Throw-away genderless sterile fluid coupling

Abstract

To provide a device, a system and a method improved for chemical administration.SOLUTION: Several fluid coupling devices described in the specification are constituted so as to be used in a fluid system. For example, several embodiments described in the specification are throw-away sterile fluid coupling devices bondable in order to make a sterile flow path passed thereby. Several such sterile couplings are genderless couplings in which the same two sterile couplings can be bonded together.SELECTED DRAWING: Figure 73

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 892,491, filed August 27, 2019, and U.S. Provisional Application No. 62 / 948,607, filed December 16, 2019. The disclosures of the prior applications are considered part of (and are incorporated by reference herein) the disclosure of this application. [Background technology]

[0002] The present invention relates to a fluid coupling device for fluid systems and methods. For example, some embodiments described herein relate to a single-use, sterile fluid coupling device.

[0003] Some fluid systems, such as some bioprocessing fluid systems or blood processing systems, may require fluid couplings that allow for sterile connection of fluid flow paths. In one example, it may be desirable to connect one or more sample bags to receive fluid samples from a bioreactor system in a manner that prevents contamination of the fluid sample. In that scenario, sterile couplings may be used to connect the sample bags to receive fluid from the bioreactor system while substantially preventing biological contamination of the fluid from the couplings and the environment. Summary of the Invention [Means for solving the problem]

[0004] This document describes several fluid coupling devices for fluid systems and methods. In some embodiments, the fluid coupling devices can be implemented as disposable sterile fluid coupling connection devices. In the context of this disclosure, the term "fluid" includes both gases and liquids.

[0005] In certain embodiments, the fluid coupling devices used herein are disposable devices because they are designed to resist uncoupling after the two portions of the coupling (also referred to herein as "coupling halves" and / or "connectors") are connected to one another. For example, such disposable coupling devices include one or more mechanical components that act like a lock to maintain the two portions of the coupling in a coupled state. Thus, in these certain embodiments, the fluid coupling devices provided herein are structurally configured to be disposable coupling devices, such that after the disposable coupling halves are connected to one another, they cannot be operatively separated from one another (e.g., to maintain the sterility or biological integrity of the system / fluid path / etc.).

[0006] Furthermore, in such disposable or other embodiments, the fluid coupling devices can be configured as "sterile" coupling devices that can be connected to one another while preventing the migration of biological contaminants into the fluid flow path. Such "sterile" couplings also help limit exposure of the fluid to the surrounding environment.

[0007] Furthermore, in such a disposable embodiment, or in other embodiments, the fluid coupling device can be configured as a genderless coupling, i.e., the two coupling portions can be designed exactly the same, without male or female coupling halves, as in many conventional fluid coupling designs.

[0008] In one aspect, the present disclosure is directed to a sterile fluid coupling and method of use. In some embodiments, such a sterile fluid coupling can include: (i) a main body defining a longitudinal axis, a bore, and a fluid flow path through the main body along the longitudinal axis; (ii) a seal member including a portion disposed within the bore and a portion extending from a front surface around the longitudinal axis; and (iii) a flexible membrane including a portion attached to the front surface around the seal member to prevent contaminants from entering the fluid flow path, the flexible membrane also including a terminal portion at an opposite end of the membrane compared to the portion attached to the front surface. The main body can include a front surface, a terminal portion at an opposite end of the main body compared to the front surface, an alignment post, and an alignment guide defining an interior space configured to slidably receive the alignment post of another sterile fluid coupling when the two sterile fluid couplings are mated together.

[0009] Such a sterile fluid coupling may optionally include one or more of the following features: The alignment post may extend parallel to the longitudinal axis. The membrane may be porous to allow air to pass through the membrane. The alignment post and alignment guide may each include a coupling feature whereby the alignment post locks to the engaged alignment guide and the alignment guide locks to the engaged alignment post. The coupling feature of the alignment post may include at least one groove. The coupling feature of the alignment guide may include at least one flexible locking member. The main body may include a termination member including a termination. The termination member may extend into the bore. The termination member may snap-engage with another portion of the main body. The termination member may be rotatable about the longitudinal axis relative to the other portion of the main body. The sterile fluid coupling may also include a seal disposed between the termination member and the other portion of the main body. The termination member may define a portion of the fluid flow path. The termination member may abut a seal member within the bore. The sterile fluid fitting may also include a protective cover releasably engageable with the main body, the protective cover capable of compressing the two layers of the membrane against the seal member while the protective cover is engaged with the main body, and the protective cover may define an opening aligned with the longitudinal axis while the protective cover is engaged with the main body.

[0010] In another aspect, the present disclosure is directed to a sterile fluid fitting comprising: a main body defining a longitudinal axis, a bore, a fluid flow path through the main body along the longitudinal axis, a seal member including a portion extending from a front surface, and a flexible membrane including a portion attached to the front surface around the seal member. The main body includes a front surface, an alignment post, and an alignment guide.

[0011] Such a sterile fluid coupling may optionally include one or more of the following features: The alignment guide may define an interior space configured to slidably receive an alignment post of another sterile fluid coupling when the two of the sterile fluid couplings are mated together. The centerline of the alignment post, the centerline of the alignment guide, and the longitudinal axis may all be coplanar. A bore may be between the alignment post and the alignment guide. In some embodiments, the distance between the longitudinal axis and the centerline of the alignment post is equal to the distance between the longitudinal axis and the centerline of the alignment guide.

[0012] In another aspect, the present disclosure relates to a sterile fluid coupling device comprising a main body, a cover slidably attached to the main body, a first seal between the cover and the main body, a second seal within the main body, a seal pusher slidably coupled to the main body and positioned to abut the second seal, and a locking ring threadedly engaged with the main body and rotatably coupled to the seal pusher.

[0013] In another aspect, the present disclosure relates to a sterile fluid coupling device comprising a main body defining a longitudinal axis, a seal within the main body, and a seal pusher movably coupled to the main body and positioned to abut the seal, the seal pusher having a seal pusher lever slidably coupled within a slot defined by the main body and a membrane removably coupled to a front surface of the main body, the slot defined by the main body extending at an acute angle to the longitudinal axis such that rotating the seal pusher relative to the main body pushes the seal along the longitudinal axis relative to the main body.

[0014] In another aspect, the present disclosure is directed to a sterile fluid coupling device including a main body and a seal disposed within the main body and having a pull tab integrally formed therewith, the main body including a piercing element positioned to pierce a portion of the seal or the pull tab.

[0015] In another aspect, the present disclosure is directed to a sterile fluid coupling device comprising a main body having at least a portion thereof an oval cross-sectional shape, a seal disposed within the main body, and an insert slidably coupled to the main body and slidable along a longitudinal axis of the main body between a first position and a second position, wherein movement of the insert from the first position to the second position causes the insert to penetrate the seal.

