CONNECTOR FOR A MEDICAL CONTAINER

Abstract

A connector for a medical container is described. The connector includes a connector element defining an inner lumen extending axially from a first end of the connector element to a second end of the connector element that is opposite the first end. The connector element includes a fastening section at the first end of the connector element that is secured to the medical container, a pinch-off section extending from the fastening section towards the second end of the connector element, a head section extending from the pinch-off section towards the second end of the connector element, and a deflection element extending from the head section towards the first end of the connector element.

Claims

1. A connector for a medical container, the connector comprising: a connector element defining an inner lumen extending axially from a first end of the connector element to a second end of the connector element that is opposite the first end, the connector element comprising: a fastening section at the first end of the connector element, the fastening section configured to be secured to the medical container; a pinch-off section extending from the fastening section towards the second end of the connector element; a head section extending from the pinch-off section towards the second end of the connector element; and a deflection element extending from the head section towards the first end of the connector element, wherein the deflection element terminates at an end that extends far enough into a portion of the inner lumen defined by the pinch-off section to protect the pinch-off section without hindering reliable pinching of the pinch-off section.

2. The connector of claim 1, wherein the deflection element does not axially overlap with the head section.

3. The connector of claim 1, wherein an axial length of the deflection element is less than an axial length of the pinch-off section.

4. The connector of claim 1, wherein the deflection element protects the pinch-off section from a needle inserted into the inner lumen.

5. The connector of claim 1, further comprising: a closure element configured to attach to the head section of the connector element; and a membrane element between the connector element and the closure element, the membrane element configured to seal the inner lumen at the second end of the connector element.

6. The connector of claim 5, wherein the deflection element does not axially overlap with the closure element.

7. The connector of claim 5, wherein the head section comprises a locking rim that extends radially beyond the deflection element, the locking rim configured to engage the closure element.

8. The connector of claim 7, wherein the head section comprises another rim that extends radially beyond the deflection element, the another rim configured to receive an end of the closure element.

9. The connector of claim 8, wherein the other rim extends radially beyond the locking rim.

10. The connector of claim 8, wherein the deflection element extends from the other rim towards the first end of the connector element.

11. The connector of claim 5, further comprising a break-off part extending from the closure element.

12. The connector of claim 5, wherein the membrane element is a self-sealing membrane.

13. The connector of claim 1, wherein a diameter of the portion of the inner lumen defined by the pinch-off section is greater than a diameter of the deflection element.

14. The connector of claim 1, wherein the deflection element is radially spaced from the pinch-off section.

15. The connector of claim 1, wherein the deflection element is cylindrically-shaped.

16. The connector of claim 1, wherein the pinch-off section is flexibly deformable for pinching off the inner lumen.

17. The connector of claim 1, wherein a lumen defined by the deflection element is aligned with a portion of the inner lumen defined by the head section.

18. The connector of claim 1, wherein the connector element is integrally formed as one piece.

19. The connector of claim 1, wherein the fastening section is configured to be welded between two layers of the medical container to be secured to the medical container.

20. The connector of claim 1, wherein the medical container is filled with a medical fluid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The idea underlying the invention shall subsequently be described in more detail with reference to the embodiments shown in the figures. Herein,

[0020] FIG. 1 shows a schematic view of a medical container in the shape of a three-chamber flexible bag comprising three connectors;

[0021] FIG. 2A shows a front view of a connector element of a connector;

[0022] FIG. 2B shows a side view of the connector element;

[0023] FIG. 2C shows a top view of the connector element;

[0024] FIG. 3A shows a sectional view along line A-A according to FIG. 2A;

[0025] FIG. 3B shows a sectional view along line B-B according to FIG. 2B;

[0026] FIG. 4A shows a sectional view of the connector element with a closure element attached to a head section of the connector element; and

[0027] FIG. 4B shows the view of FIG. 4A, with a break-off part broken off the closure element and with a needle of a delivery device inserted into the connector element.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0028] FIG. 1 shows in a schematic view a medical container 1 in the shape of a flexible bag made of thin, flexible foils welded to each other. The medical container 1, in the shown embodiment, comprises three chambers 10-12 for receiving medical fluids, for example for the parenteral feeding of a patient. The chambers 10-12 herein may contain different medical fluids, for example a glucose solution, a fat solution and an amino acid solution, wherein the chambers 10-12 may be connected via tearable seams which may be torn open to bring the chambers 10-12 in fluid connection with each other for mixing the different solutions with each other prior to delivering them to a patient.

