Sterile connector

Abstract

To provide an aseptic connector which sufficiently prevents an erroneous operation even though it has a simple configuration.SOLUTION: Each connector part 10 comprises: a connector body 1 which has a fluid channel 13 having an opening 13a on an opposing surface 11 opposite to a connector part 10 being a coupling partner in the time of coupling; and a film member 2 which is positioned in a folded state with one end bonded and the rest folded on the opposing surface 11 in such a manner that the opening 13a is closed prior to coupling. The connector body 1 comprises a protrusion 14 which protrudes from the opposing surface 11 and which is the protrusion 14 that extends onto a path through which the remaining to be rotated passes so as to prevent the film member 2 from reaching the single state when the remaining of the film member 2 in the folded state rotates from the folded state so as to release the folding toward the single state in which the film member 2 extends in a flat state along the opposing surface 11 with the remaining of the film member 2 extending as it is from the one end without being folded.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a sterile connector that is composed of two connector portions, and achieves fluid communication between the two connector portions by coupling the two connector portions while suppressing intrusion of exogenous contaminants.

Background Art

[0002] In the field of medical devices, medical connectors for connecting tubes through which fluids such as medicinal solutions flow, containers containing such fluids, and medical devices for processing such fluids to one another to allow fluid to flow therebetween have been conventionally known. Such a medical connector is composed of two connector portions, and fluid communication between the two connector portions is achieved by coupling the two connector portions.

[0003] Among such medical connectors, there are those in which the two connector portions are coupled while suppressing intrusion of exogenous contaminants, which are referred to as sterile connectors. Among sterile connectors, a so-called film-type sterile connector is known, in which the two connector portions are coupled in a state where the opening of the fluid flow path in each connector portion is covered with a film, and the two films of these connector portions are pulled out simultaneously to achieve fluid communication (see, for example, Patent Documents 1 to 3). In this type of sterile connector, the fluid flow path is isolated from the outside until the two films are pulled out even in the coupled state, so the risk of contaminants entering the fluid flow path is extremely low.

[0004] In the connector portion of these film-type sterile connectors before joining, one end of the membrane is often adhered to the opening of the fluid flow path, and then the remaining portion of the membrane is folded back so that a part of the remaining portion of the membrane overlaps the adhered end (see, for example, reference numeral 400 in Figure 4A of Patent Document 1 and reference numeral 9 in Figure 1 of Patent Document 3). When the membrane is arranged in this way, when the connector portions are joined and the membrane is pulled out, the membrane peels off from the opening little by little from the upstream portion of the end of the membrane that is adhered to the opening in the direction of pulling out. Therefore, compared to pulling out the membrane in a single layer without folding it back after adhering it to the opening, the impact on the adhesion point of the membrane is reduced and the membrane is pulled out more smoothly, and the stability of the joined state of the sterile connector when the membrane is pulled out is increased. Furthermore, with this membrane arrangement, the outer surface of the membrane, which may be contaminated because it is exposed, is less likely to come into contact with the opening, which is preferable from a hygienic standpoint. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 10307583 [Patent Document 2] Patent No. 6535902 [Patent Document 3] Special Publication No. 2017-505408 [Overview of the project] [Problems that the invention aims to solve]

[0006] However, some users of sterile connectors may use them without knowing the reason for the membrane's fold, and such users may mistakenly try to unfold the membrane, making it a single layer, before pulling it out. Therefore, measures to prevent such errors are desirable.

[0007] One possible method to prevent such errors is to attach a tab to the membrane to act as a grip when pulling it out, and to give that tab a special structure to make it difficult to fold the membrane incorrectly (see, for example, reference numeral 300 in Figures 1 to 4 of Patent Document 1). However, adopting a component with such a special structure would complicate the overall structure of the sterile connector, which could lead to a decrease in the productivity of sterile connector manufacturing.

[0008] In recent years, there has been a growing demand for sterile connectors for the flow of low-flow fluids such as culture media in medical systems used for cell culture and other applications. There is a need to provide more affordable sterile connectors by improving productivity. Therefore, for sterile connectors used for low-flow fluids, there is a particularly high need for a simple design that prevents misuse.

[0009] In light of the above circumstances, the present invention aims to provide a sterile connector that has a simple structure while sufficiently preventing erroneous operation. [Means for solving the problem]

[0010] To solve the above-mentioned problems, the present invention provides the following sterile connector.

