Connection assembly for directing a medical liquid

Abstract

A connection assembly configured to deliver a medical liquid to a container is described. The connection assembly includes a connecting member connected to the container, an attachment member, and a sealing element. The attachment member defines a lumen, a first end to be connected to a delivery device, and a second end connected to the connecting member. The sealing element is disposed in the lumen of the attachment member and includes a sealing head, a flange, and a foot portion. The sealing head seals the lumen of the attachment member, and the flange and the foot portion engage the connecting member.

Claims

1. A connection assembly configured to deliver liquid to a container, the connection assembly comprising: a connecting member configured to be connected to the container, the connecting member defining a contact surface and a recess extending axially in a first direction into the contact surface; an attachment member defining a lumen, a first end configured to be connected to a delivery device, and a second end connected to the connecting member; and a sealing element disposed between the connecting member and the attachment member, the sealing element comprising: a sealing head, a shoulder portion configured to engage the attachment member, a flange defining an outer perimeter that directly rests on the contact surface, a cylindrical body between the shoulder portion and the flange, wherein a largest outer diameter of the cylindrical section is smaller than a smallest outer diameter of the shoulder portion, and a foot portion extending axially in the first direction from the flange, the foot portion being received within the recess of the connecting member, wherein the sealing head is configured to seal the lumen of the attachment member.

2. The connection assembly of claim 1 wherein the sealing element further comprises a cylindrical section between the sealing head and the shoulder portion.

3. The connection assembly of claim 1, wherein the sealing element is spaced radially from the attachment member to allow radial deformation of the sealing element.

4. The connection assembly of claim 1, wherein the sealing head is disposed in an opening of the attachment member.

5. The connection assembly of claim 1, wherein the sealing head comprises a slot configured to be opened with engagement of the delivery device, such that the liquid can be delivered into the container.

6. The connection assembly of claim 1, wherein the sealing element extends axially from a bottom end to a top end opposite the bottom end, the sealing head is at the top end of the sealing element, and the foot portion is at the bottom end of the sealing element.

7. The connection assembly of claim 1, wherein the flange extends radially outward from the foot portion such that an outer diameter of the flange is larger than an outer diameter of the foot portion.

8. The connection assembly of claim 2, wherein the shoulder portion extends radially outward from the cylindrical section such that an outer diameter of the shoulder portion is larger than an outer diameter of the cylindrical section.

9. The connection assembly of claim 1, wherein the cylindrical body is configured to deform to create a flow path through the sealing element.

10. The connection assembly of claim 1, wherein the cylindrical body has a recess on its outer side.

11. The connection assembly of claim 1, wherein the sealing element is formed as a single piece.

12. The connection assembly of claim 1, wherein the sealing element is disposed entirely within the lumen of the attachment member.

13. The connection assembly of claim 1, wherein the sealing head has an outer surface that is substantially flat or convex.

14. The connection assembly of claim 1, wherein the connecting member comprises a first end configured to be connected to the attachment member and a second end configured to be connected to the container, the contact surface and the recess being defined at the first end.

15. The connection assembly of claim 1, wherein the contact surface is flat.

16. The connection assembly of claim 15, wherein the connection assembly defines a central axis extending from the connecting member to the attachment member, and wherein the contact surface is perpendicular to the central axis.

17. The connection assembly of claim 1, wherein the contact surface faces a second direction opposite the first direction.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The idea underlying the invention is clarified below on the basis of the exemplary embodiment described in the figures. Shown are:

(2) FIG. 1 a view of a container in the form of a bag with connectors arranged on it, to which attachment parts are attached;

(3) FIG. 2 an exploded view of the connector and the attachment part with sealing elements arranged between them;

(4) FIG. 3 a separate view of a connector with an attachment part attached;

(5) FIG. 4 a front view of an arrangement according to FIG. 3;

(6) FIG. 5 a sectional view on a cross-sectional plane corresponding to the drawing plane according to FIG. 4;

(7) FIG. 6 a separate view of an attachment part;

(8) FIG. 7 a separate view of a sealing element;

(9) FIG. 8A a front view of the connector;

(10) FIG. 8B a side view of the connector;

(11) FIG. 9 a view of an attachment part on the connector with the detachable part broken off;

(12) FIG. 10 an enlarged view of the attachment part with the detachable part broken off;

(13) FIG. 11 the sectional view according to FIG. 5 with the detachable part broken off;

(14) FIG. 12A a schematic view of a delivery device in the form of a syringe on the connector;

(15) FIG. 12B a cross-sectional view of a delivery device (here in the form of a syringe) connected to the connector;

(16) FIG. 13 a view of a connection assembly in the form of a y-connector; and

(17) FIG. 14 an exploded view of the arrangement according to FIG. 13.

