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US-12623065-B2 - System comprising a cap for a medical fluid container and an attachment part, medical fluid container, and method for producing a fluid container

US12623065B2US 12623065 B2US12623065 B2US 12623065B2US-12623065-B2

Abstract

A system includes a cap for a medical fluid container and an attachment part. The cap includes at least one first port. The first port includes a septum and a connection structure. The attachment part includes a hollow spike and a joining structure in fluid communication with the hollow spike. The joining structure is configured for connecting the device for withdrawing fluid from the fluid container and/or for supplying fluid into the fluid container. The connection structure is configured to be connected to a complementary connection structure of the attachment part in a releasable or non-releasable manner such that the hollow spike of the attachment part pierces the septum.

Inventors

  • Juergen Fuchs
  • Juergen Hartung

Assignees

  • B. BRAUN MELSUNGEN AG

Dates

Publication Date
20260512
Application Date
20210628
Priority Date
20200630

Claims (19)

  1. 1 . A system comprising: a cap for a medical fluid container; and an attachment part, the cap comprising at least a first port for providing a fluid connection between the fluid container and a device, the device being configured for withdrawing fluid from the fluid container and/or for supplying fluid into the fluid container, the first port comprising a first septum and a connection structure, the attachment part comprising a hollow spike and a joining structure in fluid communication with the hollow spike, the joining structure being configured to connect the device to the fluid container, the connection structure configured to be connected to a complementary connection structure of the attachment part in a releasable or non-releasable manner such that the hollow spike pierces the first septum, wherein the connection structure comprises a valve.
  2. 2 . The system according to claim 1 , wherein the connection structure comprises a cone.
  3. 3 . The system according to claim 2 , wherein the connection structure comprises a threaded structure and/or an engagement structure configured to become engaged or to be engaged with a complementary threaded structure or a complementary engagement structure, respectively, of the attachment part in order to connect the connection structure to the attachment part.
  4. 4 . The system according to claim 3 , wherein the cap further comprises a second port, wherein the second port comprises a septum, and wherein the joining structure comprises a cone.
  5. 5 . The system according to claim 1 , wherein the cap further comprises a second port and the second port comprises a second septum.
  6. 6 . The system according to claim 1 , wherein a through fluid channel extends from a distal end of the hollow spike to the joining structure.
  7. 7 . The system according to claim 1 , wherein the joining structure comprises a cone.
  8. 8 . The system according to claim 1 , wherein the joining structure comprises a thread.
  9. 9 . The system according claim 1 , wherein the valve is configured as a slit valve.
  10. 10 . A medical fluid container comprising: the system according to claim 5 ; and a hollow body.
  11. 11 . The medical fluid container according to claim 10 , wherein: the hollow body is sealed in a fluid-tight manner, and/or the hollow body is collapsible.
  12. 12 . The medical fluid container according to claim 10 , wherein the hollow body is a hollow plastic body.
  13. 13 . The medical fluid container according to claim 12 , wherein at least a wall of the hollow body is formed of polyethylene.
  14. 14 . The medical fluid container according to claim 10 , wherein the cap is formed by injection molding onto a portion of the hollow body.
  15. 15 . The medical fluid container according to claim 14 , wherein at least one of the first septum and the second septum is formed by injection moulding onto the portion of the hollow body.
  16. 16 . The medical fluid container according to claim 15 , wherein the cap and at least one of the first septum and the second septum are formed by two-component injection molding.
  17. 17 . The medical fluid container according to claim 10 , wherein the cap is configured and arranged on the hollow body such that the hollow spike pierces the first septum and a portion of a wall of the hollow body when the attachment part is connected to the connection structure.
  18. 18 . The medical fluid container according to claim 17 , wherein at least one of the first port and the second port is sealed in a sterile manner.
