Connector assembly for conduction of medical liquids

Abstract

The present application proposes a connector assembly (100) for communication of medical liquids, comprising an attachment part (1) for removably engaging a delivery device, a connection part (2) for connecting a container, and a flexible sealing member (3) circumferentially enclosed between the attachment part (1) and connection part (2) around a main axis (A). The sealing member (3) comprises a cylindrical body (30) extending along the axis (A) and a sealing head (31) at an axially distal end of the sealing member (3) with regard to the body (30). The sealing member (3) is arranged to have a closed first state in which the head (31) is received into an access opening (11) of the attachment part, and an open second state in which the head (31) is retracted away from the access opening (11) when compressed through the access opening (11) along the axis (A). The sealing member (3) further comprises one or more columns (33) on a side surface of the body (30); the columns (33) radially protruding away from the axis (A), and extending parallel to the axis (A) along the body (30). The columns (33) are sized and shaped for, when in the first state, maintaining a positive value of distance to respective one or more axially opposing inner surfaces (12) of the attachment part (1).

Description

[0001] CONNECTOR ASSEMBLY FOR CONDUCTION OF MEDICAL LIQUIDS

[0002] Technical Field

[0003] The present application relates to a connector assembly for communication of medical liquids. In particular, the present application relates to such an assembly according to the preamble of claim 1.

[0004] Background

[0005] Connectors for medical liquids such as swabbable needle-free connector assemblies are used for communicating medical liquids between a delivery device and a container of a further medium in hydraulic communication with the assembly. Examples to the container of further medium include a vial, bottle, ampule, flexible bag or intravenous catheter.

[0006] TR 2009 / 06911 discloses a swabbable needle-free connector assembly that includes an attachment part for being removably engaged with a delivery device, a connection part for being connected to a container of a further medium, and a flexible sealing member enclosed between the attachment part and connection part. The sealing member has a sealing head with a slot opening that is accessible through an access opening on the attachment part. In a normal, closed first state, the sealing head extends into the access opening which circumferentially supports the sealing head around a main axis of the assembly. In the first state, the slot opening is closed, thereby hermetically sealing a further medium-side thereof from a delivery device-side.

[0007] When a delivery device is introduced through the access opening and forced onto the sealing head along the main axis, axial compression of the sealing member results in radial expansion thereof, and the slot opening receives a tip of the delivery device. Thus, an open second state takes place, in which the sealing is ceased and fluid communication to or from the further medium-side is established. A flattened upper surface is not sufficient to ensure that the collapsed sealing member will return to its closed position with. If the sealing member remains logged inside even upon cessation of axial compression, the fluid path does not close, the medical fluid such as a bodily fluid leaks out of the access opening as a connection port, creating health risk to the operator and patient. Failure of the sealing member in returning to its closed position prevents the valve surface from being swabbable, causing an IV therapy to be open to bacterial growth.

[0008] Summary

[0009] Primary object of the present application is to propose a needle-free connector assembly that overcomes shortcomings in the prior art. A further object of the present application is to propose a needle-free connector assembly that provides a facilitated use, without compromising the sealing in a closed state thereof. These objects are achieved by the set of features that constitute the appended claim 1.

[0010] Brief Description of the Drawings

[0011] Fig. la is side view of an exemplary assembly according to the present disclosure.

[0012] Fig. lb is H-H section of the assembly based on Fig. la.

[0013] Fig.lc is a close-up view based on detail K from Fig. lb.

[0014] Fig.2a is perspective view of an exemplary sealing member embodiment for an assembly according to the present disclosure.

[0015] Fig.2b is another perspective view of the sealing member shown in Fig.2a.

[0016] Fig.3a is side view of an exemplary embodiment of the sealing member according to the present disclosure.

[0017] Fig.3b is J-J section view of the sealing member based on Fig.3a.

[0018] Fig.3c is plan view of the sealing member shown in Fig.3a. Fig.4a is side view of another exemplary embodiment of the sealing member according to the present disclosure.

[0019] Fig.4b is K-K section view of the sealing member based on Fig.4a.

[0020] Fig.4c is plan view of the sealing member shown in Fig.4a.

