US-20260124113-A1 - CONNECTOR FOR A MEDICAL CONTAINER

US20260124113A1US 20260124113 A1US20260124113 A1US 20260124113A1US-20260124113-A1

Abstract

A connector is described for use with medical containers, such as flexible bags or rigid bottles, which significantly reduces the risk of damaging critical pinch-off sections during fluid access. The connector includes a connector element attachable to the medical container, featuring a head section and an adjoining pinch-off section that encloses an inner lumen. A closure element, which can include a pierceable membrane, is attachable to the head section to seal the fluid path. A deflection element extends from the head section towards the inner lumen of the pinch-off section. This deflection element guides a needle inserted through the membrane, ensuring it remains clear of the pinch-off section's walls, which may have reduced thickness for flexibility. As a result, the connector enables safe, cost-efficient filling, storage, and administration of medical fluids, supporting various container configurations and minimizing the risk of unintentional breach of sterility or functionality during use.

Inventors

Lars Karlsson
Torsten Brandenburger

Assignees

FRESENIUS KABI AB

Dates

Publication Date: 20260507
Application Date: 20250818

Claims (20)

1 . A pharmaceutical product comprising: a container comprising: a chamber containing a fluid; and a connector secured to the chamber, the connector comprising: a connector element extending between a first end and a second end, the connector element defining an inner lumen between the first end and the second 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 chamber; a pinch-off section extending from the fastening section towards the second end of the connector element; and a head section extending from the pinch-off section towards the second end of the connector element, wherein the head section comprises: a deflection element extending towards the first end of the connector element, wherein the deflection element terminates at an end that extends into a portion of the inner lumen defined by the pinch-off section to protect the pinch-off section without hindering pinching of the pinch-off section.
2 . The pharmaceutical product of claim 1 , wherein the head section comprises a locking rim.
3 . The pharmaceutical product of claim 2 , wherein the head section comprises another rim that extends radially beyond the locking rim, the another rim being closer to the first end of the connector element than the locking rim.
4 . The pharmaceutical product of claim 3 , wherein the deflection element is directly connected to and extends from the another rim.
5 . The pharmaceutical product of claim 3 , wherein the connector further comprises a closure element configured to lock to the locking rim of the head section and that axially terminates at the another rim of the head section when the closure element is locked to the connector element.
6 . The pharmaceutical product of claim 5 , wherein: the connector further comprises a membrane element between the connector element and the closure element, and the membrane element is configured to seal the inner lumen.
7 . The pharmaceutical product of claim 1 , wherein the deflection element is radially spaced from and within a wall of the pinch-off section.
8 . The pharmaceutical product of claim 1 , wherein the deflection element does not axially overlap with the head section.
9 . The pharmaceutical product of claim 1 , wherein: the chamber is formed from a plurality of flexible foils, and the fastening section is inserted in-between two of the plurality of flexible foils of the chamber.
10 . The pharmaceutical product of claim 1 , wherein the fastening section is welded to the chamber.
11 . The pharmaceutical product of claim 1 , wherein the fluid comprises a medical fluid for parenteral feeding of a patient.
12 . The pharmaceutical product of claim 11 , wherein the medical fluid for parenteral feeding of the patient comprises at least one of a glucose solution, a fat solution, or an amino acid solution.
13 . A pharmaceutical product comprising: a multi-chamber container wherein each chamber contains a fluid and wherein at least one chamber comprises: a connector secured to the chamber, the connector comprising: a connector element extending between a first end and a second end, the connector element defining an inner lumen between the first end and the second 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 chamber; a pinch-off section extending from the fastening section towards the second end of the connector element; and a head section extending from the pinch-off section towards the second end of the connector element, wherein the head section comprises a deflection element extending towards the first end of the connector element, wherein the deflection element terminates at an end that extends into a portion of the inner lumen defined by the pinch-off section to protect the pinch-off section without hindering pinching of the pinch-off section.
14 . The pharmaceutical product of claim 13 , wherein the head section comprises a locking rim and another rim that extends radially beyond the locking rim, wherein the another rim is closer to the first end of the connector element than the locking rim, and wherein the deflection element is directly connected to and extends from the another rim.
15 . The pharmaceutical product of claim 14 , wherein the connector further comprises a closure element configured to lock to the locking rim of the head section and that axially terminates at the another rim of the head section when the closure element is locked to the connector element, and wherein the connector further comprises a membrane element between the connector element and the closure element, the membrane element being configured to seal the inner lumen.
16 . The pharmaceutical product of claim 13 , wherein the deflection element is radially spaced from and within a wall of the pinch-off section and does not axially overlap with the head section.
17 . The pharmaceutical product of claim 13 , wherein the container comprises three chambers, and each chamber contains a different fluid.
18 . The pharmaceutical product of claim 17 , wherein the fluid comprises a glucose solution, a fat solution, or an amino acid solution.
