Aseptic connection device

Abstract

An aseptic connection device (1) has a pair of aseptic connection units (2). Each of the aseptic connection units (2) comprises: a connection body (100); a connector (200) that is formed as a member separate from the connection body (100), is inserted into an insertion hole (110h) of the connection body (100), and forms a flow path (FL); a seal member (300) that is disposed inside the connector; a cover (400) that is connected to the connection body; a protective sheet (500) that protects the seal member; and a stopper (600) that restricts the detachment of the connector (200) from the connection body (100). The connector (200) has: a fitting part (210) that fits into the insertion hole (110h) of the connection body (100); and a protrusion (220) that protrudes from the insertion hole. The stopper (600) has: a protrusion-contacting part (612) that comes into contact with the protrusion; and a body-contacting part (622) that comes into contact with the connection body.

Description

Sterile Connection Device

[0001] The present invention relates to a sterile connection device.

[0002] For example, U.S. Patent Application Publication No. 2013 / 0289517 discloses a sterile coupling arrangement including a pair of sterile coupling devices, each including a main body, a seal member, a protective cover, and a membrane, wherein the main body includes a conduit connection.

[0003] US Patent Application Publication No. 2013 / 0289517

[0004] For a sterile coupling device such as that described in U.S. Patent Application Publication No. 2013 / 0289517, it is desirable to have both strength and chemical resistance and stability, so the main body must be formed from a material that satisfies these requirements.

[0005] An object of the present invention is to provide a sterile connection device that allows greater freedom in material selection.

[0006] A sterile connection device according to one aspect of the present invention is a sterile connection device having a pair of sterile connection units connectable to each other, each of the sterile connection units comprising: a connection body having an insertion hole; a connector formed as a separate member from the connection body and inserted into the insertion hole of the connection body to form a fluid flow path; a sealing member disposed inside the connector and constituting part of the flow path; a cover connected to the connection body; a protective sheet in contact with the sealing member so as to block the flow path and protect the sealing member; and a stopper that prevents the connector from being removed from the connection body, wherein the connector has a fitting portion that fits into the insertion hole of the connection body and a protrusion that is connected to the fitting portion and protrudes from the insertion hole, and the stopper has a protrusion abutment portion that abuts against the protrusion in a direction parallel to the axial direction of the protrusion, and a body abutment portion that abuts against the connection body in a direction parallel to the axial direction.

[0007] According to the present invention, it is possible to provide a sterile connection device that allows for greater freedom in material selection.

[0008] 5 is a perspective view showing the cover of a sterile connection device in one embodiment of the present invention in a clamping position. FIG. 6 is a perspective view showing the cover of a sterile connection device in an open position. FIG. 7 is a view showing a pair of sterile connection units connected to each other. FIG. 8 is a view showing the pair of sterile connection units shown in FIG. 3 with the cover and protective sheet removed. FIG. 9 is a front view of a sterile connection unit. FIG. 10 is a cross-sectional view taken along line VI-VI in FIG. 5. FIG. 11 is a perspective view showing the sterile connection unit with the cover and protective sheet removed. FIG. 12 is a cross-sectional perspective view of a pair of connected sterile connection units. FIG. 13 is a perspective view showing the state before a connector and a stopper are connected to a connection main body. FIG. 14 is a perspective view showing the state before a stopper is connected to a connector connected to the connection main body. FIG. 15 is a cross-sectional view of a pair of sterile connection units with the cover in a clamping position. FIG. 16 is a cross-sectional view of a pair of sterile connection units with the cover in an open position. FIG. 17 is a cross-sectional view of a pair of connected sterile connection units with the cover and protective sheet removed.

[0009] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described with reference to the accompanying drawings, in which the same or corresponding elements are designated by the same reference numerals.

[0010] Figure 1 is a perspective view showing a sterile connection device in one embodiment of the present invention with the cover in a clamping position. Figure 2 is a perspective view showing the cover of the sterile connection device in an open position. Figure 3 is a view showing a pair of sterile connection units connected to each other. Figure 4 is a view showing the pair of sterile connection units shown in Figure 3 with the covers and protective sheets removed. This sterile connection device 1 is used for connecting lines for chemical solutions, etc.

[0011] 1 to 6, the sterile connection device 1 has a pair of connectable sterile connection units 2. The pair of sterile connection units 2 have the same structure. Each sterile connection unit 2 includes a connection body 100, a connector 200, a seal member 300, a cover 400, a protective sheet 500, and a stopper 600.