[0011] [1] A sterile connector comprising two connector parts, each having a fluid channel, wherein the two connector parts are joined together to enable fluid flow between them while suppressing the intrusion of bacteria from the outside, and each of the two connector parts has a coupling mechanism for coupling to the other connector part on the opposing surface facing the other connector part when the two connector parts are joined, and a connector body having a fluid channel with an opening on the opposing surface, and a strip-shaped membrane member, wherein before the two connector parts are joined, one end is adhered to the opposing surface in a manner that closes the opening of the connector body, and a portion of the remaining portion other than the one end is folded back in a manner that overlaps the one end. A sterile connector comprising: a membrane member which is positioned in a folded state, and after the two connector parts are joined, the other end opposite to the one end is pulled in the direction in which the folded remaining part extends, thereby peeling the one end away from the opposing surface and opening the opening to connect the flow paths of the two connector parts, wherein the connector body has a projection that protrudes from the opposing surface, and the projection extends along the path through which the rotating remaining part passes, preventing the membrane member from reaching the single state when the remaining part of the folded membrane member rotates from the folded state so as to eliminate the fold, toward a single state in which the remaining part of the membrane member extends straight from the one end without being folded and the membrane member extends flat along the opposing surface.

[0012] [2] When the two connector parts are joined, the opposing surfaces of the two connector parts are in contact with each other with the two folded membrane members of the two connector parts in between, and the openings on the opposing surfaces facing each other. The sterile connector described in [1], wherein when the two connector parts are joined, the projections of each of the two connector parts are positioned in a predetermined location that is not obstructed from the opposing surface of the connector part to be joined, so as not to hinder the realization of the contact state.

[0013] [3] The sterile connector as described in [2], wherein the projection is erect from the opposing surface and extends in a wall-like manner along the opposing surface, and the lower part of the wall-like portion on the opposing surface side is missing a notch, the projection prevents the remaining part of the membrane member from rotating from the folded state to the single state, but allows the remaining part of the membrane member to pass between the notch and the opposing surface so that the membrane member becomes the single state.

[0014] [4] The sterile connector according to [3], wherein the membrane member in the single layer state overlaps the projection of the connector portion of the connecting partner with the projection of the projection of the connector portion of the connecting partner with the projection of the projection of the connector portion of the connecting partner with the membrane member in the single layer state, which prevents the two connector portions having the membrane member in the single layer state from being positioned at the predetermined location.

[0015] [5] The sterile connector according to any one of [1] to [4], wherein the two connector portions are identical in shape, and the two connector portions are joined in such a manner that the folded membrane members of each of the two connector portions overlap each other, and the other ends of the two overlapping membrane members are pulled simultaneously so that one end is peeled away from the opposing surface, thereby connecting the flow paths of the two connector portions, and ring-shaped holes for pulling the other ends of the two membrane members simultaneously are formed at the same position on the two membrane members.

[0016] [6] The sterile connector according to [5], wherein the membrane member is integrally formed from the same material, including the other end on which the ring-shaped hole is formed.

[0017] [7] The sterile connector according to [5], wherein the membrane member is formed by adhering a ring-shaped member, made of a different material from the membrane body, to one end of a membrane body having a strip shape, as the other end.

[0018] [8] The connector body has, as the coupling mechanism, a ratchet pawl protruding from the opposing surface and a ratchet pawl receiving portion recessed from the opposing surface, the ratchet pawl and the ratchet pawl receiving portion respectively engage with the ratchet pawl receiving portion and the ratchet pawl of the mating connector part of the coupling counterpart, and the engagement couples the two connector parts to realize the abutting state of the opposing surfaces of the two connector parts. The sterile connector according to any one of [2] to [4]. [Effects of the Invention]

[0019] In the sterile connector of the present invention, rotating the folded portion (remaining portion) to bring the membrane member into a single-layer state so as to release the folding of the membrane member is obstructed by the protrusion protruding from the opposing surface. By merely providing such a protrusion, an erroneous operation in which a user accidentally releases the folding of the membrane member to bring it into a single-layer state and then pulls out the membrane member is prevented. Therefore, in the present invention, a sterile connector that sufficiently prevents erroneous operations with a simple configuration is realized. Such effects are particularly useful for sterile connectors for the flow of low-flow rate fluids, for which demand is increasing. [Brief Description of the Drawings]

