Vial adapter

Abstract

A vial adapter according to the present disclosure has a spike portion that extends in an elongated manner from the proximal end to the distal end to define the longitudinal direction, and forms a liquid flow path therein. The liquid flow path has a discharge port that opens to the outer peripheral surface of the spike portion in a cross-section orthogonal to the longitudinal direction. The discharge port has, in the cross-section, an enlarged opening portion in which an opening angle defined by two straight lines connecting the central axis of the spike portion and two ends of the discharge port along the circumferential direction around the central axis gradually increases toward the distal end side.

Description

Vial Adapter

[0001] The present disclosure relates to a vial adapter.

[0002] A vial adapter is known which has a spike portion that extends elongately from the base end to the tip end, defining the longitudinal direction, and forms a liquid flow path therein, and the liquid flow path has a discharge port that opens to the outer peripheral surface of the spike portion in a cross section perpendicular to the longitudinal direction (see, for example, Patent Document 1).

[0003] JP 2010-124898 A

[0004] According to the vial adapter described in Patent Document 1, the spike portion can be pierced through a rubber stopper provided at the mouth of a vial, allowing liquid to be injected into the vial through an outlet. However, with the vial adapter described in Patent Document 1, the outlet can be blocked by the inner surface of the fixing portion of the rubber stopper that fits into the mouth of the vial, preventing the liquid from being discharged from the outlet. Furthermore, because the outlet is provided on the outer peripheral surface of the spike portion in a cross section perpendicular to the longitudinal direction of the spike portion, the edge of the outlet can get caught, making it difficult to pierce the rubber stopper with the spike portion.

[0005] An object of the present disclosure is to provide a vial adapter having a spike portion that is less likely to hinder the discharge of liquid from the discharge port and that can easily pierce a rubber stopper.

[0006] A vial adapter according to a first aspect of the present disclosure is a vial adapter comprising: (1) a spike portion that extends elongately from a base end to a tip end, defining a longitudinal direction, and forming a liquid flow path therein; the liquid flow path having an outlet that opens onto the outer peripheral surface of the spike portion in a cross section perpendicular to the longitudinal direction; and the outlet portion having an enlarged opening in the cross section, the opening angle defined by two straight lines connecting the central axis of the spike portion and the two ends of the outlet portion that are circumferentially aligned around the central axis, gradually increasing toward the tip end.

[0007] A vial adapter according to one embodiment of the present disclosure is the vial adapter described in (1) above, wherein the spike portion has a baffle surface that guides the liquid flowing through the liquid flow path from the base end side to the tip end side toward the outlet.

[0008] A vial adapter according to one embodiment of the present disclosure is the vial adapter described in (1) or (2) above, wherein the outlet is connected to the base end side of the enlarged opening and has a base end opening whose opening angle is constant regardless of the position in the longitudinal direction.

[0009] A vial adapter according to one embodiment of the present disclosure is the vial adapter according to any one of (1) to (3) above, wherein: (4) the spike portion has a sharp tip portion consisting of a tapered tip portion; and an outlet forming portion that forms the outlet, located closer to the base end than the sharp tip portion; the outlet forming portion has an outer circumferential surface that conforms to an ellipse in the cross section, and the length of the major axis of the ellipse is constant regardless of the position in the longitudinal direction.

[0010] A vial adapter according to one embodiment of the present disclosure is (5) the vial adapter according to (4) above, wherein the length of the minor axis of the ellipse of the outlet forming portion decreases toward the tip side.

[0011] A vial adapter according to one embodiment of the present disclosure is the vial adapter described in (4) or (5) above, wherein the spike portion has a root portion connected to the base end side of the outlet forming portion, and the minimum thickness of the root portion is the same as or greater than the maximum thickness of the outlet forming portion.

[0012] A vial adapter according to one embodiment of the present disclosure is (7) the vial adapter according to (6) above, wherein the base portion has an outer peripheral surface that is circular in the cross section.

[0013] A vial adapter according to one embodiment of the present disclosure is the vial adapter described in any one of (1) to (7) above, wherein the spike portion has a gas flow path that forms an open end on the outer surface of the spike portion.

[0014] A vial adapter according to one embodiment of the present disclosure is (9) the vial adapter according to (8) above, wherein the open end of the gas flow path is located closer to the tip than the outlet.