[0016] In another aspect, the present disclosure is directed to a sterile fluid coupling device comprising a seal body, a first seal within the seal body, a twist collar threadedly engaged with the seal body, and a plunger slidably coupled to the seal body and positioned to pierce the first seal in response to rotation of the twist collar relative to the seal body, the plunger having a second seal attached to a distal end thereof.

[0017] In another aspect, the present disclosure relates to a sterile fluid coupling device comprising: a main body defining a longitudinal axis; a seal within the main body; a seal pusher movably coupled to the main body and positioned to abut the seal, the seal pusher having a seal pusher lever having two radially extending portions slidably coupled within a slot defined by the main body; and a membrane removably coupled to a front surface of the main body and covering the seal. The slot defined by the main body extends at an acute angle to the longitudinal axis such that rotation of the seal pusher relative to the main body pushes the seal along the longitudinal axis relative to the main body.

[0018] Certain embodiments of the subject matter described herein may be implemented to achieve one or more of the following advantages: First, in some embodiments, the fluid coupling device may advantageously provide audible, visual, and / or tactile feedback to a user in connection with actions performed to physically connect two portions of the fluid coupling device to one another.

[0019] Second, some embodiments of the fluid coupling devices provided herein are metal-free (also referred to as non-metallic fluid coupling devices). Therefore, such embodiments of the non-metallic fluid coupling devices can be advantageously sterilized using gamma sterilization techniques. Additionally, in some circumstances, non-metallic fluid coupling devices exhibit enhanced fatigue resistance, minimal installation stress, and enhanced corrosion resistance compared to some fluid couplings that include traditional metal components, such as metal springs.

[0020] Third, some embodiments of the fluid coupling device provide improved sterile connection capabilities that can optionally reduce or eliminate the need for a sterile chamber or sterile benchtop environment in some cases. As such, these embodiments of the sterile fluid coupling device described herein can facilitate cost-effective operation or use that would otherwise be expensive or prohibitive in some conventional settings that require connection of certain fluid couplings within a sterile chamber or sterile flow hood to prevent biological contamination.

[0021] Fourth, some embodiments of the fluid coupling devices provided herein are advantageously designed to be genderless. Thus, use of the fluid coupling devices is simplified and users need to inventory less fluid coupling components. The genderless aspect of the fluid couplings also provides additional system flexibility, as one with one of these couplings can be connected to anything else.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Furthermore, the materials, methods, and examples of the embodiments described herein are illustrative only and are not intended to be limiting.