[0020] [Figure 1] It is an external perspective view of a connector part that is a component of the sterile connector of the embodiment. [Figure 2] It is a top view of the connector part of FIG. 1 viewed from the V direction in FIG. 1. [Figure 3] It is a side view of the connector part of FIG. 1 viewed from the S1 direction in FIG. 1. [Figure 4] It is a side view of the connector part of FIG. 1 viewed from the S2 direction in FIG. 1. [Figure 5] It is an external perspective view showing a state where the remaining portion of the membrane member in FIG. 3 and FIG. 4 is further folded. [Figure 6] It is a side view of the sterile connector of the present embodiment immediately before the two connector parts 10 are coupled. [Figure 7] This is a side view of the sterile connector immediately after the two connector portions of Fig. 6 are coupled to each other. [Figure 8] This is an external perspective view of the sterile connector of Fig. 7. [Figure 9] This is an external perspective view of the sterile connector when the membrane member is pulled out from the two connector portions of Fig. 7 and the flow paths are in communication with each other. [Figure 10] This is an explanatory diagram for explaining the prevention of erroneous operation by the protrusions shown in Fig. 1 to Fig. 4. [Figure 11] This is a side view showing the membrane member in a single-layer state as the remaining part of the membrane member passes between the cutout portion and the opposing surface. [Figure 12] This is an external perspective view of a connector portion in which the part having the cutout portion in the protrusion has a shape different from that in Fig. 1. [Figure 13] This is an external perspective view of a connector portion in which the part having the cutout portion in the protrusion has a shape different from that in Fig. 1. [Figure 14] This is an external perspective view of a connector portion in which the part having the cutout portion in the protrusion has a shape different from that in Fig. 1. [Figure 15] This is an external perspective view of a connector portion in which the part having the cutout portion in the protrusion has a shape different from that in Fig. 1. [Figure 16] This is an external perspective view of a connector portion in which the part having the cutout portion in the protrusion has a shape different from that in Fig. 1. [Figure 17] This is an external perspective view of a connector portion provided with a membrane member formed by adhering a ring-shaped member formed of a material different from that of the belt-shaped membrane main body as the other end portion to the end portion of the belt-shaped membrane main body. [Mode for Carrying Out the Invention]

[0021] Hereinafter, embodiments of the present invention will be described with reference to the drawings. It should be understood that the present invention is not limited to the following embodiments, and appropriate design changes, improvements, and the like can be made based on the ordinary knowledge of those skilled in the art without departing from the spirit of the present invention.

[0022] The sterile connector of this embodiment consists of two connector sections, each having a fluid flow path. In this sterile connector, the intrusion of bacteria from the outside is suppressed, and fluid flow between the two connector sections is achieved by connecting these two connector sections and connecting their flow paths. These two connector sections have the same configuration, and below, we will first describe one of these two connector sections, which is a single connector section.

[0023] Figure 1 is an external perspective view of the connector part 10, which is a component of the sterile connector of this embodiment, and Figure 2 is a top view of the connector part 10 of Figure 1 as seen from direction V in Figure 1. Furthermore, Figure 3 is a side view of the connector part 10 of Figure 1 as seen from direction S1 in Figure 1, and Figure 4 is a side view of the connector part 10 of Figure 1 as seen from direction S2 in Figure 1.

[0024] The connector section 10 comprises a connector body 1 and a membrane member 2.

[0025] The connector body 1 has a coupling mechanism 12 for coupling to the other connector part 10 on an opposing surface 11 that faces the other connector part 10 when two connector parts 10 are coupled. The connector body 1 also has a fluid flow path 13 with an opening 13a on the opposing surface 11. Note that the flow path 13 and its opening 13a are not visible from the outside and are shown as dotted lines in Figures 1 and 2. Here, a mounting portion 131 is formed on the side of the flow path 13 opposite to the opening 13a (see Figure 1), and a medical tube or the like from the outside of the sterile connector of this embodiment is attached to this mounting portion 131 to allow fluid to flow in from the outside and out to the outside. The connector body 1 also has a projection 14 that protrudes from the opposing surface 11. As will be described later, the projection 14 is a part that prevents user error, and the projection 14 will be described in detail later.

[0026] The membrane member 2 is a strip-shaped member. Before the two connector parts 10 are joined, the membrane member 2 is positioned with one end 21 bonded to the opposing surface 11 in such a manner that it closes the opening 13a of the connector body 1, and the remaining portion 22 other than the one end 21 is folded back so that a part of it overlaps with the one end 21 (see Figure 4). Hereinafter, this state will be referred to as the folded state. As will be described later, after the two connector parts 10 are joined, the other end 23 opposite to the one end 21 is pulled in the direction in which the folded remaining portion 22 extends (in the direction of the arrows in Figures 3 and 4), and the one end 21 is peeled away from the opposing surface 11. In this way, the membrane member 2 opens the opening 13a and connects the flow paths of the two connector parts 10.

[0027] In Figures 3 and 4, the remaining portion 22 of the membrane member 2 in the folded state is shown as extending straight in one direction from the folded point, but the remaining portion 22 may be further folded from the viewpoint of making the connector portion 10 more compact.

[0028] Figure 5 is an external perspective view showing the remaining portion 22 of the membrane member 2 in Figures 3 and 4 in a further folded state.