[0021] Fig.5a shows perspective view of another exemplary embodiment of the sealing member according to the present disclosure.

[0022] Fig.5b is plan view of the sealing member shown in Fig.5a.

[0023] Fig.5c is another perspective view of the sealing member shown in Fig.5a.

[0024] Fig.6a is exploded side view of an exemplary assembly according to the present disclosure.

[0025] Fig.6b is exploded section view of the assembly shown in Fig.6a.

[0026] Fig.7a is side view of the exemplary assembly shown in Fig.l, in engagement with a delivery device.

[0027] Fig.7b is side section view based on Fig.7a.

[0028] Fig.8a is perspective section view based on Fig.7b.

[0029] Fig.8b is close-up view of detail M from Fig.8a.

[0030] Detailed Description

[0031] With reference to the appended drawings, the present application proposes a connector assembly (100) for communication of a medical fluid. The medical fluid can be a bodily fluid such as blood, or any liquid that can be administered to a mammal; yet medically used gases, for example, air can also be considered as medical fluid within the context of the present application.

[0032] Fig. la is side view of an exemplary assembly according to the present disclosure. Fig. lb is

[0033] H-H section of the assembly based on Fig. la. Fig.lc is a close-up view based on detail K from Fig. lb. Referring to Fig. la to Fig.lc, the assembly (100) comprises an attachment part (1) for removably engaging a delivery device. The assembly (100) further comprises a connection part (2) for connecting to a container. Considering the terminology used in the related art, the attachment part (1) can be also named as a "cap" or "upper part of the valve", and the connection part (2) as a "lower part of the valve".

[0034] The assembly (100) further comprises a flexible sealing member (3) circumferentially enclosed between the attachment part (1) and connection part (2) around a main axis (A). Fig.2a is perspective view of an exemplary sealing member embodiment for an assembly according to the present disclosure. Fig.2b is another perspective view of the sealing member shown in Fig.2a. Fig.3a is side view of an exemplary embodiment of the sealing member according to the present disclosure. Fig.3b is J-J section view of the sealing member based on Fig.3a. Fig.3c is plan view of the sealing member shown in Fig.3a. Fig.4a is side view of another exemplary embodiment of the sealing member according to the present disclosure. Fig.4b is K-K section view of the sealing member based on Fig.4a. Fig.4c is plan view of the sealing member shown in Fig.4a. Fig.5a shows perspective view of another exemplary embodiment of the sealing member according to the present disclosure. Fig.5b is plan view of the sealing member shown in Fig.5a. Fig.5c is another perspective view of the sealing member shown in Fig.5a.

[0035] Referring to Fig.2a to Fig.5b; the sealing member (3) comprises a cylindrical body (30) extending along the axis (A). The sealing member (3) further comprises a sealing head (31) at an axially distal end of the sealing member (3) with regard to the body (30). The sealing head (31) can be considered arranged for being partially exposed through an access opening (11) of the attachment part (1). The sealing member (3) further comprises a cylindrical portion (32) between the body (30) and head (31).

[0036] Fig.6a is exploded side view of an exemplary assembly according to the present disclosure. Fig.6b is exploded section view of the assembly shown in Fig.6a. Referring to Fig.6a and Fig.6b, it can be considered that: the attachment part (1) has a hollow structure for axially receiving the sealing member (3) through an opening at a first side of the attachment part (1) that is arranged for engagement with the connection part (2), such that the head (31) is exposed through an access opening (11) that is distal to said first side; the sealing member (3) is axially held between the attachment part (1) and connection part (2) when the attachment part (1) and connection part (2) are attached to one another; when the attachment part (1) and connecting part (2) attached to one another, a foot portion (34) of the sealing member (3) distal to the head (31) rests with a lower side thereof on a seating surface (22) of the connection part (2); the attachment between the attachment part (1) and the connecting part (2) can be arranged by first introducing the sealing member (3) into the attachment part

[0037] (1) such that the head (31) opposes or partially enters into the access opening (11), then engaging the connecting part (2) to a distal end of the attachment part (1) with regard to the access opening (11); alternatively, said attachment can be performed by placing the foot portion (34) of the sealing member (3) onto the attachment part (1), for instance between one or more side walls (21) arranged for holding the foot portion (34) against radial movements with regard to the axis (A); then engaging the attachment part (1) onto the connecting part (2), such that the sealing member (3) is introduced into the connecting part (2) and the head (31) opposes and then at least partially enters into the access opening (11).