[0029] Each chamber 10-12 is associated with a connector 2, as shown in FIG. 1. The chambers 10-12 herein are filled via their respective connectors 2, for example by a medical supplier or within a hospital pharmacy or the like. After the chambers 10-12 have been filled, the connectors 2 are closed such that the chambers 10-12 are sealed towards the outside and the medical container can be stored or delivered for use on a patient. The mixing of the different solutions contained in the chambers 10-12 then takes place immediately prior to injecting the medical fluid of the medical container 1 to a patient in that a user, for example a nurse, tears open the tearable seams in-between the chambers 10-12 such that the solutions contained in the chambers 10-12 can mix within the medical container 1.

[0030] As shown in FIGS. 4A and 4B, each connector 2 comprises a connector element 20, a closure element 21 and a membrane element 22 placed in-between the closure element 21 and the connector element 20.

[0031] Detailed views of the connector element 20 are provided in FIGS. 2A to 2C and 3A and 3B. The connector element 20 comprises a fastening section 200 which can be inserted in-between foils of the medical container 1 for welding the connector element 20 to the medical container 1. The fastening section 200 is adjoined by a pinch-off section 201, which terminates in a head section 202. To the head section 202 the closure element 21 is attached via an attachment section 210 in a form locking manner by engaging with a locking rim 203 of the head section 202.

[0032] The closure element 21, when it is attached to the head section 202 of the connector element 20, closes off an opening 204 in the head section 202. The closure element 21 comprises a head section 211 adjoining the attachment section 210 and being connected, in the state of FIG. 4A, to a break-off part 214 along a circumferential break line 213.

[0033] For manufacturing the medical container 1, the connector elements 20 of the connectors 2 are placed in-between the foils of the medical container 1 and are welded to the foils when forming the chambers 10-12 of the medical container 1. After completion of the manufacturing, the chambers 10-12 of the medical container 1 are filled for example by a medical supplier or in a pharmacy of a hospital by inserting a filling spike into the respective connector elements 20 and by filling the chambers 10-12 with medical solutions as desired.

[0034] Once a chamber 10-12 has been filled, the respective connector element 20 is pinched-off at its pinch-off section 201 by applying a suitable clamping device. For this, the connector element 20 is flexibly deformable at its pinch-off section 201, which comprises a reduced wall thickness W1 in comparison to other sections of the connector element 20, for example in comparison to a wall thickness W2 of the walls 208 of the fastening section 201, as depicted in FIG. 3A.

[0035] By pinching off the connector element 20 at its pinch-off sections 201, a fluid path through the connector element 20 is blocked in that an inner lumen L enclosed by the pinch-off section 201 is pinched-off. Subsequently, the closure element 21 can be attached to the head section 202 of the connector element 20 for closing the connector element 20, and the pinching of the pinch-off section 201 can be released.

[0036] After all chambers 10-12 have been filled and respective closure elements 21 have been attached to the connector elements 20 of the connectors 2, the medical container 1 can be stored or can be delivered to a place of usage, for example to a hospital.

[0037] Once the medical solution contained in the medical container 1 shall be administered to a patient, a user may break off one or multiple of the break-off parts 214 of the closure elements 21 of the connectors 2 and may insert a needle 30 of a suitable delivery device 3, for example a syringe, into an opening 212 within the head section 211 of the closure element 21 and may pierce the membrane element 22 held in-between the closure element 21 and the connector element 20. By piercing the membrane element 22 by means of the needle 30 and by inserting the needle 30 in an insertion direction I into the connector element 20 through the opening 204 of the head section 202 of the connector element 20, a medical fluid may be added to the medical container 1 or a medical fluid may be extracted from the medical container 1. For example, if the medical container 1 comprises different solutions for the parenteral feeding of a patient, further components such as vitamins or the like may be added via one of the connectors 2 prior to administering the (mixed) solutions to a patient.