[0012] The connector body 100 is made of synthetic resin etc. The connector body 100 has a main body 110, a first coupling part 120 and a second coupling part 130.

[0013] The main body 110 has an insertion hole 110h. The insertion hole 110h is formed in the center of the main body 110. A part of the connector 200 can be inserted through the insertion hole 110h. The main body 110 is formed in a block shape.

[0014] 6 and 9, the main body 110 has an enclosure 112. The enclosure 112 has an inner circumferential surface that defines the insertion hole 110h. The enclosure 112 is formed in a cylindrical shape.

[0015] The first connecting portion 120 is connected to the main body 110. The first connecting portion 120 is formed on one side (the right side in FIG. 5) of the surrounding portion 112 in a direction perpendicular to the central axis thereof.

[0016] The second coupling portion 130 is connected to the main body 110. The second coupling portion 130 is formed on the other side (the left side in FIG. 5) of the surrounding portion 112 in a direction perpendicular to the central axis thereof.

[0017] The first coupling portion 120 of one of the pair of sterile connection units 2 is connectable to the second coupling portion 130 of the other of the pair of sterile connection units 2. The second coupling portion 130 of one of the pair of sterile connection units 2 is connectable to the first coupling portion 120 of the other of the pair of sterile connection units 2.

[0018] As shown in FIGS. 5, 7, and 8, the first coupling portion 120 has a first wall portion 122 and a first claw portion 124.

[0019] The first wall portion 122 is connected to the main body 110. The first wall portion 122 extends in a direction parallel to the central axis of the enclosure portion 112. The first wall portion 122 is flexible.

[0020] The first claw portion 124 is formed at the tip of the first wall portion 122. The first claw portion 124 protrudes from the tip of the first wall portion 122 toward the insertion hole 110h.

[0021] As shown in FIGS. 5, 7, and 8, the second coupling portion 130 has a second wall portion 132 and a second claw portion 134.

[0022] The second wall 132 is connected to the main body 110. The second wall 132 extends in a direction parallel to the central axis of the enclosure 112. The second wall 132 of one of the pair of sterile connection units 2 has a shape that receives the first wall 122 of the other of the pair of sterile connection units 2.

[0023] The second claw 134 is connected to the second wall 132. The second claw 134 protrudes from the inner circumferential surface of the second wall 132 in a direction away from the insertion hole 110h. The second claw 134 of one of the pair of sterile connection units 2 is engageable with the first claw 124 of the other of the pair of sterile connection units 2.

[0024] When the first claw portion 124 of one of the pair of sterile connection units 2 engages with the second claw portion 134 of the other of the pair of sterile connection units 2, the first wall portion 122 bends to allow the first claw portion 124 to overcome the second claw portion 134.

[0025] The connector 200 is formed as a separate member from the connection body 100. The connector 200 is made of synthetic resin or the like. The connector 200 may be formed of a material different from the material that forms the connection body 100. For example, it is preferable that the connection body 100 is formed of a material that satisfies the functions (strength, etc.) required of the connection body 100, and the connector 200 is formed of a material that satisfies the functions (resistance to chemical solutions, stability, etc.) required of the connector 200.

[0026] The connector 200 is inserted into the insertion hole 110h of the connection body 100. The connector 200 forms a flow path FL for a fluid (air, a chemical solution, etc.). The connector 200 can be connected to, for example, a tube 10 (see FIG. 6). As shown in FIGS. 6, 8, and 9, the connector 200 has a fitting portion 210 and a protrusion 220.

[0027] The mating portion 210 is fitted to the main body 110. The mating portion 210 has a step 212. The step 212 abuts against the main body 110 in the insertion direction (to the right in FIG. 6 ) in which the connector 200 is inserted into the main body 110.

[0028] The protruding portion 220 is connected to the fitting portion 210 and protrudes from the insertion hole 110h of the connection body 100. The protruding portion 220 has a base end portion 222 and a connection portion 224.

[0029] The base end portion 222 extends from the fitting portion 210 along the central axis of the enclosure portion 112. The base end portion 222 has an attachment portion 222a, a protrusion 222b, and a reduced diameter portion 222c.

[0030] The mounting portion 222a is a portion to which the stopper 600 is attached. As shown in Figures 9 and 10, the mounting portion 222a has a cylindrical outer circumferential surface. The cylindrical outer circumferential surface may be continuous in the circumferential direction, or may have portions that are partially discontinuous in the circumferential direction.