[0023] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a schematic diagram of an exemplary fluid system including exemplary fluid couplings arranged in a pre-coupled configuration, according to certain embodiments provided herein. [Figure 2] FIG. 2 is a perspective view of an exemplary sterile fitting according to some embodiments. [Figure 3] FIG. 3 is a plan view of the sterile fitting of FIG. [Figure 4] 4 is a longitudinal cross-sectional view of the sterile fitting of FIG. 2 taken along line 4-4 of FIG. [Figure 5] FIG. 5 is a perspective view of two of the sterile fittings of FIG. 2 in an uncoupled configuration. [Figure 6] FIG. 6 shows a longitudinal cross-sectional view of two of the sterile fittings of FIG. 2 in an uncoupled configuration. [Figure 7] FIG. 7 is a side view of the two sterile fittings of FIG. 2 in a pre-coupled configuration. [Figure 8] FIG. 8 is a perspective view of another exemplary sterile fitting according to some embodiments. [Figure 9] FIG. 9 is a side view of the sterile fitting of FIG. [Figure 10] 10 is a longitudinal cross-sectional view of the sterile fitting of FIG. 8 taken along line 10-10 of FIG. [Figure 11] FIG. 11 is a perspective view of the two sterile fittings of FIG. 8 in a pre-coupled configuration. [Figure 12] FIG. 12 is a side view of the two sterile fittings of FIG. 8 in a pre-coupled configuration. [Figure 13] 13 is a longitudinal cross-sectional view of the two sterile fittings of FIG. 8 in a pre-bonded configuration, taken along break line 13-13 of FIG. [Figure 14] FIG. 14 is a perspective view of another exemplary sterile fitting according to some embodiments. [Figure 15]FIG. 15 is a side view of the sterile fitting of FIG. [Figure 16] 16 is a longitudinal cross-sectional view of the sterile fitting of FIG. 14 taken along line 15-15 of FIG. [Figure 17] 17 is a perspective view of the seal and pull tab of the sterile fitting of FIG. 14. FIG. [Figure 18] 18 is a cross-sectional view of the seal and pull tab of FIG. [Figure 19] FIG. 19 shows a partial cross-sectional view of the seal and pull tab of FIG. [Figure 20] FIG. 20 is a perspective view of the two sterile fittings of FIG. 14 in a pre-coupled configuration. [Figure 21] FIG. 21 is a side view of the two sterile fittings of FIG. 14 in a pre-coupled configuration. [Figure 22] 22 is a longitudinal cross-sectional view of the two sterile fittings of FIG. 14 taken along the line 22-22 of FIG. [Figure 23] FIG. 23 is a perspective view of another exemplary sterile fitting according to some embodiments. [Figure 24] FIG. 24 is an end view of the sterile fitting of FIG. [Figure 25] 25 is a longitudinal cross-sectional view of the aseptic fitting of FIG. 23 taken along the line BB of FIG. 24. FIG. [Figure 26] FIG. 26 is a plan view of the sterile fitting of FIG. [Figure 27] 27 is a longitudinal cross-sectional view of the aseptic fitting of FIG. 23 taken along the line AA of FIG. [Figure 28] FIG. 28 is a side view of the sterile fitting of FIG. [Figure 29] 29 is a perspective view of the insert component of the sterile fitting of FIG. 23. FIG. [Figure 30] FIG. 30 is an end view of the insert piece of FIG. [Figure 31] 31 is a longitudinal cross-sectional view of the insert component of FIG. 29 taken along the break line BB of FIG. [Figure 32]32 is a first side view of the insert component of FIG. 29. FIG. [Figure 33] 33 is a second side view of the insert component of FIG. 29. FIG. [Figure 34] 34 is a perspective view of the sealing component of the sterile fitting of FIG. 23. FIG. [Figure 35] FIG. 35 is an end view of the seal component of FIG. [Figure 36] FIG. 36 is a side view of the seal component of FIG. [Figure 37] 37 is a first longitudinal cross-sectional view of the insert component of FIG. 34 taken along the line AA of FIG. [Figure 38] 38 is a second longitudinal cross-sectional view of the insert component of FIG. 34 taken along the break line BB of FIG. [Figure 39] FIG. 39 is a perspective view of the two sterile fittings of FIG. 23 in a pre-coupled configuration. [Figure 40] FIG. 40 is a side view of the two sterile fittings of FIG. 23 in a pre-coupled configuration. [Figure 41] FIG. 41 is an end view of the two sterile fittings of FIG. 23 in a pre-coupled configuration. [Figure 42] FIG. 42 is another side view of the two sterile fittings of FIG. 23 in a pre-coupled configuration. [Figure 43] 43 is a longitudinal cross-sectional view of the two sterile fittings of FIG. 23 in a pre-coupled configuration, taken along the break line AA of FIG. 41. FIG. [Figure 44] 44 is a longitudinal cross-sectional view of the two sterile fittings of FIG. 23 in a pre-coupled configuration along break line BB of FIG. 42. FIG. [Figure 45] FIG. 45 is a perspective view of another exemplary sterile fitting according to some embodiments. [Figure 46] FIG. 46 is an end view of the sterile fitting of FIG. [Figure 47] FIG. 47 is a first side view of the sterile fitting of FIG. [Figure 48]48 is a first longitudinal cross-sectional view of the sterile fitting of FIG. 45 taken along the line AA of FIG. [Figure 49] 49 is a second longitudinal cross-sectional view of the sterile fitting of FIG. 45 taken along the break line BB of FIG. 47. FIG. [Figure 50] FIG. 50 is a second side view of the sterile fitting of FIG. [Figure 51] 51 is an exploded longitudinal cross-sectional view of the plunger component and seal of the sterile fitting of FIG. 45. FIG. [Figure 52] 52 is a perspective view of the twist collar component of the sterile fitting of FIG. [Figure 53] 53 is a perspective view of the seal body component of the sterile fitting of FIG. [Figure 54] 54 is a perspective view of the sealing component of the sterile fitting of FIG. [Figure 55] FIG. 55 is a longitudinal cross-sectional view of the seal component of FIG. [Figure 56] FIG. 56 is a perspective view of the two sterile fittings of FIG. 45 in a pre-coupled configuration. [Figure 57] FIG. 57 is a first side view of the two sterile fittings of FIG. 45 in a pre-coupled configuration. [Figure 58] FIG. 58 is an end view of the two sterile fittings of FIG. 45 in a pre-coupled configuration. [Figure 59] FIG. 59 is a longitudinal cross-sectional view of the two sterile fittings of FIG. 45 in a pre-coupled configuration. [Figure 60] FIG. 60 is a second side view of the two sterile fittings of FIG. 45 in a pre-coupled configuration. [Figure 61] FIG. 61 is a side view of another exemplary sterile fitting according to some embodiments. [Figure 62] FIG. 62 is a plan view of the sterile fitting of FIG. [Figure 63] FIG. 63 is an end view of the sterile fitting of FIG. [Figure 64] FIG. 64 is a perspective view of the sterile fitting of FIG. [Figure 65] FIG. 65 is another perspective view of the sterile fitting of FIG. [Figure 66] FIG. 66 is a top view of the sterile fitting of FIG. 61 with the protective cover removed. [Figure 67] 67 is a longitudinal cross-sectional view of the aseptic fitting of FIG. 61 taken along the break line 67-67 of FIG. [Figure 68] FIG. 68 is an end view of the sterile fitting of FIG. 61 with the protective cover removed. [Figure 69] FIG. 69 is a plan view of the two sterile fittings of FIG. 61 in a mated configuration. [Figure 70] 70 is a longitudinal cross-sectional view of the two joined sterile fittings of FIG. 61 taken along the break line 70-70 of FIG. 69. FIG. [Figure 71] FIG. 71 is an end view of the two sterile fittings of FIG. 61 in a mated configuration. [Figure 72] 72 is a longitudinal cross-sectional view of the two joined sterile fittings of FIG. 61 taken along the break line 72-72 of FIG. 69. FIG. [Figure 73] FIG. 73 is a perspective view of another exemplary sterile fitting according to some embodiments. [Figure 74] FIG. 74 is a plan view of the aseptic fitting of FIG. [Figure 75] FIG. 75 is an end view of the sterile fitting of FIG. [Figure 76] FIG. 76 is a longitudinal cross-sectional view of the aseptic fitting of FIG. [Figure 77] FIG. 77 is a first perspective view of the sterile fitting of FIG. 73 without the protective cover. [Figure 78] FIG. 78 is another perspective view of the sterile fitting of FIG. 73 without the protective cover. [Figure 79] FIG. 79 is a plan view of the sterile fitting of FIG. 73 without the protective cover. [Figure 80] FIG. 80 is a bottom view of the sterile fitting of FIG. 73 without the protective cover. [Figure 81] FIG. 81 is an exploded view of the main body and membrane of the sterile fitting of FIG. [Figure 82] FIG. 82 is an exploded view of the main body of the sterile fitting of FIG. 73 showing the body member and end members separated from one another. [Figure 83] 83 is a side view of the sealing member of the sterile joint of FIG. 73. FIG. [Figure 84] FIG. 84 is an end view of the seal member of FIG. [Figure 85] FIG. 85 is a vertical cross-sectional view of the seal member of FIG. [Figure 86] FIG. 86 is a perspective view of the two sterile fittings of FIG. 73 in a mated configuration. [Figure 87] FIG. 87 is a plan view showing two of the sterile fittings of FIG. 73 in a mated configuration. [Figure 88] FIG. 88 is a vertical cross-sectional view taken along the line BB in FIG. [Figure 89] FIG. 89 is a vertical cross-sectional view taken along the line AA in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0025] Like numbers refer to corresponding parts throughout. As used herein, the term "sterilize" refers to a process that frees a surface area or volume from microorganisms to a particular extent. In exemplary embodiments, sterility of various components can be achieved using one or more sterilization techniques, including gamma irradiation, E-beam, ethylene oxide (EtO), and / or autoclave techniques.

[0026] As used herein, the term "aseptic" refers to any process that maintains a sterile surface or volume. As used herein, the term "fluid" means any substance that can be made to flow, including, but not limited to, liquids, gases, granular or powdered solids, mixtures or emulsions of two or more fluids, suspensions of solids in liquids or gases, etc.

[0027] 1, an exemplary system 10 is shown. System 10 includes a first piece of processing equipment 20 and a second piece of processing equipment 30. In the exemplary embodiment, processing equipment 20 and 30 are bioreactors containing biomaterial. In other embodiments, processing equipment 20 and 30 may be other devices requiring a sterile connection therebetween, such as, for example, a bioreactor and a media bag, sample bag, or other receptacle.

[0028] Processing device 20 includes a fluid pathway 22 extending therefrom that terminates in a sterile coupling device 50 that includes a first sterile coupling device 100a. Similarly, processing device 30 includes a fluid pathway 32 extending therefrom that terminates in a second sterile coupling device 100b of sterile coupling devices 50. Sterile coupling device 50 is representative of several different sterile couplings described herein.

[0029] In the exemplary embodiment, the sterile coupling devices 100a and 100b are substantially similar or genderless (e.g., identical except for possible differences in terminations), however, it should be noted that each sterile coupling device 100a, 100b can have different features than the other, if desired.