[0029] As shown in Figure 5, the connector portion 10 becomes more compact when the membrane member 2 is further folded, which is preferable as it is the state before use. From this state in Figure 5, rotating the further folded portion of the membrane member 2 in the direction of arrow A1 results in the state in Figure 1.

[0030] In the above, the connector body 1 and the membrane member 2 have been described as components of the connector portion 10. However, the connector portion 10 also includes an annular sealing member (not shown) positioned around the opening 13a on the opposing surface 11 as another component. The annular sealing member is made of an elastic material and is used to maintain the sealing performance of the flow path 13 during and after the two connections. Such annular sealing members are similar to conventional ones (see, for example, reference numeral 230 in Patent Document 2 and reference numeral 6 in Patent Document 3), and no further detailed explanation of the annular sealing member is provided.

[0031] Next, the connection of the two connector parts 10 in this embodiment and the communication of the flow path 13 will be described. In the following description, the external medical tubing and the like attached to the mounting part 131 in Figure 1 will be omitted from the illustration, and the communication of the flow path 13 will be described accordingly.

[0032] Figure 6 is a side view of the sterile connector 100 of this embodiment just before the two connector parts 10 are joined, and Figure 7 is a side view of the sterile connector 100 immediately after the two connector parts 10 of Figure 6 are joined. Figure 8 is an external perspective view of the sterile connector 100 of Figure 7, and Figure 9 is an external perspective view of the sterile connector 100 when the membrane member 2 is withdrawn from the two connector parts 10 of Figure 7 and the flow path is connected.

[0033] In the sterile connector 100 of this embodiment, immediately before the joining of the two connector sections 10, the opposing surfaces 11 of each connector section 10 face each other, and the flow paths 13 of the two connector sections 10 are positioned on the extensions of each other (see the dashed line in Figure 6). In this state, the two connector sections 10 approach each other relatively, as shown by the thick arrows in Figure 6, and are joined by the joining mechanism 12 in Figures 1 and 2 to the state shown in Figures 7 and 8. At this time, the membrane members 2 of the two connector sections 10, which are in a folded state (see the state of the membrane member 2 in Figure 4), overlap each other, and a contact state is achieved in which the opposing surfaces 11 come into contact with each other with the openings 13a facing each other with the two folded membrane members 2 in between. Note that in the contact state, the two membrane members 2 of the two connector sections 10 overlap each other, so in Figure 7 they are shown as a single thick line, and in Figure 8 they are shown as if they were a single membrane member 2.

[0034] Here, the coupling mechanism 12 can be, for example, one having a ratchet pawl 121 protruding from the opposing surface 11 and a ratchet pawl receiving portion 122 recessed from the opposing surface 11, as shown in Figures 1 and 2. In the state shown in Figure 6, the ratchet pawl 121 and the ratchet pawl receiving portion 122 engage with the ratchet pawl receiving portion 122 and the ratchet pawl 121 of the opposing connector portion 10. More specifically, the hook-shaped tip of the ratchet pawl 121 catches on a hook inside the ratchet pawl receiving portion 122 and fits into the ratchet pawl receiving portion 122, thereby engaging the ratchet pawl receiving portion 122 and the ratchet pawl 121. This engagement connects the two connector portions 10 and realizes the contact state of the opposing surfaces 11 described above.

[0035] In this coupling mechanism 12 using the ratchet pawl 121 and ratchet pawl receiving part 122, the two connector parts 10 are coupled simply by inserting the ratchet pawl 121 into the ratchet pawl receiving part 122. Therefore, rotational operation or separate fixing means are unnecessary, and coupling the two connector parts 10 is extremely easy. However, in the present invention, coupling means other than the ratchet method described above may be used as the coupling mechanism. For example, a method of fixing the two connector parts 10 with screws may be used.

[0036] The explanation of the connection of the two connector parts 10 and the communication of the flow path 13 will continue.

[0037] As shown in Figures 7 and 8, after the two connector parts 10 are joined and the opposing surfaces 11 come into contact, the other ends 23 of the two overlapping membrane members 2 are then simultaneously pulled in the direction of arrow A2 in Figure 8. As a result, one end 21 of each membrane member 2 (not shown in Figure 8; see Figures 3 and 4) is peeled away from the opposing surface 11, the two membrane members 2 are pulled out (see Figure 9), and the flow paths 13 of the two connector parts 10 (see Figure 7) are opened up.

[0038] The above describes the connection of the two connector parts 10 and the communication of the flow path 13 in the sterile connector 100 of this embodiment.