[0038] Accordingly, one or more of the following can be taken into consideration: the sealing member (3) can comprise a foot portion (34) at an axially distal end of the sealing member (3) with regard to the head (31); the foot portion (34) can be arranged for being in mechanical communication with the connection part (2). the connection part (2) can comprise a side wall (21) that is sized and shaped for supporting the foot portion (34) in radial directions towards the axis (A); thus, said mechanical communication between the foot portion (34) and the connection part

[0039] (2) is available at an enhanced extent in both of the first and second states.

[0040] The sealing member (3) is arranged to have a closed first state in which the head (31) is received into an access opening (11) of the attachment part. The sealing member (3) is further arranged to have an open second state in which the head (31) is retracted away from the access opening (11) (that is, towards the connection part 2) when compressed through the access opening (11) along the axis (A). For visualization of the open second state, Fig.7a gives a side view of the exemplary assembly shown in Fig.l, in engagement with a delivery device. Fig.7b is side section view based on Fig.7a. Fig.8a is perspective section view based on Fig.7b. Fig.8b is close-up view of detail M from Fig.8a.

[0041] Referring again to Fig.2a to Fig.5c, the sealing member (3) comprises one or more columns (33) on a side surface of the body (30). The columns (33) radially protrude away from the axis (A), and extend parallel to the axis (A) along the body (30).

[0042] The one or more columns (33) are sized and shaped for maintaining a positive value of distance to respective one or more axially opposing inner surfaces (12) of the attachment part (1), when in the first state. Therefore, the columns (33) do not contact to such axially opposing inner surfaces (12). So, when the sealing member (3) is axially compressed at the head (31) at taking the second state, radial widening of the body (30) is not obstructed by radially oriented friction forces between the columns (33) and respective axially opposing inner surfaces (12). This enables the transition from the closed first state to the open second state to take place with a decreased extent of effort by an operator that introduces a tip (80) of a delivery device. Thus, the above-mentioned positive value of distance provides ease of use to the assembly (100). On the other hand, the columns (33) provide an increased extent of resilience and potential energy accumulating capacity to the sealing member (3), in particular, to the body (30). This results in a facilitated recovery of the first state upon cessation of the axial compression onto the head (31). As a result, the transition from the closed first state to the open second state, as well as the transition to the closed first state from the open second state, are facilitated.

[0043] In a possible embodiment, the columns (33) can be sized and shaped for maintaining a positive value of distance to a radially opposing inner surface (13) of the attachment part (1), when in the normally closed first state. So, in such embodiment, the body (30) with columns (33) is arranged with radial play with respect to respective inner side surfaces (that is, radially opposing inner surfaces 13) of the attachment part (1). Thus, the sealing member (3) is easily deformed in radial directions with regard to the axis (A) when forced to the second state.

[0044] In a preferred embodiment, the sealing member (3) comprises three or more columns (33), which are preferably equally distributed around the axis (A). That is, in the case of three columns, radial angles in-between adjacent columns are 120 degrees each, on the basis of 360 degrees of full angle around the axis (A). Likewise, in the possible cases of four, six or eight columns, radial angles in-between adjacent columns are preferably 90, 60 or 45 degrees, respectively. This provides an enhanced extent of geometric uniformity to the sealing member (3) around the axis (A), at transition from the closed first state to the open second state. More preferably, the sealing member (3) comprises four or more columns (33), for example, six columns (33) that are equally distributed around the axis (A). As exemplary visualizations thereto, each of the sealing members (3) depicted in Fig.2a to Fig.3c and in Fig.5a to Fig.5c comprise four columns (33) that are equally distributed around respective axes (A) with 90 degrees of radial angles in-between columns that are adjacent to one another; whereas the sealing member (3) depicted in Fig.4a to Fig.4c comprise six columns (33) that are equally distributed around respective axes (A) with 60 degrees of radial angles in-between columns that are adjacent to one another, on the basis of 360 degrees full angle.