[0015] According to the present disclosure, it is possible to provide a vial adapter that is less likely to obstruct the discharge of liquid from the discharge port and has a spike portion that can easily pierce a rubber stopper.

[0016] 1 is an external view showing a vial adapter according to an embodiment of the present disclosure. FIG. 1 is an external view showing an enlarged view of the spike portion of the vial adapter shown in FIG. 1. FIG. 2 is an external view of the spike portion shown in FIG. 2, viewed from a different perspective than that shown in FIG. 2. FIG. 3 is a cross-sectional view taken along line a-a in FIG. 3. FIG. 4 is a cross-sectional view taken along line bb in FIG. 4. FIG. 4 is a cross-sectional view taken along line c-c in FIG. 4. FIG. 5 is a cross-sectional view taken along line dd in FIG. 4. FIG. 5 is a cross-sectional view taken along line ee in FIG. 4. FIG. 6 is a cross-sectional view taken along line gg in FIG. 4. FIG. 7 is an external view showing the vial adapter shown in FIG. 1 connected to a vial. FIG. 7 is a partial cross-sectional external view showing a cross-section of a portion of FIG. 6. FIG. 8 is an enlarged view of portion Z in FIG.

[0017] Hereinafter, an embodiment of a vial adapter according to the present disclosure will be described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals.

[0018] Fig. 1 is an external view showing a vial adapter 1 as one embodiment of a vial adapter according to the present disclosure. Fig. 6 is an external view showing the vial adapter 1 shown in Fig. 1 connected to a vial 5. As shown in Fig. 6, the vial adapter 1 is used when connected to the vial 5. The vial adapter 1 is used, for example, when supplying liquid into the vial 5. The vial adapter 1 is also used, for example, when aspirating liquid from the vial 5.

[0019] FIG. 7 is a cross-sectional external view showing a portion of the vial adapter 1 and vial 5 shown in FIG. 6 . FIG. 8 is an enlarged view of portion Z in FIG. 7 . As shown in FIGS. 7 and 8 , a rubber stopper 15 is attached to the mouth 18 of the vial 5 of this embodiment. The vial 5 of this embodiment is sealed by attaching the rubber stopper 15 to the mouth 18. The rubber stopper 15 of this embodiment has a substantially circular, flat cover portion 15a arranged to cover the mouth 18, and a fixing portion 15b protruding from this cover portion 15a and engaging with the inner circumferential surface of the mouth 18. The vial adapter 1 of this embodiment is connected to the vial 5 by piercing the spike portion 3 through the cover portion 15a of the rubber stopper 15.

[0020] Figure 2 is an enlarged external view of the spike portion 3 of the vial adapter 1 shown in Figure 1. Figure 3 is an external view of the spike portion 3 shown in Figure 2, viewed from a different perspective than that of Figure 2. Figure 4 is a cross-sectional view taken along line aa in Figure 3. Figures 5A to 5F are cross-sectional views taken along lines bb to gg in Figure 4.

[0021] As shown in FIGS. 2 to 4 , the vial adapter 1 has a spike 3 that extends elongatedly from its base end to its tip, defining a longitudinal direction A, and that defines a liquid flow path 2 therein. As shown in FIGS. 2 to 4 , the spike 3 has a sharpened portion 3a formed from a tapered tip. As shown in FIGS. 2 to 4 , the liquid flow path 2 has an outlet 2b that opens onto the outer circumferential surface of the spike 3 in a cross section (hereinafter simply referred to as the "cross section") perpendicular to the longitudinal direction A. The outlet 2b has an expanding opening 2b2 in the cross section, in which the opening angle θ (see FIGS. 5B and 5C ) defined by two straight lines La and Lb connecting the central axis O of the spike 3 and the two ends 7a and 7b of the outlet 2b along the circumferential direction B around the central axis O gradually increases toward the tip side of the spike 3 (hereinafter simply referred to as the "tip side").

[0022] For example, in the cross-sectional view shown in Figure 5B, the opening angle θ1 is defined by two straight lines La1 and Lb1 connecting the central axis O of the spike 3 to the two ends 7a1 and 7b1 of the outlet 2b that extend in the circumferential direction B around the central axis O. In the cross-sectional view shown in Figure 5C, the opening angle θ2 is defined by two straight lines La2 and Lb2 connecting the central axis O of the spike 3 to the two ends 7a2 and 7b2 of the outlet 2b that extend in the circumferential direction B around the central axis O. The opening angle θ2 is greater than the opening angle θ1.