  19. 19 . The medical fluid container according to claim 10 , wherein the hollow body is a hollow plastic body, wherein the hollow body is sealed in a fluid-tight manner, wherein the hollow body is collapsible, and wherein the cap is configured and arranged on the hollow body such that the hollow spike pierces the first septum of the first port and a portion of a wall of the hollow body when the attachment part is connected to the connection structure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the United States national stage entry of International Application No. PCT/EP2021/067723, filed Jun. 28, 2021, and claims priority to German Application No. 10 2020 208 146.8, filed Jun. 30, 2020. The contents of International Application No. PCT/EP2021/067723 and German Application No. 10 2020 208 146.8 are incorporated by reference herein in their entireties. BACKGROUND Infusions and transfusions are performed for therapeutic purposes in human and veterinary medicine. For example, infusions are used to administer liquids (e.g. active substance solutions or other liquid pharmaceuticals) into the bloodstream of a patient. For this purpose, the liquid to be administered is taken from a liquid container and flows through an infusion set (also called an “intravenous set” or “I. V. set”) to the patient access. The fluid enters the patient's bloodstream through the patient access. The patient access may be, for example, a venous cannula or a venous catheter. An infusion or transfusion set comprises a tube. Often, but not necessarily, the infusion or transfusion set has a drip chamber connected to the tube such that the fluid flows through the drip chamber into the tube. The infusion or transfusion set may optionally include other components, such as a flow regulator to control the rate of flow of the fluid, e.g. a roller clamp. If a drip chamber is provided, the drip chamber is connected to the container via a container connector such that fluid can pass from the container into the drip chamber. Otherwise, the tube is provided with such a container connector. The container connector may, for example, be a piercing device, such as a hollow mandrel which can be used to pierce a septum of the container and which has one or more fluid channels in its interior. Such a piercing device is commonly referred to as a “spike”. Other systems are also known for connecting the infusion or transfusion set to the container, for example coupling systems with plug-in connections. A “septum” is understood to be a container closure comprising a rubber membrane or a membrane made of another suitable elastic material. The membrane is pierced with a hollow piercing device to remove a fluid from the container or to introduce a fluid into the interior of the container. The piercing device may be the spike already described above, a cannula, a hypodermic needle, etc. The membrane is self-sealing, i.e. when the piercing device is withdrawn from the membrane again, the opening pierced by the piercing device closes at least partially, preferably completely. Accordingly, the membrane of a septum does not have a prefabricated opening in the form of a hole or slit into which the piercing device is inserted. A “fluid” is understood to mean a flowable material, in particular a liquid, a gas, a suspension or an aerosol. A container access is commonly referred to as a “port” in the case of medical fluid containers. Accordingly, the port is the area of the container to which an external device for fluid withdrawal or fluid addition is connected in order to establish fluid communication between the interior of the container and the external device. “Medical fluid containers” are understood to be containers that are intended to contain medical fluids and are made of a material suitable for this purpose. Medical fluids are, for example, liquid pharmaceuticals, liquid pharmaceutical components and blood for transfusion purposes. The liquid container from which the liquid to be administered is taken can be a bottle made of a rigid material such as glass. In addition, plastic bottles with a certain flexibility or plastic bags have become established on the market. Plastic not only has the advantage of having a lower specific weight and being less fragile than glass. If a sufficiently flexible plastic is used, another advantage is that the container collapses when liquid is removed from it. This means that the volume of the container interior continuously adapts to the decreasing volume of the liquid contained therein such that no additional provisions for pressure equalisation in the form of an air inflow channel or an air inflow opening are required, which not only simplifies the design but also avoids the risk of contamination of the container interior by inflowing air. Some of the containers for infusion fluids available on the market allow the addition of other medicines (so-called “pharmacy admixture”). Admixture is done, for example, by injection through another port on the container, which also has a septum. “Injecting” is understood to mean injecting by means of an injection syringe equipped with an injection needle, whereby the injection needle is pierced through the septum. Typically, this further port is located at a point on the container close to the position of the port via which the container connector of the infusion or transfusion set is connected to the container. By having mu