[0045] The sealing member (3) can comprise a slot opening (36) for receiving a tip (80) of a needle-free delivery device at being brought to the second state. Fig.2a, Fig.3c, Fig.4c and Fig.5b schematically show exemplary positioning and shape of a slot opening (36) formed on a head (31).

[0046] The foot portion (34) can axially extend from the body (30) away from the head (31). Referring to Fig.6b in conjunction with Fig. lb and Fig.7b, the foot portion (34) can be considered arranged to be in an annular contact with a respective seating surface (22) of the connection part (2) around the axis (A), thereby providing a sealing in radial directions with regard to the axis (A).

[0047] With reference to Fig.3b and Fig.4b, in radial directions with regard to the axis (A), the foot portion (34) can have a greater thickness (Tl) when compared to a thickness (T2) of the body (30). In this embodiment, the sealing member (3) inherently has an increased resilience at the foot portion (34) due to the increased material thickness at the same. As a result, the foot portion (34) substantially or fully retains its geometric shape even at transitions of the sealing member (3) between the open and closed states. Considering that the connection part (2) is inherently in contact with a corresponding surface of the foot portion (34) around the axis (A), and that the connection part (2) is inherently built of a rigid (that is, substantially less flexible) material when compared to the building material of the sealing means (3); this feature provides an enhanced extent of sealing between the foot portion (34) and connection part (2) in radial directions with regard to the axis (A). For instance, an inner diameter of the sealing member (3) at the body (30) and foot portion (34) can be substantially the same (e.g., with a difference within the range between 0 and 10 percent); and the foot portion (34) can have an outer diameter (DI) that is greater than an outer diameter (D2) of the body (30) (e.g., with a difference that is greater than 10 percent, more preferably, 20 percent or greater). In other words; preferably, a ratio of the thickness (Tl) at the foot portion (34) to the thickness (T2) at the body (30) is 1.1:1.0 or greater, and more preferably, 1.2:1.0 or greater.

[0048] Fig.2b, Fig.3c and Fig.4c schematically visualizes exemplary comparisons between the diameter (DI) of the foot portion (34) and diameter (D2) of respective body (30) in different exemplary embodiments of the sealing means (3). A similar comparison can be also made by observing the Fig.5b which shows plan view of another exemplary embodiment of sealing means (3) within the context of the present disclosure.

[0049] In a possible embodiment, the difference between a radius of the foot portion (34) and a radius of the body (30) is equal to a radial protrusion extent of the one or more columns

[0050] (33). In other words, a half of the difference between the diameter (DI) of the foot portion

[0051] (34) and the diameter (D2) of the body (30) is equal to a radial protrusion extent of the one or more columns (33). Thus, axial projections of the columns (33) towards the connection part (2) substantially or fully coincide with the foot portion (34). This measure reduces the geometric complexity and facilitates formation of the sealing member by molding. Fig. lb and Fig.2a to Fig.6b show various exemplary sealing members (3) in accordance with this measure. The sealing member (3) can be made from a silicon-based elastomeric material as commonly employed in the related art.

[0052] The side wall (21) can preferably be sized and shaped to circumferentially cover the foot portion (34) around the axis (A). So, when placed onto the connection part (2) at assembling, the sealing member (3) is held in place and easily introduced into the attachment part (1) at engaging the connection part (2) thereto. Furthermore, when in use, obstruction of medical fluid leakage between striking surfaces of the connection part

[0053] (2) and sealing member (3) is available not only in radial directions, but also in directions that are parallel to the axis (A). Examples of assemblies (100) according to this embodiment are particularly depicted in Fig. lb, Fig.6b, Fig.7b and Fig.8b.