[0039] In the sterile connector 100 of this embodiment, as shown in Figures 3 and 4, one end 21 of the membrane member 2 is bonded to the opening 13a of the fluid flow path 13, and then the remaining portion 22 is folded back, so that a part of the remaining portion 22 overlaps the one end 21. With this arrangement, when the two connector portions 10 are joined together and the membrane member 2 is pulled out as shown in Figure 8, the membrane gradually peels away from the opening 13a from the upstream portion of the bonded end 21 of the membrane member 2 in the direction of pulling out (arrow A2 direction in Figure 8). Therefore, compared to the case where the membrane member 2 is bonded to the opening 13a and then pulled out in a single layer without folding back the remaining portion 22 of the membrane member 2, the impact on the bonded area of ​​the membrane member 2 is reduced and the membrane is pulled out more smoothly. As a result, the stability of the bonded state of the sterile connector 100 when the membrane member 2 is pulled out is increased.

[0040] However, some users of the sterile connector 100 may use it without knowing the reason for the folding of the membrane member 2. It is quite conceivable that such users might mistakenly try to unfold the membrane member 2 as shown in Figures 3 and 4, making it a single layer, before joining the two connector parts 10 and pulling out the membrane member 2. In this embodiment, the sterile connector 100 is provided with projections 14 that protrude from the opposing surfaces 11 of the connector body 1, as shown in Figures 1 to 4, in order to prevent such erroneous operation. The prevention of erroneous operation by projections 14 will be explained below.

[0041] Figure 10 is an explanatory diagram illustrating the prevention of erroneous operation by the protrusions 14 shown in Figures 1 to 4.

[0042] Suppose the user mistakenly rotates the remaining portion 22 of the folded membrane member 2 in Figures 3 and 4 in the direction of A3 in Figure 10, so as to eliminate the fold, moving from the folded state to the single-layer state. Here, the single-layer state refers to the state in which the remaining portion 22 of the membrane member 2 in Figures 3 and 4 extends straight from one end 21 without being folded as in Figures 3 and 4, and the entire membrane member 3 extends flat along the opposing surface 11 (see also Figure 11, which will be discussed later).

[0043] As shown in Figure 10, the projection 14 extends along the path through which the remaining portion 22 of the membrane member 2 rotates in the direction A3 in Figure 10. The presence of this projection 14 prevents the membrane member 2 from reaching the single-layer state described above. The fact that the projection 14 is located along the rotation path of the remaining portion 22 of the membrane member 2 can also be seen in Figure 2, which shows the connector body 1 viewed from above (from the direction V in Figure 1), as a part of the projection 14 lies between the two dashed lines that are extensions of the remaining portion 22.

[0044] Thus, in the sterile connector 100 of this embodiment, the projection 14 protruding from the opposing surface 11 prevents the user from rotating the folded portion (the remaining portion 22) to unfold the membrane member 2 and make it a single layer. By simply providing such a projection 14, the user is prevented from accidentally unfolding the membrane member 2 and making it a single layer before pulling out the membrane member 2. Therefore, in this embodiment, a sterile connector that sufficiently prevents errors despite its simple configuration is realized. This effect is particularly useful for sterile connectors for the flow of low-flow fluids, for which demand is increasing.

[0045] Here, when the two connector parts 10 are joined, the projections 14 of each of the two connector parts are positioned in a predetermined location that is not obstructed by the contact state shown in Figures 7 and 8, away from the opposing surface 11 of the connector part 10 being joined. This predetermined location will be explained in more detail using Figure 8. The connector part 10 being joined (the upper connector part 10 in Figure 8) has a recess 17 formed on the periphery of the connector part 10, centered on the flow path 13 (see Figure 7), which is recessed inward (i.e., on the side of the flow path 13 in Figure 7). When the two connector parts 10 are joined, the projection 14 of the lower connector part 10 in Figure 8 is positioned in this recess 17 of the connector part 10 being joined, and does not come into contact with the opposing surface 11 of the connector part 10 being joined during the joining operation from the state in Figure 6 to the state in Figure 7. Since this recess 17 is the predetermined position described above, and the projection 14 enters the recess 17 without colliding with the opposing surface 11 of the connector portion 10 to be connected, the presence of the projection 14 does not prevent the realization of the contact state shown in Figures 7 and 8.

[0046] In this embodiment, the predetermined position that is away from the opposing surface 11 and does not hinder the realization of the contact state was the recess 17 on the peripheral edge of the connector portion 10. However, in the present invention, other positions may be adopted as the predetermined position. For example, the projection 14 may be housed in a slit-shaped groove that opens to the opposing surface 11 when connected to the opposing surface 11. In this case, the slit-shaped groove that houses the projection 14 becomes the predetermined position.

[0047] Let's continue the explanation of the protrusion 14.