[0030] In exemplary embodiments, fluid pathways 22 and 32 and the fluid-containing environment within sterile coupling devices 100a and 100a are sterile. In some embodiments, sterile coupling device 50 can be arranged in an uncoupled configuration, one or more pre-coupled configurations, and a coupled configuration, as described further below. In the pre-coupled configuration, the coupling devices are mechanically coupled to one another, but no fluid flow path is open therethrough.

[0031] Coupling devices 100a and 100a are designed and configured such that they can be reconfigured from an uncoupled state to a coupled state (e.g., to couple fluid paths 22 and 32) while preventing loss of sterility of the fluid-containing environment within fluid paths 22 and 32. Thus, using sterile coupling device 50, fluid can be transferred between devices 20 and 30 (via coupling devices 100a and 100a) without bio-contamination.

[0032] 2-7 show a first exemplary sterile fitting 200. As shown in FIG. 7, two sterile fittings 200 can be mated together to create a sterile fitting device 300 through a sterile flow path.

[0033] The sterile fitting 200 includes a fitting part 210 and a cover 240. The fitting part 210 and the cover 240 are slidably coupled to one another (by a tongue-in-groove arrangement in the illustrated embodiment). A detent mechanism can removably lock the cover 240 to the fitting part 210. Once two sterile fittings 200 are mated together, either in a pre-coupled or coupled state, the covers 240 become disengaged from their respective fitting parts 210, as described further below.

[0034] A cover seal 216 (FIG. 4) is interposed between the cover 240 and the fitting portion 210. The cover 240 and cover seal 216 prevent contamination of the internal flow path of the sterile fitting 200 while the cover 240 is fitted to the fitting portion 210.

[0035] The coupling portion 210 includes a main body 212, a locking ring 220, a seal pusher 230, and a primary seal 236. The locking ring 220 is rotatably coupled to the seal pusher 230. The assembly of the locking ring 220 and the seal pusher 230 is threadably engaged with the main body 212. Thus, rotation of the locking ring 220 relative to the main body 212 causes the locking ring 220 and the seal pusher 230 to move longitudinally relative to the main body 212 in accordance with the pitch of the threads between the locking ring 220 and the main body 212. The seal pusher 230 is in contact with the primary seal 236.

[0036] While the sterile fitting 200 is in the unfitted configuration (as shown in Figures 2-6), the primary seal 236 is retracted from the front surface of the main body 212 facing the cover 240. Rotation of the locking ring 220 will translate the seal pusher 230 to push the primary seal 236 toward the front surface of the main body 212, allowing it to pass.

[0037] 5 and 6, the two sterile fittings 200 can be physically aligned with one another by a user in preparation for sliding them into a pre-fitted configuration. The main body 212 and cover 240 can include alignment ribs and corresponding alignment recesses to assist the user in properly aligning the two sterile fittings 200. Once the alignment ribs are positioned within the corresponding alignment recesses, the user can slide the fitting parts 210 (transverse to their longitudinal axes) into engagement with one another. In this process, the cover 240 is slid out of engagement with the fitting parts 210 and falls off.

[0038] After the fitting portions 210 are slid together, the fitting portions 210 of the two sterile fittings 200 are mated together as shown in Figure 7. A detent mechanism can releasably lock the two main bodies 212 together. Sliding the fitting portions 210 together places the sterile fittings 200 in a pre-bonded configuration. In this configuration, the primary seals 236 are not in contact with each other.

[0039] 7, with the two sterile fittings 200 in a pre-coupled configuration, the locking ring 220 of each fitting portion 210 can be rotated, causing the primary seals 236 to move toward and compress against each other. At this point, the two sterile fittings 200 are in the coupled configuration. A detent mechanism can lock the locking ring 220 in the coupled configuration.

[0040] Figures 8-13 show a second exemplary sterile fitting 400. As shown in Figures 11-13, two sterile fittings 400 can be mated together to create a sterile fitting device 500 having a sterile flow path therethrough.

[0041] Sterile fitting 400 includes a main body 410, a seal pusher 420, a seal 430, and a membrane 440. Seal pusher 420 is rotatably coupled to main body 410. Seal 430 is inside main body 410 and abutted by seal pusher 420. Membrane 440 is removably attached to the front of main body 410 to completely cover seal 430 and seal the interior of main body 410 from the ambient environment. In some embodiments, membrane 440 is ultrasonically welded, heat sealed, or glued to main body 420.

[0042] In the unbonded and pre-bonded configuration, the seal 430 is completely within the main body 410, i.e., the front surface of the seal 430 is recessed from the front surface of the main body 410 and the membrane 440.

[0043] The main body 420 includes an alignment post and an alignment guide that defines an open space shaped to correspond to the alignment post so that the alignment post from the mating coupling can be slidably received therein.

[0044] 11-13, a user can couple two sterile fittings 400 together by aligning their alignment posts and alignment guides and pushing them longitudinally into engagement with one another as shown. This is the pre-coupled configuration. In some embodiments, a locking mechanism can restrain the two sterile fittings 400 together.

[0045] Next, seal pusher levers 422 extending from the seal pushers 420 can be pivoted relative to their respective main bodies 410. While pivoting, the seal pusher levers 422 move within slots 412 defined by the main bodies 410. The slots 412 extend at an acute angle relative to the longitudinal axis of the main bodies 410. Thus, as the seal pushers 420 pivot, they also move along the longitudinal axis, pushing the seals 430 accordingly. Upon full rotation (e.g., in the range of 80°-100°), the seal pusher levers 422 are received within slots defined within the alignment posts. In some embodiments, the seal pusher levers 422 are locked into the slots defined within the alignment posts.

[0046] As the seal pusher lever 422 rotates, the seal 430 compresses or pinches the two membranes 440 that remain between the seals 430. In effect, four layers of membrane 440 are disposed between the two seals 430 as each membrane 440 is folded over on itself.

[0047] While the seal 430 compresses the four layers of membrane 440 between them, the membrane 440 is pulled laterally, as shown by arrow P in Figure 13. Due to the folds in the membrane 440, as the membrane 440 is pulled, it effectively rolls off the face of the main body 410 and the seals 430 then come into abutment with each other, thereby creating the joined configuration of the sterile coupling device 500.

[0048] 14-22 show a third exemplary sterile fitting 600. As shown in FIGS. 20-22, two sterile fittings 600 can be mated together to create a sterile fitting device 700 having a sterile flow path therethrough.

[0049] Sterile fitting 600 includes a main body 610 and a seal / pull tab 620. Main body 610 includes a piercing member 612 (FIG. 21). Seal / pull tab 620 includes a seal member 622 and a pull tab 624 attached to one another. In some embodiments, seal / pull tab 620 is a unitary member. In some embodiments, seal / pull tab 620 is a unitary molded silicone member.