[0023] By providing the outlet 2b with the enlarged opening 2b2, even when the fixed portion 15b of the rubber stopper 15 is in proximity to or in contact with the outlet 2b of the spike portion 3, as shown in FIG. 8, a gap is easily secured between the enlarged opening 2b2 of the outlet 2b and the fixed portion 15b of the rubber stopper 15 in a direction perpendicular to the longitudinal direction A, making the outlet 2b less likely to be blocked. As a result, the discharge of liquid from the outlet 2b is less likely to be obstructed. This effect is not limited to the fixed portion 15b of the rubber stopper 15, and can be achieved even when, for example, the inner circumferential surface of the opening portion 18 of the vial 5 is in proximity to or in contact with the outlet 2b. Furthermore, since the opening angle θ increases toward the distal end (in other words, the opening angle θ decreases toward the proximal end (hereinafter sometimes simply referred to as the "proximal end") of the spike portion 3), the width W1 (see FIG. 2) of the cutout surface 4 forming the proximal end of the outlet 2b can be easily reduced. By reducing the width W1 of the cutout surface 4, the cutout surface 4 is less likely to catch on the rubber stopper 15 when the spike portion 3 is pierced through the rubber stopper 15, making it easier to pierce the spike portion 3 through the rubber stopper 15. Furthermore, by gradually increasing the opening angle θ toward the tip, no steps are formed at the two ends 7a, 7b of the enlarged opening 2b of the outlet 2b along the circumferential direction B about the central axis O, and when the spike portion 3 is pierced through the rubber stopper 15, the two ends 7a, 7b of the enlarged opening 2b of the outlet 2b along the circumferential direction B about the central axis O are less likely to catch on the rubber stopper 15, making it easier to pierce the spike portion 3 through the rubber stopper 15.

[0024] As shown in FIG. 4 , the spike portion 3 includes a baffle surface 6 that guides the liquid flowing through the liquid flow path 2 from the base end toward the tip end in the longitudinal direction A toward the outlet 2b. More specifically, the baffle surface 6 in this embodiment is the surface facing the base end of the spike portion 3, forming the tip end of the liquid flow path 2. According to the above configuration, by hitting the baffle surface 6 with the liquid flowing through the liquid flow path 2 from the base end toward the tip end in the longitudinal direction A, the liquid can be guided in a direction intersecting the longitudinal direction A, i.e., toward the outlet 2. This allows the liquid to be easily discharged from the outlet 2b. This allows the liquid to flow along the sidewall of the vial 5 when supplied to the vial 5, thereby suppressing foaming.

[0025] Although the baffle surface 6 in this embodiment is a plane perpendicular to the longitudinal direction A, the baffle surface 6 does not have to be perpendicular to the longitudinal direction A as long as it faces the base end. That is, in a longitudinal cross section parallel to the longitudinal direction A, including the central axis O of the spike 3 and passing through the outlet 2b, the baffle surface 6 may be an inclined surface that approaches the tip of the spike 3 as it moves from the central axis O toward the outlet 2b, or an inclined surface that approaches the base end of the spike 3 as it moves from the central axis O toward the outlet 2b. However, since the baffle surface 6 is a plane perpendicular to the longitudinal direction A as in this embodiment, it is possible to prevent the liquid from falling without following the sidewall of the vial 5, compared to an inclined surface that approaches the tip of the spike 3 as it moves from the central axis O toward the outlet 2b. Furthermore, it is possible to prevent the liquid from stagnating in the liquid flow path 2, compared to an inclined surface that approaches the base end of the spike 3 as it moves from the central axis O toward the outlet 2b.

[0026] 2 to 4, the outlet 2b of this embodiment has a base opening 2b1 that is continuous with the base end of the expanded opening 2b2 and has a constant opening angle θ regardless of the position in the longitudinal direction A. With the above configuration, it is easier to reduce the length of each of the two ends 7a, 7b of the outlet 2b along the circumferential direction B about the central axis O than when the outlet 2b is entirely composed of expanded openings 2b2. By reducing the length of each of the two ends 7a, 7b of the outlet 2b along the circumferential direction B about the central axis O, the sliding distance between the spike 3 and the rubber stopper 15 can be reduced when the spike 3 is pierced through the rubber stopper 15, making it easier to pierce the spike 3 through the rubber stopper 15.