DETAILED DESCRIPTION

(18) FIG. 1 shows container 1 in the form of a flexible bag, which has a bag body 10 for receiving a medical liquid, for example a medicine, a saline solution or a nutrient solution or the like. A medical liquid can be stored in container 1, wherein liquid can be filled into container 1 or removed from container 1 via connectors 11, 12.

(19) Connectors 11, 12 create access to container 1. In the illustrated exemplary embodiment, there is a first connector 11, here designed to allow, together with attachment part 2, connection of delivery device 5 in the form of a syringe (see FIGS. 12A and 12B), so that a liquid component can be delivered into container 1 via connector 11. The second connector 12, however, together with attachment part 3, provides an access by which an infusion set, for example, can be connected to container 1 in order to supply a liquid from container 1 to a patient.

(20) FIG. 2 shows in an exploded view the connection assemblies which are formed by connectors 11, 12, attachment parts 2, 3 and associated sealing elements 4, 6 between connectors 11, 12 and attachment parts 2, 3. Connectors 11, 12 are to be placed between sheets to create container 1 and are welded to the sheets so that connectors 11, 12 are integrally bonded to the sheets. Attachment parts 2, 3 are to be attached to connectors 11, 12 to complete container 1, so that sealing elements 4, 6 are located between attachment parts 2, 3 and connectors 11, 12 and in this manner a transition between attachment parts 2, 3 and connectors 11, 12 is sealed liquid-tight.

(21) Each attachment part 2, 3 has a detachable part 20, 30 which can be broken off to create an access to container 1. Detachable part 20 can be broken off from attachment part 2 to attach delivery device 5 in the form of a syringe to attachment part 2 and, through it, to provide liquid into container 1. Detachable part 30 can be broken off of attachment part 3 in order, for example, to stick an infusion set with a spike through sealing element 6 and take liquid through it from container 1 to supply the liquid to a patient, for example.

(22) Each attachment part 2, 3 also has a connection section 21, 31, which can be brought into engagement with associated connectors 11, 12, so as to create a positive lock connection between respective attachment pieces 2, 3 and associated connectors 2, 3.

(23) The connector provided by first connector 11 and attachment part 2 attached thereto is explained below.

(24) FIGS. 3 to 11 show an exemplary embodiment of a connector including connector 11 and attachment part 2. Connector 11 is here, as previously described, bonded to sheets of container 1 and is thus incorporated in an integral manner between the sheets. Attachment part 2 can be attached to connector 11 so that, in its attached position, attachment part 2 is held in a positive-lock manner on connector 11.

(25) The attachment part 2 has a first section comprising connection section 21 and threaded portion 22, which connects to it, and detachable part 20. Attachment part 2 is formed in one piece as a plastic molded part and associated in its initial state with detachable part 20 attached to threaded portion 22.

(26) Connector 11 has flow opening 111, which is closed to the outside by attachment part 2 when attachment part 2 is attached to connector 11, so that no liquid can get out of container 1 or into container 1. As is visible from the sectional view according to FIG. 5, when attachment part 2 is attached, connector 11 then engages with head 110 into opening 210 of connection section 21 and, axially via a circumferential positive-lock element in the form of annular projection 115, and via positive-lock elements 116, 117 in the form of axially extending webs and grooves is connected in a rotationally stable manner to attachment part 2. Within opening 210 of connection section 21 of attachment part 2, complementary positive-lock elements in the form of, for example, annular recesses are thus formed to engage with circumferential positive-lock element 115 and in the form of axially extending webs and/or grooves to engage with webs 116 and grooves 117.

(27) When attachment part 2 is attached to connector 11, sealing element 4 is between attachment part 2 and connector 11 and is held in a clamping manner between attachment part 2 and connector 11. Sealing element 4 can be inserted in insertion direction E into opening 210 inside attachment part 2 (see FIG. 6). Sealing element 4, as shown in FIG. 7, is formed as a rotationally symmetrical body and has a sealing head 40, which is in engagement opening 221 of threaded portion 22 and protrudes with convexly curved or flat side 400 out past threaded portion 22 in the direction of detachable part 20. Side 400 can also, however, be flush with the upper side of threaded portion 22.