[0048] The projection 14 is erected from the opposing surface 11 and extends in a wall-like manner along the opposing surface 11. For example, in Figure 1, the projection 14 is erected from the opposing surface 11 at the periphery of the opposing surface 11 and extends in a wall-like manner along the periphery of the opposing surface 11. Here, as shown in Figure 1, the projection 14 has a notch 15 in which the lower part of this wall-like structure on the opposing surface 11 side is missing. As described above in Figure 10, the projection 14 prevents the remaining part 22 of the membrane member 2 (see Figure 3) from rotating from the folded state shown in Figures 1 to 4 to reach the single-layer state. However, the projection 14 allows the remaining part 22 of the membrane member 2 to pass between the notch 15 and the opposing surface 11, so that the membrane member 2 can reach the single-layer state.

[0049] Figure 11 is a side view showing the membrane member 2 in a single-layer state, where the remaining portion 22 of the membrane member 2 passes between the notch 15 and the opposing surface 11.

[0050] Even if it is impossible to achieve a single layer state by rotating the remaining portion 22 of the membrane member 2, it is possible to achieve the single layer state shown in Figure 11 by twisting the remaining portion 22 of the membrane member 2 to bypass the projection 14 and pass the remaining portion 22 between the notch 15 and the opposing surface 11 (see area P in Figure 11). In reality, the user will realize they have made a mistake when they find that even if they rotate the remaining portion 22 of the membrane member 2, they cannot achieve a single layer state due to the presence of the projection 14 as described above in Figure 10. Even if the user manages to bypass the projection 14 and forcibly achieve the single layer state shown in Figure 11, they will realize they have made a mistake at the joining stage because, as will be described later, the two connector portions 10 cannot be joined in this state. In any case, the effect of the projection 14 in preventing user errors is not diminished by the presence of the notch 15. So why bother providing the notch 15? It is for manufacturing reasons, as will be explained below.

[0051] When bonding one end 21 of the film member 2 to the opposing surface 11, temperature control such as heat treatment is often applied to the end 21. In such cases, from the viewpoint of preventing the remaining portion 22 of the film member 2 from being affected by the temperature control, it is preferable to bond one end 21 of the film member 2 to the opposing surface 11 in the single-layer state shown in Figure 11. If a notch 15 exists in the projection 14, after bonding one end 21 of the film member 2 to the opposing surface 11 in the single-layer state, the remaining portion 22 of the film member 2 can be passed between the notch 15 and the opposing surface 11 while bypassing the projection 14, thereby achieving the folded state shown in Figures 1 to 4. In other words, the feature of the projection 14 that allows the folded film member 2 to become a single layer state due to the presence of the notch 15 ensures that the single-layer film member 2 with one end 21 bonded to it can be deformed into a folded state during the manufacturing stage.

[0052] The following explains why the membrane member 2 cannot connect the two connector portions 10, which are in the single-layer state shown in Figure 11.

[0053] In Figure 11, the membrane member 2 in its single-layer state overlaps with the projection 14 of the connector part 10, which is the connector part 10 to be connected to in Figure 11, at a predetermined position where the two connector parts will be located when connected. In fact, the membrane member 2 in its single-layer state in Figure 11 extends to the band-shaped region shown by the two dashed lines in Figure 2, and the recess 17 that provides the predetermined position, as explained in Figure 8, is located between the two dashed lines as shown in Figure 2. The presence of the membrane member 2 in this single-layer state makes it impossible to position the projection 14 of the connector part 10 to the predetermined position (see recess 17 in Figure 8), and as a result, the connection of the two connector parts 10 in the state shown in Figure 11 is prevented. Thus, even if a user bypasses the projection 14 and puts the membrane member 2 into the single-layer state shown in Figure 11, the erroneous operation of connecting the two connector parts 10 in this state is sufficiently prevented by the presence of the projection 14.

[0054] In the above description, the projection 14 had a pointed triangular shape in the portion having the notch 15. However, in the present invention, other shapes may be used for the portion having the notch. Below, variations of the connector portion in which the portion having the notch of the projection has a different shape from that shown in Figure 1 will be described.

[0055] Figures 12 to 16 are external perspective views of the connector portion where the notched portion of the protrusion has a different shape from that shown in Figure 1.

[0056] In Figures 12 to 16, the same reference numerals are used for components identical to those in Figure 1, and redundant explanations are omitted. The only difference between the connector portion in Figures 12 to 16 and the connector portion 10 in Figure 1 is that the portion with a notch in the protruding part has a different shape than that in Figure 1. Therefore, only this difference will be explained below, and for explanations of other aspects of the connector portion, please refer to the explanation of the connector portion 10 in Figure 1.