[0050] 20-22, a user can couple two sterile fittings 600 together by aligning their alignment posts and alignment guides and pushing them longitudinally into engagement with one another as shown. This is the pre-coupled configuration. In some embodiments, a locking mechanism can restrain the two sterile fittings 600 together.

[0051] Further compression of the two sterile fittings 600 toward one another causes the piercing member 612 to pierce and / or shear the seal / pull tab 620. The pull tab 624 can then be pulled in the direction of arrow P, causing it to be removed from the sterile fitting device 700 while the seal member 622 remains, and they abut each other.

[0052] Figures 23-44 show a fourth exemplary sterile fitting 800. As shown in Figures 39-44, two sterile fittings 800 can be mated together to create a sterile fitting device 900 having a sterile flow path therethrough.

[0053] Sterile fitting 800 includes a main body 810, an insert 820, and a seal 830. Seal 830 is fixedly coupled within main body 810. Insert 820 is movably coupled relative to main body 810 and seal 830.

[0054] The main body 810 has an oval cross-sectional shape. When a user compresses the main body 810 along the longitudinal axis of the oval cross-sectional shape, the insert 820 is translatable along the longitudinal axis of the main body 810. In some embodiments, simply pushing the insert 820 into the main body 810 causes the main body 810 to deflect, allowing the insert 820 to move further into the main body 810. The insert 820 has two detent positions relative to the main body 810: (i) a first position as shown, and (ii) a second position that creates a mating configuration of the two sterile fittings 800.

[0055] As the insert 820 moves further into the main body 810, the leading edge of the insert 820 contacts and penetrates the seal 830. The seal 830 can be perforated to allow it to be penetrated more easily than if it were not penetrated.

[0056] 39-33, a user can couple two sterile fittings 800 together by aligning their alignment posts and alignment guides and compressing them longitudinally into engagement with one another as shown. This is the pre-coupled configuration. In some embodiments, a locking mechanism can restrain the two sterile fittings 800 together.

[0057] While the two sterile fittings 800 are mated together, the user may advance the inserts 820 into the main body 810 (to their second position). In doing so, the seals 830 are pierced. Once the seals 830 are pierced, portions of the opposing seals 830 are displaced into contact with each other, forming a fluid seal therebetween. The tips of the inserts 820 are spaced apart from each other, and the seals 830 contact each other to establish a sealed, sterile flow path through the sterile fitting device 900. This is the mated configuration.

[0058] 45-60 show a fifth exemplary sterile fitting 1000. As shown in Figures 56-60, two sterile fittings 1000 can be mated together to create a sterile fitting device 1100 having a sterile flow path therethrough.

[0059] The sterile fitting 1000 includes a twist collar 1010, a seal body 1020, a plunger 1030, and a seal 1040. The seal 1040 is fixedly coupled within the seal body 1020. The twist collar 1010 threadably engages the seal body 1020. When the twist collar 1010 is rotated relative to the seal body 1020, the twist collar 1010 drives the plunger 1030 toward the seal 1040.

[0060] 56-60, a user can couple two sterile fittings 1000 together by aligning their alignment posts and alignment guides and pushing them longitudinally into engagement with one another as shown. This is the pre-coupled configuration. In some embodiments, a locking mechanism can restrain the two sterile fittings 1000 together.

[0061] The user can then rotate the twist collars 1010 relative to their respective seal bodies 1020. The rotation drives the plungers 1030 toward the seals 1040, causing the tips of the plungers 1030 to penetrate the seals 1040. In some embodiments, the seals 1040 include perforations (e.g., the plus sign "+" pattern in FIG. 54) to facilitate piercing of the plunger 1030. The plungers 1030 include tip seals 1032 (FIG. 51). When the plunger 1030 penetrates the seals 1040, the tip seals 1032 can abut against each other to form a sterile coupling device 1100 having a sterile flow path.

[0062] Figures 61-68 show another exemplary sterile fitting 1200. As shown in Figures 69-72, two sterile fittings 1200 can be mated together to create a sterile fitting device 1300 having a sterile flow path therethrough.

[0063] As shown in Figures 61-63, the protective cover 1202 can be removably attached to the main body 1210 of the sterile fitting 1200. The protective cover 1202 can serve to protect the membrane 1240 (not visible) during shipping and handling. The protective cover 1202 also maintains the rotational position of the seal pusher lever 1222, which extends through an open-ended slot 1203 defined by the protective cover 1202. Additionally, the presence of the protective cover 1202 can help facilitate manual handling of the sterile fitting 1200.

[0064] In the illustrated embodiment, the protective cover 1202 includes a first gripping portion 1204a and a second gripping portion 1204b on opposite sides of the protective cover 1202. To remove the protective cover 1202 from the sterile fitting 1200, a user can manually pinch the gripping portions 1204a-b toward each other to release opposite ends of the protective cover 1202 and then pull the protective cover 1202 longitudinally away from the sterile fitting 1200.

[0065] Once the protective cover 1202 is removed, the sterile fitting 1200 is fully visible, as shown in Figures 64-68.

[0066] The sterile fitting 1200 includes a main body 1210, a seal pusher 1220 having a radially extending seal pusher lever 1222, a seal 1230, and a membrane 1240. The seal pusher 1220 is rotatably coupled to the main body 1210. The seal pusher lever 1222 includes a first radially extending member 1223a and a second radially extending member 1223b.

[0067] Seal 1230 resides within main body 1210 and is abutted by seal pusher 1220. Membrane 1240 completely covers seal 1230 and is removably attached to the front of main body 1210 to seal the interior of main body 1210 from the ambient environment. In some embodiments, membrane 1240 is ultrasonically welded, heat sealed, or glued to main body 1220.

[0068] In some embodiments, while the sterile fitting 1200 is in the uncoupled and pre-coupled configuration, the seal 1230 is completely within the main body 1210. That is, the front surface of the seal 1230 is recessed from the front surface of the main body 1210 and from the membrane 1240. Alternatively, in some embodiments, the seal 1230 protrudes slightly from the front surface of the main body 1210 while the sterile fitting 1200 is in the uncoupled and pre-coupled configuration.

[0069] Main body 1210 includes alignment post 1212 and alignment guide 1216. Alignment guide 1216 defines an open space shaped in a manner corresponding to alignment post 1212 such that alignment post 1212 from a mating sterile fitting 1200 can be slidably received therein. Alignment post 1212 defines a notch 1213 and a lateral groove 1214. A free end of alignment post 1212 includes a locking member 1215. Alignment guide 1216 includes a locking member 1217 that extends radially into the open space defined by alignment guide 1216, as shown in FIG. 66 .

[0070] 69-72, a user can couple two sterile fittings 1200 together by aligning the alignment posts 1212 of a first one of the sterile fittings 1200 with the alignment guides 1216 of a second one of the sterile fittings 1200 (and aligning the alignment guides 1216 of the first one of the sterile fittings 1210 with the alignment posts 1212 of the second one of the sterile fittings 1200), and then press them longitudinally into engagement with each other as shown to form the sterile fitting device 1300. Once the two sterile fittings 1200 are fully pressed together, the locking members 1217 engage the notches 1213, longitudinally separating the two sterile fittings 400 together. This is the first pre-coupled configuration.