[0038] The membrane element 22 is constituted as a self-sealing membrane which, after removing the needle 30 of the delivery device 3, seals itself such that the connector element 20 is closed in a fluid-tight manner towards the outside.

[0039] When inserting the needle 30 of the delivery device 3 through the head section 202 of the connector element 20 towards the inner lumen L enclosed by the pinch-off section 201, it shall be avoided that the needle 30 pierces the walls 207 of the pinch-off section 201 (having a reduced wall thickness W1 as shown in FIG. 3A). For this, a deflection element 205 having the shape of a cylindrical pipe is provided which extends from the head section 202 towards the inner lumen L of the pinch-off section 201, as shown in the sectional views of FIGS. 3A and 3B. The deflection element 205 comprises a longitudinal guide opening 206 which is aligned along the insertion direction I with the opening 204 of the head section 202 such that the needle 30 of a delivery device 3 is guided via the deflection element 205 towards the inner lumen L of the pinch-off section 201, as shown in FIG. 4B.

[0040] The deflection element 205 in the shape of a cylindrical pipe is formed in one piece with the connector element 20 and has a rigid shape such that a needle 30 pinching onto the inner circumferential face of the guide opening 206 is deflected and guided in the insertion direction I or is stopped such that it cannot come into contact with the outer walls 207 of the pinch-off section 201. Hence, the risk that the walls 207 of the pinch-off section may be damaged by the needle 30 is reduced.

[0041] The deflection element 205 extends from the head section 202 in the insertion direction I and reaches into the inner lumen L of the pinch-off section 201. It herein is placed inside the pinch-off section at a radial distance to the walls 207.

[0042] Although the deflection element 205 reaches into the inner lumen L of the pinch-off section 201, it does not extend through the pinch-off section 201 and in particular reaches into the inner lumen L only that far that a reliable pinching of the pinch-off section 201 is not hindered.

[0043] The connector element 20, as visible from the top view of FIG. 2C, has the general shape of a ship, with the fastening section 200 reducing in width towards both sides along a horizontal direction H such that the fastening section 200 may be reliably welded to the foils of the medical container 1 for providing a fluid-tight transition. The pinch-off section 201 likewise does not have a circular cross-section, but is formed such that it may be reliably pinched-off in a pinch-off direction P (see FIG. 3A) for closing off the fluid path through the connector element 20, as it is described for example in WO 2004/084793 A1.

[0044] The invention is not limited to the embodiments described above, but may be implemented in an entirely different fashion.

[0045] In particular, the invention is not limited to three-chamber medical bags, but may be applied to any sort of medical containers, having one, two or more chambers.

[0046] The medical container not necessarily is flexible, but may also have a rigid shape, such as the shape of a bottle or the like.

[0047] Each chamber of the medical container may be provided with one, two or more connector(s) according to the present invention. It is also understood that the medical container may provided with a mixture of both, inventive connector(s) and connector(s)/port(s) of the prior art, depending on the needs for the use of said container.

LIST OF REFERENCE NUMERALS

[0048] 1 Medical container (bag) [0049] 10-12 Chamber [0050] 2 Connector [0051] 20 Connector element [0052] 200 Fastening section [0053] 201 Pinch-off section [0054] 202 Head [0055] 203 Locking rim [0056] 204 Opening [0057] 205 Deflection element [0058] 206 Guide opening [0059] 207, 208 Walls [0060] 21 Closure element [0061] 210 Attachment section [0062] 211 Head section [0063] 212 Opening [0064] 213 Break line [0065] 214 Break-off part [0066] 22 Membrane [0067] 3 Delivery device [0068] Needle [0069] H Horizontal direction [0070] I Insertion direction [0071] L Inner lumen [0072] P Pinch-off direction [0073] W1, W2 Wall thickness