[0054] In a possible embodiment, the sealing member (3) comprises a cylindrical portion (32) between the body (30) and head (31). Diameter of the cylindrical portion (32) can be smaller than the diameter (D2) of the body (30), and greater than that of the head (31). The sealing member (3) preferably comprises an intermediate portion (35) between the body (30) and head (31). It can be considered that the intermediate portion (35) is disposed between the cylindrical portion (32) and head (31). The intermediate portion (35) preferably has a frusto-conical geometry, diameter of which decreases from the cylindrical portion (32) towards the head (31). With reference to Fig. lb and Fig.lc, the intermediate portion (35) can be considered arranged for being in mechanical contact with a corresponding inner surface of the attachment part (1) when in the closed first state; such that the sealing member (3) is clamped in-between the attachment part (1) and connection part (2) at the intermediate portion (35) and foot portion (34), respectively. The intermediate portion (35) having a geometry of frustum of a cone minimizes friction force components parallel to the axis (A) between the sealing member

[0055] (3) and attachment part (1) at transitions between the closed first state and open second state. This fact further facilitates the transition from the closed first state to the open second state.

[0056] The attachment part (1) and / or connection part (2) can preferably include a Luer fitting such as Luer slip or Luer lock connector, more preferably, Luer lock connector for creating a threaded connection with the delivery device or container of further medium, respectively. The access opening (11) of the attachment part (1) is preferably formed on a female fitting, such as female Luer slip fitting or preferably, female Luer lock fitting. The connection part (2) preferably includes a male Luer fitting, such as a male Luer lock fitting that provides hydraulic communication to the sealing member-side of the head (34) through an inner cavity (38) of the sealing member (3). When the open second state takes place, a flow path is established between the access opening (11) and the fitting on the connection part (2). In the examples visualized in Fig. la, Fig. lb, Fig.6a and Fig.6b, respective access openings (11) of the exemplary attachment parts (1) are formed on female Luer lock fittings, and connection parts (2) include respective male Luer lock fittings.

[0057] The way of functioning of the assembly (100) according to the present disclosure can be also formulated as follows:

[0058] - The assembly (100) can be considered as a swabbable needle free valve having a collapsible sealing member (3), outer side walls of which is reinforced with the one or more columns (33). The sealing member (3) can be considered as an elastomeric valve stem. The attachment part (1) and connection part (2) constitute a valve body, or housing, when attached to one another.

[0059] - Connection part (2) of the assembly (100) as a swabbable needle-free valve can be connected to an intravenous (IV) line, a container, and the like. In the closed first state, the head (31) is pushed shut inside the access opening (11) to prevent fluid flow therethrough. When accessed by a tip (80) of a delivery device, such as a male Luer slip or Luer lock fitting tip on the end of a syringe or another IV component, the tip (80) forces the valve stem inwardly into the valve body upon which the tip (80) enters the slot opening (36) to open the valve stem and permit fluid flow to or from the delivery device, through its tip (80), and also through the now forced-open slot opening (36). Thus, the open second state takes place. Fig.7a to Fig.8b schematically visualize engagement with a tip (80) of a delivery device that result in transition from the closed first state to the open second state. Thanks to the geometric considerations of the one or more columns (33) and the elastomeric qualities of the sealing member (3), the sealing member (3) resiliently expands towards the access opening (11) to return to its normally-closed first state, once the tip (80) of the delivery device is removed from the assembly (100).

[0060] Once the tip (80) of the access device is removed from the assembly (100), columns (33) of the collapsible sealing member (3) assist the head (31) to enter into and be radially supported by the access opening (11). This easily results in closure of the slot opening (36) and thus, of the flow path. As a result, any leakage of medical fluid through the slot opening (36) or access opening (11) is prevented. With arrangement of size and shape of the attachment part (1) and sealing member (3) or head (31), a proper closure can be considered to correspond to an automatic axial level alignment between a top exposed surface (37) of the head (31) and an upper surface of the attachment part (1). Preferably, the exposed surface (37) of the head (31) is flat, that is, planar. This facilitates wetting of the head (31), in other words, spreadability of a disinfecting solution of a cleaning cap for an effective swabbing.