[0071] Next, seal pusher levers 1222 extending from the seal pushers 1220 may be pivoted relative to their respective main bodies 1210. While pivoting, the seal pusher levers 1222 move within slots 1211 defined by the main bodies 1210. The slots 1211 extend at an acute angle relative to the longitudinal axis of the main bodies 1210. Thus, as the seal pushers 1220 pivot, they also move along the longitudinal axis, correspondingly pushing the seals 1230 toward the mated sterile fitting 1200. Upon full rotation (e.g., in the range of 80°-100°), the seal pusher levers 1222 are received by the alignment posts 1212. In particular, first radially extending member 1223a is received within lateral groove 1214 and second radially extending member 1223b is engaged by locking member 1215, locking seal pusher 1220 in an orientation where seals 1230 are pressed together (with membrane 1240 therebetween). This is the second pre-coupled configuration.

[0072] As the seal pusher lever 1222 rotates, the seal 1230 compresses or pinches the two membranes 1240 that remain between the seals 1230. In effect, four layers of membrane 1240 are disposed between the two seals 1230 as each of the membranes 1240 is folded over on itself.

[0073] While the seal 1230 compresses the four layers of membrane 1240 between them, the membrane 1240 can be pulled laterally away from the sterile fitting 1200. Due to the folds in the membrane 1240, as the membrane 1240 is pulled, it effectively rolls off the face of the main body 1210 and the seals 1230 then come into abutment with each other. This creates the bonded configuration of the sterile fitting device 1300.

[0074] Figures 73-89 show another exemplary sterile fitting 1400. The sterile fitting 1400 is a genderless fitting, i.e., as shown in Figures 86-89. Two sterile fittings 1400 can be mated together to create a sterile fitting device 1500 having a sterile flow path therethrough (sterile flow path 1501 along the longitudinal axis of the sterile fitting 1400, Figure 89).

[0075] As shown in FIGS. 73-76 , the protective cover 1402 can be removably attached to the main body 1410 of the sterile fitting 1400. The protective cover 1402 can serve to protect the membrane 1440 during shipping and handling. The protective cover 1402 also abuts the membrane 1440 (i.e., two layers of the membrane 1440 as shown in FIG. 76 ), where the membrane 1440 is adjacent the front surface of the main body 1410. Thus, the protective cover 1402 serves to support or reinforce the attachment of the membrane 1440 to the front surface of the main body 1410 around the seal 1430. This reinforcement can be beneficial, for example, because during sterilization, the sterile fitting 1440 can be exposed to heat and / or pressure changes that can tend to stress the bond between the membrane 1440 and the main body 1410. The protective cover 1402 defines an opening 1406 that is aligned with the longitudinal axis and fluid flow path of the main body 1410. Additionally, the presence of the protective cover 1402 can help facilitate manual manipulation of the sterile fitting 1400.

[0076] In the illustrated embodiment, the protective cover 1402 includes a first grip portion 1404a and a second grip portion 1404b on opposite sides of the protective cover 1402. To remove the protective cover 1402 from the main body 1410, a user can manually pinch the grip portions 1404a-b toward each other to release opposite ends of the protective cover 1402 and then pull the protective cover 1402 longitudinally away from the main body 1410. Once the protective cover 1402 is removed, the main body 1410 and membrane 1440 are fully visible, as shown in FIGS. 77-81.

[0077] 77-81 show various views of the main body 1410 and membrane 1440. The membrane 1440 is removably attached to the main body 1410. The membrane 1440 completely covers the seal 1430 (FIG. 76) and is removably attached to the front of the main body 1410 to seal the interior of the main body 1410 from the ambient environment. In some embodiments, the membrane 1440 is ultrasonically welded, heat sealed, glued, or otherwise removably attached to the main body 1420.

[0078] Membrane 1440 is a thin, flexible member. Membrane 1440 can be made from materials such as, but not limited to, polyethersulfone (PES), non-woven polyethylene such as Tyvek®, PES and polyester laminates, expanded polytetrafluoroethylene (ePTFE), metal foil, and the like, and combinations thereof. In some embodiments, membrane 1440 is hydrophobic and breathable. In certain embodiments, the pore size of membrane 1440 is such that microorganisms larger than 0.2 microns are filtered out.

[0079] The membrane 1440 includes a fold 1442 and an end portion 1444. As described further below, when two sterile fittings 1400 are mated together in a pre-bonded configuration, the membrane 1440 is then manually removed to create an open flow path through the two bonded sterile fittings 1400 (this is referred to as the bonded configuration).

[0080] When two sterile fittings 1400 are mated together in a pre-attached configuration, the terminal portions 1444 of the two flexible membranes 1440 can be manually manipulated to abut one another. The membranes 1440 can then be removed from the pre-attached sterile fittings 1400 by pulling on the terminal portions 1444 of the membranes 1440. That is, a user can manually grasp the terminal portions 1444 of the two membranes 1440 (e.g., grasp both terminal portions 1444 simultaneously) and simultaneously pull the membranes 1440 laterally away from the longitudinal axes of the two sterile fittings 1400. As the membranes 1440 are pulled laterally away from the longitudinal axes of the two sterile fittings 1400, the folds 1442 progress in the lateral direction of the pull by rolling. This rotation of the fold 1442 removes the membrane 1440 from the front faces of the two sterile fittings 1400. Once the membrane 1440 is removed from the front faces, the seals 1430 eventually contact each other, forming a sterile flow path through the two sterile fittings 1400.

[0081] 82, the main body 1410 may optionally be of two-piece construction, i.e., in the illustrated embodiment, the main body 1410 includes a body 1450 and an end member 1460. A seal 1462 (FIG. 76) may be disposed between the body 1450 and the end member 1460 to provide a fluid-tight structure.

[0082] In the illustrated embodiment, the end member 1460 is conveniently snapped into engagement with the body 1450. That is, the body 1450 includes two locking members 1451 a and 1451 b, each of which engages a circumferential groove 1461 in the end member 1460 to longitudinally restrain the body 1450 and the end member 1460 together. This snap-in arrangement improves efficiency when deploying the sterile fitting 1400 with various types of end members 1460 (e.g., a barb connection as shown, a threaded connection, an elbow fitting, a tee fitting, a compression fitting, etc.). In the illustrated embodiment, the end member 1460 is rotatable about its longitudinal axis relative to the body 1450. In other words, the end member 1460 can pivot relative to the body 1450. In some embodiments, the end member 1460 is configured to prevent pivoting (eg, by using flats or keyways at the connection between the end member 1460 and the body 1450).