[0027] As shown in Figures 2 to 4, the spike portion 3 of this embodiment has an outlet-forming portion 3b that forms the outlet 2b and is located closer to the base end than the sharp tip portion 3a. As shown in Figures 5B and 5C, the outer peripheral surface of the outlet-forming portion 3b of this embodiment has a shape that follows an ellipse in cross section, and the length of the major axis of the ellipse is constant regardless of the position in the longitudinal direction A. Also, as shown in Figures 5B and 5C, the outlet 2b of this embodiment opens in the direction of the major axis of the ellipse. In this disclosure, the term "shape that follows an ellipse" includes an ellipse and a shape that is an ellipse when partially completed with an imaginary line.

[0028] According to the above configuration, because the outer peripheral surface of the outlet-forming portion 3b has an elliptical cross-section, the cross-sectional area of ​​the spike portion 3 can be easily reduced, making it easier to pierce the rubber stopper 15 with the spike portion 3, compared to, for example, a case in which the outer peripheral surface of the outlet-forming portion 3b has a circular cross-section. Furthermore, because the length of the major axis of the ellipse is constant regardless of the position in the longitudinal direction A, it is easy to ensure space for arranging the liquid flow path 2 and the gas flow path 11 described below within the spike portion 3. More specifically, as shown in Figures 5B and 5C, by arranging the liquid flow path 2 and the gas flow path 11 side by side on the major axis of the ellipse, it is easy to ensure space for arranging the liquid flow path 2 and the gas flow path 11 within the spike portion 3. Furthermore, when the outlet 2b opens in the longitudinal direction of the major axis of the ellipse as in this embodiment (see Figures 5B and 5C), the length of the major axis of the ellipse is constant regardless of the position in the longitudinal direction A, making it easier to ensure the width W2 of the baffle surface 6 (see Figure 4) than when the length of the major axis of the ellipse decreases toward the tip.

[0029] In the outlet forming portion 3b of this embodiment, the length of the minor axis of the ellipse described above decreases toward the tip (see FIGS. 5B and 5C ). With this configuration, when the liquid flow path 2 and the gas flow path 11 are arranged side by side on the major axis of the ellipse as in this embodiment, the cross-sectional area of ​​the spike portion 3 can be efficiently reduced while ensuring space for arranging the liquid flow path 2 and the gas flow path 11 inside the spike portion 3, making it easier to pierce the spike portion 3 into the rubber stopper 15.

[0030] As shown in Figures 2 to 4, the spike portion 3 has a base portion 3c that connects to the base end of the outlet-forming portion 3b. In this embodiment, the minimum thickness of the base portion 3c is the same as or greater than the maximum thickness of the outlet-forming portion 3b. Here, the thickness of the spike portion 3 refers to the maximum width of the spike portion 3 in cross section. As described below, the outer periphery of the base portion 3c in this embodiment is circular in cross section. Therefore, the thickness of the base portion 3c in this embodiment corresponds to the diameter of this circle. The outer periphery of the outlet-forming portion 3b in this embodiment is shaped like an ellipse. Therefore, the thickness of the outlet-forming portion 3b in this embodiment corresponds to the length of the major axis of this ellipse. Furthermore, the minimum thickness of the base portion 3c refers to the minimum value of the thickness of the base portion 3c. In this embodiment, the thickness of the base portion 3c is uniform in the longitudinal direction A. Therefore, the minimum thickness of the base portion 3 c in this embodiment is the thickness of the base portion 3 c at any position in the longitudinal direction A. Furthermore, the maximum thickness of the outlet forming portion 3 b means the maximum value of the thickness of the outlet forming portion 3 b. The thickness of the outlet forming portion 3 b in this embodiment is uniform in the longitudinal direction A. Therefore, the maximum thickness of the outlet forming portion 3 b in this embodiment is the thickness of the outlet forming portion 3 b at any position in the longitudinal direction A. In this way, since the minimum thickness of the base portion 3 c is the same as or greater than the maximum thickness of the outlet forming portion 3 b, when the spike portion 3 is pierced through the rubber stopper 15, the rubber stopper 15 and the outer peripheral surface of the base portion 3 c of the spike portion 3 can be tightly attached without any gaps. This makes it possible to prevent liquid from leaking between the rubber stopper 15 and the spike portion 3, for example, when the vial 5 is turned upside down and liquid is aspirated from the vial 5 to an aspirating / discharging device through the liquid flow path 2 of the vial adapter 1.