[0057] In the connector body 1A of the connector section 10A in Figure 12, the projection 14A has a triangular shape with a notched portion 15A that is not as sharp as in Figure 1. Even with such a projection 14A, it can perform the same function as the projection 14 in Figure 1.

[0058] In Figures 13 to 16, the projections 14B, 14C, 14D, and 14E of the connector bodies 1B, 1C, 1D, and 1E of the connector parts 10B, 10C, 10D, and 10E have notches 15B, 15C, 15D, and 15E, respectively, which are quadrilaterals rather than triangles as in Figure 1. However, the part with notch 15C in Figure 14 is a quadrilateral that is shorter in length but has a similar width towards the tip compared to Figure 13. On the other hand, the part with notch 15D in Figure 15 is a quadrilateral that is narrower in width and has a similar length compared to Figure 13. Also, the part with notch 15E in Figure 16 is a quadrilateral that is narrower in width and shorter in length compared to Figure 13. Even if the parts with notches are quadrilateral projections, they can perform the same function as the projection 14 in Figure 1.

[0059] The following describes the characteristic features other than the protrusions. First, we will describe the characteristic features of the membrane member.

[0060] As shown in Figures 1 and 2, a ring-shaped hole is formed at the other end of the membrane member 2 (see also Figure 3) to simultaneously pull the two overlapping membrane members 2 when the two connector parts 10 are joined. This ring-shaped hole is formed at the same position on the two membrane members 2 of the two connector parts 10 that are joined, and when the two membrane members 2 overlap when the two connector parts 10 are joined, the two ring-shaped holes also overlap, as shown in Figure 8, making them appear as if they were a single ring-shaped hole.

[0061] The formation of these ring-shaped holes makes it extremely easy to pull the two membrane members 2 simultaneously. Furthermore, the ring-shaped holes can be used as a guide to easily align the two membrane members 2.

[0062] Here, the membrane member 2 of the connector portion 10 in Figure 1 may be integrally formed from the same material, including the other end portion 23 in which a ring-shaped hole is formed.

[0063] This configuration allows for the manufacture of a membrane member 2 with a ring-shaped hole without increasing the number of parts, resulting in high productivity in sterile connector manufacturing.

[0064] However, in the present invention, the membrane member may be formed by bonding a ring-shaped member, made of a different material from the membrane body, to one end of a strip-shaped membrane body, with the other end being made of a different material from the membrane body. Such embodiments will be described below.

[0065] Figure 17 is an external perspective view of a connector portion 10X, which has a membrane member 2X formed by bonding a ring-shaped member made of a different material from the membrane body 24X to one end of a strip-shaped membrane body 24X, with the other end 23X being the membrane member 2X formed by bonding a ring-shaped member made of a different material from the membrane body 24X to the other end 23X.

[0066] In Figure 17, the same reference numerals are used for components that are the same as those in Figure 1, and redundant explanations are omitted. The only difference between the connector portion 10X in Figure 17 and the connector portion 10 in Figure 1 is that the other end 23X of the membrane member 2X is formed by bonding a ring-shaped member made of a different material from the membrane body 24X. Therefore, only this difference will be explained below, and for explanations of other aspects of the connector portion 10X, please refer to the explanation of the connector portion 10 in Figure 1.

[0067] In this configuration, since the other end 23X of the membrane member 2X is made of a different material from the membrane body 24X, the number of parts increases slightly compared to the connector part 10 in Figure 1. However, the other end 23X can be made of a different material from the membrane body 24X, for example, a material that is stronger and more durable than the membrane body 24X, or a material that feels better to the touch than the membrane body 24X when pulled with a finger, thereby improving operability.

[0068] Next, we will describe the distinctive features of the connector body (excluding the protruding parts).

[0069] As shown in Figures 1, 3, and 4, grooves 16 are formed on both sides (see Figures 3 and 4) of the connector body 1 surrounding the flow path 13 (see Figure 1). In the field of sterile connectors, it has been suggested that in the near future, the connection operation of sterile connectors may be performed by machines such as robots rather than by humans, and a structure like the grooves 16 is suitable for gripping the connector body 1 when a machine such as a robot connects a sterile connector. In fact, the connector body 1 can be easily gripped by simply inserting a rod-shaped member into each of the grooves 16 on both sides of the connector body 1 and gripping the connector body 1.

[0070] The above describes the embodiments of the present invention.