[0031] The protrusion 222b protrudes radially from the outer circumferential surface of the mounting portion 222a. The protrusion 222b is provided at the tip of the mounting portion 222a. In this embodiment, the protrusion 222b is continuously connected in the circumferential direction.

[0032] The reduced diameter portion 222c connects the fitting portion 210 and the mounting portion 222a. The reduced diameter portion 222c gradually reduces in diameter from the tip of the fitting portion 210 toward the mounting portion 222a. The tip of the reduced diameter portion 222c and the mounting portion 222a are radially opposed to the enclosure portion 112. As shown in Figure 6, a radial gap S is formed between the enclosure portion 112 and the mounting portion 222a.

[0033] The connecting portion 224 extends from the base end portion 222 along the central axis of the enclosure portion 112. The tube 10 is connected to the connecting portion 224. As shown in FIG. 6 , the outer diameter of the base end portion 222 is larger than the outer diameter of the connecting portion 224.

[0034] The seal member 300 is disposed inside the connector 200. The seal member 300 is formed in a cylindrical shape. The seal member 300 constitutes part of the flow path FL. The seal member 300 is made of rubber or the like. As shown in FIG. 6 , before one of the pair of sterile connection units 2 is connected to the other sterile connection unit 2, the seal member 300 protrudes from the end face of the fitting portion 210.

[0035] The cover 400 is connected to the connecting body 100 so as to be rotatable relative to the connecting body 100. In this embodiment, the cover 400 has a hinge 410 (see FIGS. 1 to 3) that is rotatably connected to the main body 110. The cover 400 is rotatable about the hinge 410 relative to the main body 110 between a clamping position (the position shown in FIG. 1) in which the cover 400 and the sealing member 300 clamp the protective sheet 500, and an opening position (the position shown in FIG. 2) in which the protective sheet 500 is opened.

[0036] The protective sheet 500 protects the seal member 300. The protective sheet 500 is in contact with the seal member 300 so as to block the flow path FL. The protective sheet 500 is made of a nonwoven fabric or the like. One end of the protective sheet 500 is connected to the end surface of the fitting portion 210. The other end of the protective sheet 500 is connected to the cover 400.

[0037] The stopper 600 prevents the connector 200 from being removed from the connection body 100. The stopper 600 is attached to the attachment portion 222a of the connector 200. As shown in Figures 4, 6, and 9 to 11, the stopper 600 has a clamping portion 610, a flange 620, and a guided portion 630.

[0038] The clamping portion 610 clamps the mounting portion 222a. The clamping portion 610 has a cylindrical shape with a portion cut out. The clamping portion 610 has a protrusion abutting portion 612. The protrusion abutting portion 612 abuts against the protrusion 220 in a direction parallel to the axial direction of the protrusion 220. Specifically, the protrusion abutting portion 612 abuts against the protrusion 222b in a direction parallel to the axial direction. The protrusion abutting portion 612 is configured at the tip of the clamping portion 610 in the axial direction.

[0039] The flange 620 has a shape that protrudes radially from the base end of the clamping portion 610. The flange 620 has a main body abutment portion 622. The main body abutment portion 622 abuts against the connecting main body 100 in a direction parallel to the axial direction. Specifically, the main body abutment portion 622 abuts against the surrounding portion 112 in a direction parallel to the axial direction. The main body abutment portion 622 is formed on the back surface of the flange 620.

[0040] The guided portion 630 is connected to the flange 620. The guided portion 630 protrudes from the upper end of the flange 620 toward the opposite side from the side on which the clamping portion 610 is located, with the flange 620 as the reference.

[0041] The main body 110 has guide portions 114 that guide the guided portion 630. The guide portions 114 have a shape that extends in the radial direction of the protruding portion 220. The guide portions 114 are formed on both sides of the guided portion 630 in a direction parallel to the direction connecting the first connecting portion 120 and the second connecting portion 130.

[0042] Next, a method of using the sterile connection device 1 in this embodiment will be described with reference to Figures 12 to 15. Figures 12 to 15 show cross sections taken along a plane passing through the centers of the surrounding portion 112 and the connector 200.

[0043] In the initial state (state before use of the sterile connection device 1), as shown in FIG. 12, the cover 400 of each sterile connection unit 2 is in a clamping position.

[0044] Next, as shown in FIG. 13, the cover of each sterile connection unit 2 is placed in an open position.