[0031] 5A, the outer circumferential surface of the base portion 3c in this embodiment is circular in cross section. This configuration allows the rubber stopper 15 and the outer circumferential surface of the base portion 3c of the spike portion 3 pierced through the rubber stopper 15 to be more securely and tightly attached without any gaps than when the outer circumferential surface of the base portion 3c is not circular in cross section, thereby further preventing liquid from leaking through the gap between the rubber stopper 15 and the spike portion 3.

[0032] In this embodiment, the outer peripheral surface of the sharpened tip 3a is shaped like an ellipse in cross section, and the lengths of the major and minor axes of the ellipse decrease toward the tip (see FIGS. 5D to 5F). This configuration allows the tip of the spike 3 to be tapered, making it easier to pierce the rubber stopper 15 with the spike 3.

[0033] In this embodiment, the sharpened portion 3 a, the outlet forming portion 3 b, and the base portion 3 c are defined by dividing the spike portion 3 in the longitudinal direction A.

[0034] 7 , the vial adapter 1 of this embodiment has a medical device connection part 10 that forms a connection port 2a that communicates with the liquid flow path 2. With the above configuration, when the medical device connection part 10 is connected to an aspirating / discharging device such as a syringe and the spike part 3 is connected to the vial 5, liquid can be supplied from the aspirating / discharging device to the vial 5 through the liquid flow path 2 of the vial 5 and mixed with the contents inside the vial 5 to form a mixed liquid. Furthermore, the vial 5 can then be turned upside down, and the liquid can be aspirated from the vial 5 into the aspirating / discharging device through the liquid flow path 2 of the vial adapter 1.

[0035] 4, the spike 3 of this embodiment has a gas flow path 11 that forms an open end 11a on the outer surface of the spike 3. With the above configuration, when the spike 3 is connected to the vial 5 and liquid is supplied to the vial 5 through the liquid flow path 2, gas can be discharged from the vial 5 through the gas flow path 11. Furthermore, when the vial 5 is turned upside down and liquid is aspirated from the vial 5 into the aspirating / discharging device through the liquid flow path 2 of the vial adapter 1, gas can be introduced into the vial 5 through the gas flow path 11.

[0036] In this embodiment, the open end 11a of the gas flow path 11 is located on the opposite side of the outlet 2b from the center of the spike 3 when viewed in the longitudinal direction A. With the above configuration, when liquid is supplied to the vial 5 through the liquid flow path 2 with the spike 3 connected to the vial 5, it is possible to prevent the liquid discharged from the liquid flow path 2 into the vial 5 from entering the gas flow path 11. Furthermore, when the vial 5 is turned upside down and liquid is aspirated from the vial 5 into the aspirating / discharging device through the liquid flow path 2 of the vial adapter 1, and gas is introduced into the vial 5 through the gas flow path 11, it is possible to prevent the liquid from bubbling due to the gas.

[0037] 4, the open end 11a of the gas flow path 11 in this embodiment is located closer to the tip than the outlet 2b. With the above configuration, when the vial 5 is inverted, liquid is aspirated from the vial 5 into the aspirating / discharging device through the liquid flow path 2 of the vial adapter 1, and gas is introduced into the vial 5 from the gas flow path 11, bubbling of the liquid due to the gas can be suppressed.

[0038] The medical device connection part 10 of this embodiment is a closed type in which a valve body 10 a is disposed in the connection port 2 a. With this configuration, when the medical device connection part 10 is in a disconnected state, it is possible to prevent foreign matter from entering the liquid flow path 2.

[0039] The vial adapter 1 of this embodiment has a balloon 12 that forms an internal space communicating with the gas flow path 11 and is capable of selectively expanding and contracting. According to the above configuration, by supplying liquid to the vial 5 through the liquid flow path 2, gas discharged from the vial 5 through the gas flow path 11 can be temporarily stored in the internal space of the balloon 12, and then by sucking the liquid from the vial 5 through the liquid flow path 2, the gas can be returned from the internal space of the balloon 12 to the vial 5 through the gas flow path 11. Therefore, when handling an anticancer drug or the like in the vial 5, for example, it is possible to prevent harmful gas from being discharged from the vial 5 into the external space.