(28) Cylindrical section 41, which merges into shoulder 410, connects to sealing head 40, which rests on circumferential conical support surface 212 in the inner transition between connection section 21 and threaded portion 22 of attachment part 2 when sealing element 4 is set into opening 210. Cylindrical section 41 here has a larger diameter than sealing head 40.

(29) A cylindrical body 42, which is inserted with a clearance in opening 210 of connection section 21, is connected to shoulder 410, which projects radially outward past section 41 and surrounds sealing element 4. Cylindrical body 42 here has a smaller diameter than shoulder 410. Since body 42 is inserted in opening 210 with a radial distance from the circumferential wall of connection section 21, sealing element 4 can be deformed in an advantageous manner by the attachment of delivery device 5 to create a flow through sealing element 4 between delivery device 5 and container 1.

(30) Body 42 carries a circumferential flange 420 on an end facing away from sealing head 40. Flange 420 rests with its lower side 422 on support surface 114 of connector 11. Its upper side 421 can be completely exposed. Upper side 421 is, in this case, not covered. It is not in contact or engagement with a corresponding component. For example, upper side 421 is not covered with a clamping surface of connector 2. Upper side 421 of flange 420 can also be only partially exposed. In this embodiment, flange 420 can be between annular projection 211 of connection section 21 and contact surface 114 on head 110 of connector 11 and thus be partially held in a clamping manner between annular projection 211 and contact surface 114 when attached part 2 is attached to connector 11. A radially outer section of flange 420 is held in a clamping manner.

(31) Above flange 420 or on a transition to flange 420, cylindrical body 42 has a recess 423 in is outer side. With this, the deformation of sealing element 4 can be supported when delivery device 5 is attached. Recess 423 is formed by a step in the outer side. In cross section, recess 423 has an essentially flat bottom. Recess 423, for example, has a box-like cross section. The base and the radial opening of recess 423 can have essentially the same dimensions (as viewed in insertion direction E).

(32) Foot section 43 connects to flange 420, which engages in recess 113 on head 110 of connector 11.

(33) In the attached position, attachment part 2 rests at the front on outer flange 112 of connector 11.

(34) Since sealing element 4 is supported on one side by shoulder 410 on attachment part 2 and on connector 11 by flange 420 and foot section 113 on the other, a defined, secured placement of sealing element 4 within opening 210 of attachment part 2 can be guaranteed. Through a cylindrical inner opening 44, which extends through body 42 and cylindrical section 41 of sealing element 4 starting from foot section 43 through to sealing head 40 and connects to tapered flow section 118 of connector 111, a higher flow between delivery device 5 and container 1 can be achieved when delivery device 5 is attached to attachment part 2. The inner opening 44 preferably has a diameter in a range of from 1 mm to 5 mm, preferably from 2 mm to 4 mm.

(35) In an initial state, represented in FIG. 5, attachment part 2 is attached together with sealing element 4 to connector 11, so that connector 11 is closed toward the outside. Sealing element 4 in this initial state is not accessible from the outside because upper side 400 of sealing head 40 in opening 221 of threaded portion 22 is covered towards the outside by detachable part 20.

(36) Detachable part 20 is connected via predetermined breaking point 200 in the form of a notch-like circumferential recess to threaded portion 22. In order to attach delivery device 5, in the form of a syringe for example, to attachment part 2 and in this manner create an access to container 1 for filling it with a liquid, a user can break detachable part 20 off of threaded portion 22 by gripping handle element 201 of detachable part 20 with his fingers and releasing detachable part 20 from threaded section 22, as is described in FIG. 9. When detachable part 20 is removed, attachment part 2 thus exists without detachable part 20, as is described in FIG. 10.

(37) After breaking off detachable part 20, sealing element 4 has its, for example, outward-facing side 400 on sealing head 40 exposed so that this outward-facing side 400 can be accessed from the outside. In one embodiment in which side 400 is formed convexly and projects over upper side 222 of threaded portion 22 in a curved manner, side 400 of sealing element 4 can be wiped or dabbed off in an efficient manner in order to clean and disinfect sealing element 4 in accordance with any legal requirements that may be present. Flat side 400 can also be appropriately wiped or dabbed off.

(38) Then delivery device 5 in the form of a syringe can, as shown in FIGS. 12A and 12B, be attached to threaded portion 22 by bringing connection element 50, in the form of a nut or union nut of delivery device 5, into contact with threads 220 via threads 500 on threaded portion 22 in a screw-like manner. Connecting piece 51 of delivery device 5 is inserted through this into engagement opening 221 on threaded portion 22, so that connecting piece 51 presses on sealing head 40 of sealing element 4, first presses this downward and then opens it at slot opening 45 (see FIG. 11). Connecting piece 51 thus penetrates sealing head 40 at slot opening 45 and enters into liquid communication with cylindrical opening 44 so that a flow is provided between delivery device 5 and flow opening 111 of connector 11.