[0083] 83-85 show an exemplary seal 1430. The seal 1430 (shown here in isolation) is positioned within a central bore defined by the body 1450 (FIG. 76) such that the leading edge of the seal 1430 (while covered by the membrane 1440) protrudes slightly beyond the front surface of the body 1450. In some embodiments, the other end of the seal 1430 and an end of the termination member 1460 abut each other within the bore of the body 1450 (FIG. 76).

[0084] In the illustrated embodiment, the seal 1430 defines a central longitudinal bore 1431. The outer diameter of the seal 1430 includes a first cylindrical tip 1432, a second cylindrical tip 1435, and a waist between the tips 1432 and 1435. The outer diameter of the waist is smaller than the outer diameter of the cylindrical tips 1432 and 1435 and includes a cylindrical portion 1433 and a frusto-conical portion 1434. The bore 1431 includes two cylindrical tips and a central portion (between the cylindrical tips) that is an oval segment (with its tips truncated). In some embodiments, the waist of the seal 1430 outer diameter is arc-shaped (rather than having a cylindrical portion 1433 and a frusto-conical portion 1434). In such cases, the center of the arc of the outer diameter is located in the opposite direction from the center of the arc of the inner central portion. In some such embodiments, the arc radii of the arc of the outer diameter and the arc of the inner central portion are unequal. In some such embodiments, the arc radius of the outer diameter and the arc radius of the inner central portion are equal.

[0085] Figures 86-89 show two sterile fittings 1400 joined together to form a sterile fitting device 1500 with a sterile flow path 1501 therethrough. These figures show two sterile fittings 1400 joined together after removal of membrane 1440 (Figures 76-81). In some embodiments, the sequence of events for creating the sterile coupling device 1500 is to (i) remove the protective cover 1402 from the two sterile couplings 1400, (ii) snap the sterile couplings 1400 together so that a portion of the membrane 1440 is compressed between the two seals 1430 of the sterile couplings 1400 (this is the pre-coupled configuration), and (iii) manually pull the membrane 1440 laterally from the main body 1410 so that the two seals 1430 of the sterile coupling 1400 are exposed and pressed against each other (this is the actuated, coupled configuration) (see, for example, FIG. 89).

[0086] Each sterile fitting 1400 includes an alignment post 1412 and an alignment guide 1416 (see, e.g., Figures 77 and 78). The alignment guide 1416 defines an interior space configured to slidably receive the alignment post 1412 of another sterile fitting 1400. When two sterile fittings 1400 are coupled together to create a sterile fitting device 1500 (in both / either the pre-coupled configuration and the coupled configuration), the alignment post 1412 of a first one of the sterile fittings 1400 is engaged within the alignment guide 1416 of the second one of the sterile fittings 1400, and the alignment post 1412 of the second one of the sterile fittings 1400 is engaged within the alignment guide 1416 of the first one of the sterile fittings 1400.

[0087] Each alignment guide 1416 includes one or more flexible locking members 1417 (see, e.g., FIGS. 77 and 78). Each alignment post 1412 includes one or more notches 1413 that respectively receive the locking members 1417 of the mating fitting 1400. In the illustrated embodiment, each alignment guide 1416 includes two flexible locking members 1417, and each alignment post 1412 includes two notches 1413.

[0088] In the illustrated embodiment, the centerlines of the alignment post 1412, the alignment guide 1416, and the central fluid channel of the main body 1410 all lie in the same plane. The central fluid channel of the main body 1410 is between the alignment post 1412 and the alignment guide 1416.

[0089] To create the sterile coupling device 1500 shown in FIGS. 86-89, the user engages the alignment posts 1412 with the alignment guides 1416 of the two sterile couplings 1400. The locking members 1417 fit into the notches 1413. This is the pre-bonded configuration. The membrane 1440 is still attached and compressed between the tips of the seals 1430. The user then peels the membrane 1440 away from the front of the main body 1410. The face edges of the seals 1430 then contact each other. This is the operative bonded configuration. No further compression between the seals 1430 is necessary. The bonding process simply involves engaging two sterile couplings 1400 with each other and then removing the membranes 1440. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or what may be claimed, but rather as descriptions of features that may be unique to particular embodiments of a particular invention. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, while features may be described herein as operating in a certain combination and may initially be claimed as such, one or more features from a claimed combination may optionally be deleted from that combination, and the claimed combination may be directed to a subcombination or variation of the subcombination.

[0090] Similarly, while operations are shown in the figures in a particular order, this should not be understood as requiring such operations to be performed in the particular order shown, or in any sequential order, or that all of the operations shown be performed, to achieve desirable results. In certain situations, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the program components and systems described may generally be integrated together in a single product or packaged in multiple products.