[0061] Reference si

[0062] 1 attachment part

[0063] 11 access opening

[0064] 12 axially opposing inner surface (of the attachment part)

[0065] 13 radially opposing inner surface (of the attachment part)

[0066] 2 connection part

[0067] 21 side wall (of the attachment part)

[0068] 22 seating surface

[0069] 3 sealing member

[0070] 30 body

[0071] 31 head

[0072] 32 cylindrical portion

[0073] 33 column

[0074] 34 foot portion

[0075] 35 intermediate portion

[0076] 36 slot opening

[0077] 37 exposed surface

[0078] 38 inner cavity (of the sealing member)

[0079] 80 tip

[0080] 100 assembly

[0081] A axis

[0082] DI diameter of the foot portion

[0083] D2 diameter of the body

[0084] T1 thickness of the foot

[0085] T2 thickness of the body

Claims

Claims1. A connector assembly (100) for communication of medical liquids, comprising an attachment part (1) for removably engaging a delivery device, a connection part (2) for connecting a container, and a flexible sealing member (3) circumferentially enclosed between the attachment part (1) and connection part (2) around a main axis (A); the sealing member (3) comprises a cylindrical body (30) extending along the axis (A), a sealing head (31) at an axially distal end of the sealing member (3) with regard to the body (30), the sealing member (3) is arranged to have a closed first state in which the head (31) is received into an access opening (11) of the attachment part (1), and an open second state in which the head (31) is retracted away from the access opening (11) when compressed through the access opening (11) along the axis (A); the sealing member (3) further comprises one or more columns (33) on a side surface of the body (30); the columns (33) radially protruding away from the axis (A), and extending parallel to the axis (A) along the body (30); characterized in that the columns (33) are sized and shaped for, when in the first state, maintaining a positive value of distance to respective one or more axially opposing inner surfaces (12) of the attachment part (1).

2. Assembly according to claim 1, wherein the columns (33) are sized and shaped for, when in the first state, maintaining a positive value of distance to a radially opposing inner surface (13) of the attachment part (1).

3. Assembly according to any of claims 1 or 2, wherein the sealing member (3) comprises a foot portion (34) at an axially distal end of the sealing member (3) with regard to the head (31), arranged for being in mechanical communication with the connection part (2).

4. Assembly according to claim 3, wherein in radial directions with regard to the axis (A), the foot portion (34) has a greater thickness (Tl) when compared to a thickness (T2) of the body (30).

5. Assembly according to claim 4, wherein an inner diameter of the sealing member (3) at the body (30) and foot portion (34) has an identical value or has a difference of up to 10 percent; and the foot portion (34) has an outer diameter (DI) that is greater than an outer diameter (D2) of the body (30) at a ratio that is greater than 10 percent.

6. Assembly according to claim 5, wherein the outer diameter (DI) of the foot portion (34) is greater than an outer diameter (D2) of the body (30) at a ratio that is greater than 20 percent.

7. Assembly according to any of claims 3 to 6, wherein the foot portion (34) axially extends from the body (30) and has a diameter (DI) that is greater than a diameter (D2) of the body (30).

8. Assembly according to claim 7, wherein a half of the difference between the diameter (DI) of the foot portion (34) and the diameter (D2) of the body (30) is equal to a radial protrusion extent of the one or more columns (33).

9. Assembly according to any of claims 1 to 8, wherein the attachment part (1) comprises a side wall (21) that is sized and shaped for supporting the foot portion (34) in radial directions towards the axis (A).

10. Assembly according to claim 10, wherein the side wall (21) is sized and shaped to circumferentially cover the foot portion (34) around the axis (A).

11. Assembly according to any of claims 1 to 11, wherein the sealing member (3) comprises a cylindrical portion (32) between the body (30) and head (31).

12. Assembly according to any of claims 1 to 12, wherein the sealing member (3) comprises an intermediate portion (35) between the body (30) and head (31), the intermediate portion (35) having a frusto-conical geometry, diameter of which decreases towards the head (31).

13. Assembly according to claim 13, wherein the sealing member (3) comprises a cylindrical portion (32) between the body (30) and head (31), and the intermediate portion (35) is disposed between the cylindrical portion (32) and head (31).

14. Assembly according to any of claims 1 to 14, wherein the sealing member (3) comprises a slot opening (36) for receiving a tip (80) of a delivery device when in the second state.

15. Assembly according to any of claims 1 to 15, wherein the attachment part (1) comprises a female Luer lock fitting on which the access opening (11) is formed, andthe connection part (2) includes a male Luer lock fitting in hydraulic communication with an inner cavity (38) of the sealing member (3).

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