 mm / min by an autograph, and the sliding resistance between the gasket and the syringe was measured at that time. In addition, the presence or absence of pulsation was confirmed from the obtained sliding resistance chart.

Table 1 below shows the measurement results of the presence or absence of sliding resistance and pulsation of the syringes of Examples 1 to 9 and Comparative Examples 1 to 4.

Regarding the items of sliding resistance in Table 1, "◎" indicates that the sliding resistance is 70% of the sliding resistance of a syringe (hereinafter, also referred to as "reference example") that has not been polished and is coated with silicone oil. Indicates less than. “◯” indicates that the sliding resistance is 70 to 110% of the sliding resistance of the reference example. “X” indicates that the sliding resistance is more than 110% of the sliding resistance of the reference example.

Regarding the pulsation items in Table 1, "○" indicates that the occurrence of pulsation during sliding was suppressed compared to the reference example, and "x" indicates that the same pulsation as in the reference example occurred. Is shown. In the above-mentioned reference example, pulsation occurred in the range of 50% or more of the sliding distance.

Looking at the items of sliding resistance in Table 1, all syringes whose inner surface of the barrel body is not coated with silicone oil are more slidable than syringes that are not polished and are coated with silicone oil (reference example). It was found that the dynamic resistance was increased. Further, it was found that the sliding resistance of Examples 1 to 6 was about the same as the sliding resistance of the reference example in a state where the inner surface of the body of the barrel was coated with silicone oil. It was also found that the sliding resistances of Examples 7 to 9 and Comparative Example 4 were smaller than those of the reference example.

Looking at the pulsation items in Table 1, in a state where the inner surface of the barrel body is not coated with silicone oil, in Examples 1 to 6, 8 to 9 and Comparative Examples 2 and 4, unpolished silicone was used. It was found that the occurrence of pulsation was suppressed as compared with the syringe coated with oil (reference example). It was also found that in Examples 1 to 9 and Comparative Examples 2 to 3 in a state where the inner surface of the barrel body was coated with silicone oil, the occurrence of pulsation was suppressed as compared with the reference example. ..

From the above, the average surface roughness of the inner surface of the barrel is set to 0.05 to 0.50 μm, and the inner surface of the barrel is coated with silicone oil to reduce the sliding resistance between the gasket and the inner surface of the barrel. It was found that the occurrence of pulsation can be suppressed as compared with the reference example syringe while keeping the sliding resistance of the reference example syringe unpolished and coated with silicone oil to the same level.

Further, it was found that the sliding resistance can be further reduced by setting the average surface roughness of the inner surface of the barrel to 0.05 to 0.30 μm and coating the inner surface of the barrel with silicone oil.

100: Syringe 110: Chemical solution 120: Barrel 121: Body 121 g, 121 g0, 121 g 1: Recess (first recess)
121g2: Second recesses 121i, 121i2: Inner surface 122: Nozzle portion 122o: Tip opening 123: Flange portion 124: Base end opening 130: Cap 140: Gasket 141: First peak portion 142: Second peak portion 143: Main body 150: Syringe pusher 151: Mounting member 152: Pressing member 152a: Main body 152b: Flange 160: Silicone oil 170: Tube A: Axial direction

Claims (6)

A barrel having a tubular body portion containing the chemical solution and a nozzle portion provided on the tip end side of the body portion to discharge the chemical solution and having a base end opening provided at the base end portion of the body portion.
A gasket that slides on the inner surface of the body of the barrel,
A syringe pusher that can be attached to the gasket and
Silicone oil that covers the inner surface of the body of the barrel,
With
A recess in which the silicone oil can stay is formed on the inner surface of the body of the barrel.
A syringe having an average surface roughness of the inner surface of 0.05 to 0.50 μm. The syringe according to claim 2, wherein the average surface roughness of the inner surface is 0.05 to 0.30 μm. The syringe according to claim 1 or 2, wherein the recess of the barrel is a groove extending in the axial direction of the barrel. The syringe according to any one of claims 1 to 3, wherein the gasket has a peak portion extending in the circumferential direction and sliding on the inner surface of the body portion of the barrel. The syringe according to any one of claims 1 to 4, wherein the silicone oil stays in the recess of the barrel as the gasket slides on the inner surface of the body of the barrel. Claim 1 in which the concave portion of the barrel is used as a first concave portion, and a second concave portion shallower than the first concave portion is formed in a convex portion located between two adjacent first concave portions. 5. The syringe according to any one of 5.

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