[0045] 14, the pair of sterile connection units 2 are connected to each other. Specifically, the pair of sterile connection units 2 are brought close to each other so that the first coupling part 120 of one sterile connection unit 2 is connected to the second coupling part 130 of the other sterile connection unit 2, and the second coupling part 130 of one sterile connection unit 2 is connected to the first coupling part 120 of the other sterile connection unit 2.

[0046] At this time, the first claw portion 124 of one of the sterile connection units 2 climbs over the second claw portion 134 of the other of the sterile connection units 2 and engages with the second claw portion 134, and the first claw portion 124 of the other of the sterile connection units 2 climbs over the second claw portion 134 of one of the sterile connection units 2 and engages with the second claw portion 134.

[0047] This maintains the pair of sterile connection units 2 connected to each other, and each protective sheet 500 is sandwiched between the sealing member 300 in one sterile connection unit 2 and the sealing member 300 in the other sterile connection unit 2.

[0048] Finally, each cover 400 of the pair of sterile connection units 2 is pulled downward relative to the connection body 100. This causes the hinges 410 of each cover 400 to detach from the connection body 100, and the protective sheet 500 is removed together with each cover 400.

[0049] As a result, as shown in FIG. 15, the pair of seal members 300 come into close contact with each other, so that the flow path FL in one sterile connection unit 2 and the flow path FL in the other sterile connection unit 2 communicate with each other.

[0050] As described above, in the sterile connection device 1 of this embodiment, the connector 200 is configured as a separate member from the connection body 100, so it is possible to form the connection body 100 from a material that satisfies the functionality (e.g., strength) required of the connection body 100, and to form the connector 200 from a material that satisfies the functionality (e.g., resistance to liquids and stability) required of the connector 200. This increases the degree of freedom in selecting materials for the connection body 100 and the connector 200.

[0051] Furthermore, since this sterile connection device 1 is provided with the stopper 600 having the protrusion abutment portion 612 and the main body abutment portion 622, the removal of the connector 200 from the connection main body 100 is effectively restricted.

[0052] It will be appreciated by those skilled in the art that the exemplary embodiments described above are examples of the following aspects.

[0053] a seal member disposed inside the connector and constituting part of the flow path; a cover connected to the connection body; a protective sheet that contacts the seal member so as to close the flow path and protects the seal member; and a stopper that prevents the connector from being removed from the connection body; wherein the connector has a fitting portion that fits into the insertion hole of the connection body, and a protrusion that is connected to the fitting portion and protrudes from the insertion hole; and the stopper has a protrusion abutment portion that abuts the protrusion in a direction parallel to the axial direction of the protrusion, and a body abutment portion that abuts the connection body in a direction parallel to the axial direction.

[0054] In this sterile connection device, the connector is constructed as a separate member from the connection body, so it is possible to form the connection body from a material that satisfies the functionality required of the connection body (e.g., strength), and the connector from a material that satisfies the functionality required of the connector (e.g., resistance to liquids and stability), thereby increasing the freedom of material selection.

[0055] Furthermore, since this sterile connecting device is provided with a stopper having a protrusion abutting portion and a main body abutting portion, the connector is effectively prevented from being detached from the connecting main body.

[0056] [Aspect 2] The sterile connection device described in Aspect 1, wherein the protrusion has a base end extending from the fitting portion along the axial direction and a connection portion extending from the base end along the axial direction, and the outer diameter of the base end is larger than the outer diameter of the connection portion.

[0057] In this aspect, the rigidity of the base end portion of the connector is relatively high, so that damage to the connector when connecting a tube to the connection portion, etc., is suppressed.

[0058] [Aspect 3] The sterile connection device according to Aspect 2, wherein the connection body has an enclosing portion that annularly encloses a portion of the base end, and a gap is formed between the base end and the enclosing portion in the radial direction of the base end.

[0059] In this aspect, slight tilting of the protrusion relative to the connection body and the fitting portion is permitted, which more reliably prevents damage to the connector when connecting a tube to the connector, for example.

[0060] [Aspect 4] A sterile connection device according to any one of Aspects 1 to 3, wherein the stopper has a guided portion connected to the main body abutment portion, and the connection main body has a shape extending radially from the protrusion and a guide portion that guides the guided portion.

[0061] In this aspect, when the stopper is attached to the protruding portion in the radial direction of the protruding portion, the guided portion is effectively guided by the guiding portion.