19 . The pharmaceutical product of claim 17 , wherein the multiple chambers are connected via tearable seams configured to be torn open to bring the multiple chambers in fluid connection with each other for mixing of the different fluids with each other prior to delivery to a patient.
20 . A pharmaceutical product comprising: a three-chambered container, wherein each chamber of the three-chambered container comprises a different fluid and a connector secured to the chamber, each fluid comprising a glucose solution, a fat solution, or an amino acid solution, and wherein the connector of at least one chamber comprises: a connector element extending between a first end and a second end, the connector element defining an inner lumen between the first end and the second 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 chamber; a pinch-off section extending from the fastening section towards the second end of the connector element; and a head section extending from the pinch-off section towards the second end of the connector element, wherein the head section comprises a deflection element extending towards the first end of the connector element, wherein the deflection element terminates at an end that extends into a portion of the inner lumen defined by the pinch-off section to protect the pinch-off section without hindering pinching of the pinch-off section.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 19/043,551, filed Feb. 3, 2025, and issued as U.S. Pat. No. 12,390,398 on Aug. 19, 2025, which is a continuation of U.S. patent application Ser. No. 18/217,804, filed Jul. 3, 2023, and issued as U.S. Pat. No. 12,213,943 on Feb. 4, 2025, which is a continuation application of U.S. patent application Ser. No. 15/572,550, filed Nov. 8, 2017, now abandoned, which is a U.S. National Phase Application under 35 USC 371 of International Application No. PCT/EP 2016/059897, filed May 3, 2016, which claims the benefit of the priority date of European Patent Application No. 15166901.7, filed May 8, 2015, the contents of the aforementioned applications are incorporated herein in their entirety. BRIEF SUMMARY OF THE DISCLOSURE The invention relates to a connector for a medical container according to the preamble of claim 1. A connector of this kind comprises a connector element to be attached to the medical container for providing a port to the medical container. The connector element comprises a head section and a pinch-off section adjoining the head section, wherein the head section comprises an opening and the pinch-off section encloses an inner lumen being in fluid connection with the opening of the head section for providing a fluid path through the connector element. The opening of the head section can be closed by a closure element which is attachable to the head section of the connector element such that, when the closure element is attached to the head section, the fluid path through the connector element is blocked. A membrane element can be placed in-between the closure element and the head section of the connector element. The membrane element can be pierced by a needle of a delivery device, for example a syringe, for injecting a medical fluid into the medical container or for extracting a medical fluid from the medical container. The connector, when attached to a medical container, shall allow for filling the medical container with a medical fluid, for example a fluid for the parenteral feeding of a patient such as a glucose solution, a fat solution or an amino acid solution. The medical container herein may be filled for example by a medical supplier (which may be the container manufacturer) or in a pharmacy of a hospital and shall subsequently be prepared such that it can be stored and delivered for a later usage. For filling the container, as it is described in WO 2004/084793 A1, a filling spike of a filling station may be inserted into the connector element prior to attaching the closure element to the connector element. After the filling is completed, the connector element is pinched-off at its pinch-off section such that the fluid path through the connector element is closed and fluid cannot exit from the medical container through the connector element. By attaching the closure element to the head section of the connector element, then, the connector element is sealed towards the outside such that the pinching of the pinch-off section can be released, and the medical container can be stored or delivered to a hospital or the like. When using the medical container on a patient, the closure element may be opened, for example by breaking-off a break-off part. A user hence may access the connector element by piercing the membrane element placed in-between the head section of the connector element and the closure element using for example a needle of a syringe. In this way, fluid may be extracted from the medical container, or fluid may be added to the medical container in order to for example add further components such as vitamins or other nutritional components or the like to the fluid contained in the container. When piercing the membrane element using a needle, it shall be avoided that the needle comes into contact with the pinch-off section of the connector element, e.g., because the pinch-off section could have a reduced wall thickness in order for it to be deformable for pinching off the connector element. If the needle were to come into contact with the pinch-off section, there may be a risk of damaging the pinch-off section, possibly rendering the medical container unsterile and hence useless. It is clear that the invention relates to any kind of pinch-off section being in the danger to be damaged by the needle. Reasons therefore may the thickness of the wall, selection of material of the wall or other. The invention will be described by a connector with thinner walls at the pinch-off section in way of example only. It is an object of the invention to provide a connector for a medical container which in an easy and cost-efficient manner reduces the risk of damaging the pinch-off section of the connector element when piercing the membrane element by means of a needle. This object is achieved by means of a connector comprising the features of the independent claims. Accordingly, a deflection