[0091] Specific embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As an example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In some implementations, multitasking and parallel processing may be advantageous. The present invention has the following aspects (configurations). [Aspect 1] A sterile fluid coupling comprising: a main body defining a longitudinal axis, a bore, and a fluid flow path through the main body along the longitudinal axis, the main body comprising: The front and a terminal end at an opposite end of the main body relative to the front surface; An alignment post; an alignment guide defining an interior space configured to slidably receive an alignment post of another sterile fluid fitting when the two sterile fluid fittings are mated together; a seal member having a portion disposed within the bore and a portion extending from the front surface about the longitudinal axis; a flexible membrane attached to the front surface around the sealing member and having a portion that prevents contaminants from entering the fluid flow path, the flexible membrane including a termination portion at an opposite end of the flexible membrane from the portion attached to the front surface; A sterile fluid coupling comprising: [Aspect 2] 2. The sterile fluid fitting of claim 1, wherein the alignment posts extend parallel to the longitudinal axis. [Aspect 3] 3. The sterile fluid fitting of claim 1 or 2, wherein the flexible membrane is porous to allow air to pass through the flexible membrane. [Aspect 4] A sterile fluid fitting as described in any one of aspects 1 to 3, wherein each of the alignment posts and the alignment guides has a coupling feature, the alignment post locks to the engaged alignment guide, and the alignment guide locks to the engaged alignment post. [Aspect 5] 5. The sterile fluid fitting of claim 4, wherein the interlocking feature of the alignment post includes at least one groove. [Aspect 6] A sterile fluid fitting as described in aspect 4, wherein the coupling feature of the alignment guide has at least one flexible locking member. [Aspect 7] Aspect 7. The sterile fluid fitting of any one of aspects 1 to 6, wherein the main body includes an end member including the end portion, the end member extending into the bore. [Aspect 8] 8. The sterile fluid fitting of claim 7, wherein the end member snaps into engagement with the remainder of the main body. [Aspect 9] 9. A sterile fluid fitting according to claim 8, wherein the end member is rotatable about the longitudinal axis relative to the remainder of the main body. [Aspect 10] 10. The sterile fluid fitting of aspect 8 or 9, further comprising a seal disposed between the end member and the other portion of the main body. [Aspect 11] 11. The aseptic fluid coupling according to any one of aspects 7 to 10, wherein the terminating member defines a portion of the fluid flow path. [Aspect 12] 12. The sterile fluid coupling according to any one of aspects 7 to 11, wherein the end member abuts against the sealing member within the hole. [Aspect 13] Aspect 13. The sterile fluid fitting of any one of aspects 1-12, further comprising a protective cover releasably engageable with the main body. [Aspect 14] Aspect 14. The sterile fluid fitting of aspect 13, wherein the protective cover presses the two layers of the flexible membrane against the seal member while the protective cover is engaged with the main body. [Aspect 15] 15. The sterile fluid fitting of aspect 13 or 14, wherein the protective cover defines an opening aligned with the longitudinal axis while the protective cover is engaged with the main body. [Aspect 16] A sterile fluid coupling comprising: a main body defining a longitudinal axis, a bore, and a fluid flow path through the main body along the longitudinal axis, the main body comprising: The front and An alignment post; a main body having an alignment guide; a seal member having a portion extending from the front surface; a flexible membrane having a portion attached to the front surface around the seal member; A sterile fluid coupling comprising: [Aspect 17] A sterile fluid fitting as described in aspect 16, wherein when the two sterile fluid fittings are mated, the alignment guide defines an internal space configured to slidably receive an alignment post of the other sterile fluid fitting. [Aspect 18] Aspect 16 or 17, wherein the centerline of the alignment post, the centerline of the alignment guide, and the longitudinal axis are all in the same plane. [Aspect 19] 19. The sterile fluid fitting of claim 18, wherein the hole is between the alignment post and the alignment guide. [Aspect 20] Aspect 20. The sterile fluid fitting of aspect 18 or 19, wherein the distance between the longitudinal axis and the centerline of the alignment post is equal to the distance between the longitudinal axis and the centerline of the alignment guide. [Aspect 21] 1. A sterile fluid coupling device comprising: The main body and a cover slidably attached to the main body; a first seal between the cover and the main body; a second seal within the main body; and a seal pusher slidably coupled to the main body and positioned to abut the second seal; a locking ring threadably engaged with the main body and rotatably coupled to the seal pusher; A sterile fluid coupling device comprising: [Aspect 22] 1. A sterile fluid coupling device comprising: a main body defining a longitudinal axis; a seal within the main body; and a seal pusher movably coupled to the main body and positioned to abut the seal, the seal pusher having a seal pusher lever slidably coupled within a slot defined by the main body; a membrane removably coupled to a front surface of the main body; The slot defined by the main body extends at an acute angle to a longitudinal axis such that rotation of the seal pusher relative to the main body pushes the seal along the longitudinal axis relative to the main body. [Aspect 23] 1. A sterile fluid coupling device comprising: The main body and a seal disposed within the main body and having a pull tab integrally formed with the main body; The sterile fluid coupling device, wherein the main body includes a piercing element positioned to pierce a portion of the seal or the pull tab. [Aspect 24] 1. A sterile fluid coupling device comprising: a main body having at least a portion thereof an oval cross-sectional shape; a seal disposed in the main body; an insert slidably coupled to the main body and slidable along a longitudinal axis of the main body between a first position and a second position; A sterile fluid coupling device, wherein moving the insert from the first position to the second position causes the insert to pierce the seal. [Aspect 25] 1. A sterile fluid coupling device comprising: A seal body; a first seal within the seal body; and a twist collar threadedly engaged with the seal body; a plunger slidably coupled to the seal body and positioned to pierce the first seal in response to rotation of the twist collar relative to the seal body; The plunger has a second seal attached to the tip of the plunger. [Aspect 26] 1. A sterile fluid coupling device comprising: a main body defining a longitudinal axis; a seal within the main body; a seal pusher movably coupled to the main body and positioned to abut the seal, the seal pusher having a seal pusher lever having two slidably radially extending portions, the seal pusher lever slidably coupled within a slot defined by the main body; a membrane removably coupled to a front surface of the main body and covering the seal; The slot defined by the main body extends at an acute angle to the longitudinal axis such that rotation of the seal pusher relative to the main body pushes the seal along the longitudinal axis relative to the main body.

Claims

1. A sterile fluid coupling comprising: a main body defining a longitudinal axis and a bore, the main body comprising: The front and a terminal end at an opposite end of the main body relative to the front surface; An alignment post; an alignment guide defining an interior space configured to slidably receive an alignment post of another sterile fluid fitting when the two sterile fluid fittings are mated together; a seal member including a width along the longitudinal axis between a first end and a second end, the seal member having a portion disposed within the bore and a portion extending from the front surface around the longitudinal axis; a flexible membrane attached to the front surface around the sealing member and having a portion that prevents contaminants from entering the fluid flow path, the flexible membrane including a termination portion at an opposite end of the flexible membrane from the portion attached to the front surface; Equipped with the fluid flow path is defined through the sterile fluid fitting; a portion of the fluid flow path is defined by the flexible membrane along the entire width of the flexible membrane; each of the alignment posts and the alignment guides has a coupling feature, the alignment posts locking the engaged alignment guides and the alignment guides locking the engaged alignment posts; the interlocking feature of the alignment guide comprises at least one flexible locking member; the portion of the front surface to which the flexible membrane is attached is coplanar with the portion of the front surface from which the alignment posts extend; the centerline (i) of the alignment post, the centerline (ii) of the single alignment guide, and the longitudinal axis (iii) of the main body are in the same plane; Sterile fluid fittings.

2. The sterile fluid coupling of claim 1 , wherein the alignment posts extend parallel to the longitudinal axis.

3. 3. A sterile fluid coupling according to claim 1 or 2, wherein the flexible membrane is porous to allow air to pass through the flexible membrane.

4. The sterile fluid coupling of claim 1 , wherein the interlocking feature of the alignment post includes at least one groove.

5. 2. The sterile fluid coupling of claim 1, wherein the main body includes a terminal member including the terminus, the terminal member extending into the bore.

6. 6. The sterile fluid coupling of claim 5, wherein the end members snap-fit ​​with the remainder of the main body.

7. 7. The sterile fluid coupling of claim 6, wherein the end member is rotatable about the longitudinal axis relative to the remainder of the main body.

8. 7. The sterile fluid coupling of claim 6, further comprising a seal disposed between the end member and the other portion of the main body.

9. 6. The sterile fluid coupling of claim 5, wherein the terminating member defines a portion of the fluid flow path.

10. 6. The sterile fluid coupling of claim 5, wherein the end member abuts the sealing member within the bore.

11. 10. The sterile fluid coupling of claim 1, further comprising a protective cover releasably engageable with the main body.

12. 12. The sterile fluid coupling of claim 11, wherein the protective cover presses the two layers of the flexible membrane against the seal member while the protective cover is engaged with the main body.

13. 12. The sterile fluid coupling of claim 11, wherein the protective cover defines an opening aligned with the longitudinal axis while the protective cover is engaged with the main body.

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