[0062] [Aspect 5] The connection body has: a main body including the insertion hole; a first coupling part connected to the main body; and a second coupling part connected to the main body, wherein the first coupling part of one of the pair of sterile connection units is connectable to the second coupling part of the other of the pair of sterile connection units, and the second coupling part of one of the pair of sterile connection units is connectable to the first coupling part of the other of the pair of sterile connection units, the first coupling part having: a first wall part connected to the main body and extending in a direction parallel to the axial direction; and a first claw part formed at a tip of the first wall part, and the second coupling part having: a second wall part connected to the main body and extending in a direction parallel to the axial direction; and a second claw part connected to the second wall part, A sterile connection device as described in any one of aspects 1 to 4, wherein the second wall portion of one of the pair of sterile connection units has a shape that receives the first wall portion of the other of the pair of sterile connection units, the second claw portion of one of the pair of sterile connection units is engageable with the first claw portion of the other of the pair of sterile connection units, and the first wall portion is flexible.

[0063] [Aspect 6] The sterile connection device according to Aspect 1, wherein the cover is connected to the connection body so as to be rotatable relative to the connection body between a closed position in which the flow path is closed and an open position in which the flow path is opened.

[0064] It should be noted that the embodiments disclosed herein are illustrative in all respects and should not be considered limiting. The scope of the present invention is defined by the claims, not by the description of the above embodiments, and further includes all modifications within the meaning and scope of the claims.

[0065] 1 Sterile connection device, 2 Sterile connection unit, 100 Connection body, 110 Main body, 112 Enclosure portion, 114 Guide portion, 120 First coupling portion, 122 First wall portion, 124 First claw portion, 130 Second coupling portion, 132 Second wall portion, 134 Second claw portion, 200 Connector, 210 Fitting portion, 220 Protrusion portion, 222 Base end portion, 224 Connection portion, 300 Sealing member, 400 Cover, 500 Protective sheet, 600 Stopper, 610 Clamping portion, 612 Protrusion abutment portion, 620 Flange, 622 Body abutment portion, 630 Guided portion, FL Flow path.

Claims

1. A sterile connection device having a pair of sterile connection units connectable to each other, each of the sterile connection units comprising: a connection body having an insertion hole; a connector formed as a separate member from the connection body and inserted into the insertion hole of the connection body to form a fluid flow path; a sealing member disposed inside the connector and constituting part of the flow path; a cover connected to the connection body; a protective sheet in contact with the sealing member so as to close the flow path and to protect the sealing member; and a stopper which regulates removal of the connector from the connection body, wherein the connector has a fitting portion which fits into the insertion hole of the connection body and a protruding portion connected to the fitting portion and protruding from the insertion hole, and the stopper has a protruding portion abutting portion which abuts the protruding portion in a direction parallel to the axial direction of the protruding portion, and a main body abutting portion which abuts the connection body in a direction parallel to the axial direction.

2. The sterile connection device of claim 1, wherein the protrusion has a base end extending from the fitting portion along the axial direction and a connecting portion extending from the base end along the axial direction, and the outer diameter of the base end is larger than the outer diameter of the connecting portion.

3. A sterile connection device as described in claim 2, wherein the connection body has an enclosing portion that annularly encloses a portion of the base end, and a gap is formed between the base end and the enclosing portion in the radial direction of the base end.

4. A sterile connection device as described in claim 1, wherein the stopper has a guided portion connected to the main body abutment portion, and the connection main body has a shape extending radially from the protrusion and has a guide portion that guides the guided portion.

5. The connection body has: a main body including the insertion hole; a first coupling part connected to the main body; and a second coupling part connected to the main body, the first coupling part of one of the pair of sterile connection units being connectable to the second coupling part of the other of the pair of sterile connection units, and the second coupling part of one of the pair of sterile connection units being connectable to the first coupling part of the other of the pair of sterile connection units, the first coupling part having a first wall part connected to the main body and extending in a direction parallel to the axial direction, and a first claw part formed at a tip of the first wall part, the second coupling part having a second wall part connected to the main body and extending in a direction parallel to the axial direction, and a second claw part connected to the second wall part, The sterile connection device according to claim 1, wherein the second wall portion of one of the pair of sterile connection units has a shape to receive the first wall portion of the other of the pair of sterile connection units, the second claw portion of one of the pair of sterile connection units is engageable with the first claw portion of the other of the pair of sterile connection units, and the first wall portion is flexible.

6. A sterile connection device as described in claim 1, wherein the cover is connected to the connection body so as to be rotatable relative to the connection body between a closed position in which the flow path is blocked and an open position in which the flow path is opened.

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