[0040] The vial adapter 1 of this embodiment has an inlet valve 13 that allows gas to flow from the external space into the gas flow path 11, while suppressing gas from flowing out from the gas flow path 11 to the external space. With this configuration, when liquid is aspirated from the vial 5 through the liquid flow path 2, even if there is not enough gas in the internal space of the balloon 12 to be introduced into the vial 5 due to the influence of temperature change or the like, the shortage of gas can be introduced through the inlet valve 13.

[0041] The present disclosure is not limited to the above-described embodiments, and various modifications are possible without departing from the spirit of the present disclosure.

[0042] Therefore, the vial adapter 1 according to the embodiment described above can be modified in various ways as long as it is a vial adapter 1 having a spike portion 3 that extends elongatedly from the base end to the tip, defining a longitudinal direction A, and forming a liquid flow path 2 therein, wherein the liquid flow path 2 has an outlet 2b that opens onto the outer peripheral surface of the spike portion 3 in a cross section perpendicular to the longitudinal direction A, and the outlet 2b has an enlarged opening 2b2 in which the opening angle θ defined by two straight lines La, Lb that connect the central axis O of the spike portion 3 and the two ends 7a, 7b of the outlet 2b that extend in the circumferential direction B around the central axis O gradually increases toward the tip.

[0043] The present disclosure relates to a vial adapter.

[0044] 1: vial adapter 2: liquid flow path 2a: connection port 2b: outlet 2b1: base end opening 2b2: enlarged opening 3: spike portion 3a: sharp point 3b: outlet forming portion 3c: base portion 4: notched surface 5: vial 6: baffle surface 7a: end 7b: end 10: medical device connection portion 10a: valve body 11: gas flow path 11a: open end 12: balloon 13: suction valve 15: rubber stopper 15a: cover portion 15b: fixing portion 18: mouth portion A: longitudinal direction of spike portion B: circumferential direction around the central axis of the liquid flow path La: straight line Lb: straight line O: central axis of the liquid flow path W1: width of notched surface W2: width of baffle surface

Claims

1. A vial adapter having a spike portion that extends elongatedly from a base end to a tip end, defining a longitudinal direction, and forming an internal liquid flow path, said liquid flow path having an outlet that opens onto the outer peripheral surface of said spike portion in a cross section perpendicular to said longitudinal direction, said outlet portion having an enlarging opening such that in said cross section, the opening angle defined by two straight lines connecting the central axis of said spike portion and the two ends of said outlet portion that are aligned in the circumferential direction around said central axis gradually increases toward the tip end.

2. A vial adapter as described in claim 1, wherein said spike portion has a baffle surface that guides liquid flowing through said liquid flow path from said base end side to said tip end side toward said outlet.

3. A vial adapter as described in claim 1 or 2, wherein said outlet has a base end opening that is continuous with said base end side of said enlarged opening and whose opening angle is constant regardless of the position in the longitudinal direction.

4. A vial adapter as described in claim 1 or 2, wherein the spike portion has a sharp tip portion consisting of a tapered tip, and an outlet forming portion that forms the outlet and is located closer to the base end than the sharp tip, and the outlet forming portion has an outer peripheral surface that follows an ellipse in the cross section, and the length of the major axis of the ellipse is constant regardless of the position in the longitudinal direction.

5. The vial adapter according to claim 4, wherein the length of the minor axis of the ellipse of said outlet forming portion becomes smaller toward said tip side.

6. A vial adapter as described in claim 4, wherein said spike portion has a root portion connected to the base end side of said outlet forming portion, and the minimum thickness of said root portion is the same as or greater than the maximum thickness of said outlet forming portion.

7. The vial adapter of claim 6, wherein said base portion has an outer circumferential surface that is circular in said cross section.

8. A vial adapter as claimed in claim 1 or 2, wherein said spike has a gas flow passage forming an open end in an exterior surface of said spike.

9. The vial adapter according to claim 8, wherein the open end of the gas flow path is located closer to the tip than the exhaust port.

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