(39) With the pressing of connecting piece 51 into engagement opening 221, sealing head 40 is also pressed into attachment part 2 and, together with the other sections 41, 42, forced aside into the available space radially outside section 42. When connecting piece 51 is fully inserted, connecting piece 51 creates a positive lock connection with engagement opening 221 and reaches through sealing head 40, which creates an efficient flow connection between connecting piece 51 and flow opening 118 on head 110 of connector 11, which is not affected, or only marginally so, by sealing element 4. Delivery device 5 extends itself at the latest when in a fully attached state, here fully tightened for example, with its connecting piece 51 through slot opening 45 of sealing element 4, so that a flow between delivery device 5 and container 1 can take place unhindered, or essentially unhindered, through sealing element 4. The whole cross section of the opening in delivery device 5, through which the liquid transport takes place is preferably exposed, as shown.

(40) Delivery device 5 has a syringe body 52 and a plunger 53, which can be pushed into syringe body 52 in order to convey in this manner a liquid from syringe body 52 into container 1.

(41) Because a, for example, cross-shaped or straight slot opening 45 is provided in sealing head 40 of sealing element 4, a needle-free access is created which can be accessed by using delivery device 5 without an injection needle. When delivery device 5 is attached, connecting piece 51 achieves engagement with slot opening 45 and in this manner opens sealing element 4 so that a flow between delivery device 5 and container 1 is created.

(42) After removing delivery device 5 from attachment part 2, sealing element 4 again closes automatically and seals itself, so that no liquid can escape from container 1.

(43) FIGS. 13 and 14 show a further exemplary embodiment in which a connection assembly comprising connector 11, attachment part 2 arranged on it and sealing element 4 is used.

(44) In this case, the connection assembly is a component of connector 7 in the form of a so-called y-connector. Connector 7 has two connection lines 70, 71 to each of which can be connected a medical line in the form of an infusion tube or the like. Line connections 70, 71 are in a flow connection with connector 11 at connection point 72 so that a medical liquid in a line system connected to line connection 70, 71 can be delivered or taken out of the line system via connector 11.

(45) Attachment part 2 is arranged on connector 11 in this exemplary embodiment. Sealing element 4 is clamped between attachment part 2 and connector 11. As in the exemplary embodiments according to FIGS. 1 to 12, threaded portion 22 of attachment part 2 is connected to detachable part 20, which can be broken off to connect a delivery device 5 (see FIG. 12) to threaded portion 22 and to further connect delivery device 5 to connector 11. Because sealing element 4 can protrude with its convex side 400 toward the outside over upper side 222 of threaded portion 22 and is thus easily accessed, side 400 of sealing element 4 can easily be wiped off before attaching delivery device 5 in order to disinfect outward-facing side 400 of sealing element 4. Flat side 400 can also be appropriately wiped or dabbed off.

(46) Connector 11 as well as attachment part 2 are identical in form and function to those previously described for the exemplary embodiment according to FIGS. 1 to 12B, so that the previous embodiments should be referenced.

(47) The idea underlying the invention is not confined to the previously described examples of the exemplary embodiment, but can also be accomplished in a completely different way.

(48) TABLE-US-00001 List of reference numbers  1 Bag  10 Bag body  11, 12 Connector 110, 120 Head 111 Flow opening 112 Flange 113 Recess 114 Bearing surface 115 Positive-lock element (annular projection) 116 Web 117 Notch 118 Flow opening  2 Attachment part  20 Detachable part 200 Predetermined breaking point 201 Handle element  21 Connection section 210 Opening 211 Annular projection 212 Contact surface  22 Threaded section 220 Threads 221 Engagement opening 222 Upper side  3 Attachment part  30 Detachable part  31 Connection section  4 Sealing element  40 Sealing head 400 Convex or flat side  41 Section 410 Shoulder  42 Body 420 Flange 421 Upper side of the flange 422 Bottom of the flange 423 Recess or step in the outside of the sealing element or of body 42  43 Foot section  44 Opening  45 Slot opening  5 Delivery device (syringe)  50 Connection element 500 Threads  51 Connecting pieces (syringe cone)  52 Syringe body  53 Plunger  6 Sealing element  7 Connector (70, 71) Line connection  72 Connection point E Insertion direction