[0071] In the above description, each connector body had a shape in which a cylindrical portion having a mounting portion 131 and extending cylindrically around the flow path 13 was connected to a disc-shaped portion having an opposing surface 11 and spreading out in a disc shape around the flow path 13. However, in the present invention, such a shape is not essential, and the connector may have a shape in which a hollow rectangular prismatic portion is connected instead of the cylindrical portion, and a rectangular flat plate portion is connected instead of the disc-shaped portion. [Industrial applicability]

[0072] This invention is useful for realizing a sterile connector that has a simple structure yet effectively prevents misoperation. [Explanation of symbols]

[0073] 1, 1A, 1B, 1C, 1D, 1E: Connector body, 2,2X: Membrane member, 10, 10A, 10B, 10C, 10D, 10E, 10X: Connector section, 11: Opposite side, 12: Coupling mechanism, 13: Flow channel, 13a: opening, 14,14A,14B,14C,14D,14E:Protrusion, 15, 15A, 15B, 15C, 15D, 15E: Notched section, 16: Groove, 17: Recess, 21: One end, 22: The remaining part 23,23X: Other end, 24X: Membrane body, 100: Sterile connector, 121: Ratchet claw, 122: Ratchet pawl receiving section, 131: Mounting part, P: Area.

Claims

1. A sterile connector comprising two connector sections, each having a fluid flow path, wherein the two connector sections are joined together, and the fluid flow between the two connector sections is realized by connecting the flow paths of the two connector sections, while suppressing the intrusion of bacteria from the outside, Each of the two connector sections mentioned above is The connector body has a coupling mechanism for coupling to the connector of the other connector on the opposing surface facing the other connector when the two connector parts are coupled, and has a fluid flow path with an opening on the opposing surface, A membrane member having a strip shape, wherein, before the two connector parts are joined, one end is adhered to the opposing surface in such a manner that it closes the opening of the connector body, and the remaining portion other than the one end is folded back so that a part of the remaining portion overlaps the one end, and after the two connector parts are joined, the other end opposite to the one end is pulled in the direction in which the folded remaining portion extends, thereby peeling the one end away from the opposing surface, opening the opening and connecting the flow paths of the two connector parts, the membrane member comprising, The connector body has a projection that protrudes from the opposing surface, and the projection extends along the path through which the rotating remaining portion of the membrane member passes, preventing the membrane member from reaching the single-layer state when the remaining portion of the folded membrane member rotates from the folded state to eliminate the fold, so as to move toward a single-layer state where the membrane member extends flat along the opposing surface without the remaining portion of the membrane member being folded back, When the two connector parts are joined, the opposing surfaces of the two connector parts come into contact with each other, with the two folded membrane members of the two connector parts in between, and the openings on the opposing surfaces facing each other. When the two connector parts are connected, the projections of each of the two connector parts are positioned in a predetermined location that is not obstructed from the opposing surface of the connector part to be connected, and that does not hinder the realization of the contact state. The projection is erected from the opposing surface and extends in a wall-like manner along the opposing surface, and has a notch in which the lower part of the wall-like portion on the opposing surface side is missing, and the projection prevents the remaining part of the membrane member from rotating from the folded state to the single-layer state, while allowing the remaining part of the membrane member to pass between the notch and the opposing surface so that the membrane member becomes the single-layer state, in a sterile connector.

2. The sterile connector according to claim 1, wherein the membrane member in the single layer state overlaps the projection of the connector portion of the connecting partner with which the two connector portions are connected at the predetermined position where the two connector portions are located when the two connector portions are connected, and the connection between the two connector portions having the membrane member in the single layer state is prevented by the projection of the connector portion of the connecting partner which cannot be positioned at the predetermined position due to the presence of the membrane member in the single layer state.

3. The two connector portions have the same shape, and the two connector portions are joined in such a manner that the folded membrane members of each of the two connector portions overlap each other, and the other ends of the two overlapping membrane members are pulled simultaneously, causing one end to peel away from the opposing surface, thereby connecting the flow paths of the two connector portions. The sterile connector according to claim 1 or 2, wherein a ring-shaped hole for simultaneously pulling the other end of each of the two membrane members is formed at the same position on both membrane members.

4. The sterile connector according to claim 3, wherein the membrane member, including the other end where the ring-shaped hole is formed, is integrally formed from the same material.

5. The sterile connector according to claim 3, wherein the membrane member is formed by adhering a ring-shaped member, made of a different material from the membrane body, to one end of a membrane body having a strip shape, as the other end.

6. The sterile connector according to claim 1 or 2, wherein the connector body has, as the coupling mechanism, a ratchet pawl protruding from the opposing surface and a ratchet pawl receiving portion recessed from the opposing surface, and the ratchet pawl and the ratchet pawl receiving portion engage with the ratchet pawl receiving portion and the ratchet pawl of the connector portion to be coupled, and the two connector portions are coupled by this engagement, thereby achieving the contact state of the opposing surfaces of the two connector portions.

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