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EP-3240521-B1 - MOLDED FLUID TRANSFER ASSEMBLIES HAVING INCREASED WORKING PRESSURES AND BURST PRESSURES

EP3240521B1EP 3240521 B1EP3240521 B1EP 3240521B1EP-3240521-B1

Inventors

  • CASSIDAY, Bryan L.
  • SNYDER, Mitchell L.
  • DAMZYN, David
  • NIXON, THOMAS R.

Dates

Publication Date
20260506
Application Date
20151231

Claims (13)

  1. A fluid connection (10) comprising: a. a plurality of flexible polymeric tubes (40); b. an integral fluid connector (20) coupled to and in fluid communication with each of the plurality of tubes (40), wherein the fluid connector (20) is covalently bonded to the tubes (40), c. a shell (80) disposed over and encapsulating the fluid connector (20), wherein the inner cavity (28) of the fluid connector (20) has an essentially seamless transition with the tubes (40), and wherein the shell (80) is overmolded over the fluid connector (20) such that the fluid connector (20) is essentially encapsulated by the shell (80), wherein the shell (80) comprises a polypropylene.
  2. The fluid connection (10) of claim 1, wherein: - the plurality of tubes (40) are silicone reinforced tubes; - the integral fluid connecter (20) is an integral silicone fluid connecter coupled to the plurality of tubes (40) such that there is an essentially seamless transition between the inner cavity (42) of the plurality of tubes (40) and the fluid connector (20); and the shell (80) is a polypropylene shell, wherein the fluid connection is an autoclavable biopharmaceutical fluid connection.
  3. A method of forming a fluid connection (10), the method comprising: a. providing a plurality of tubes (40); b. integrally forming a fluid connector (20) about the plurality of tubes (40) wherein the fluid connector (20) is covalently bonded to the tubes (40), wherein the inner cavity (28) of the fluid connector (20) has an essentially seamless transition with the tubes (40); and c. forming a shell (80) over and encapsulating the fluid connector (20), wherein forming the shell (80) comprises overmolding the shell (80) over the fluid connector (20) such that the fluid connector (20) is essentially encapsulated by the shell (80), wherein the shell (80) comprises a polypropylene.
  4. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the fluid connection (10) has a working pressure of at least about 8.3 bar (120 psi).
  5. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the polymeric tubes (40) have an aseptic inner cavity (42), the fluid connector (20) has an aseptic inner cavity (28), the inner cavity (42) of the polymeric tubes (40) is in fluid communication with the inner cavity (28) of the fluid connector (20), and the shell (80) is composed of a material which is non-autoclavable.
  6. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein a coupling of the fluid connector (20) with the plurality of tubes (40) is the first point of failure in the working pressure of the fluid connection (10) before addition of the shell (80), and wherein after addition of the shell (80) disposed over and encapsulating the fluid connector (20), the coupling of the fluid connector (20) with the plurality of tubes (40) is not the first point of failure in the working pressure of the fluid connection (10).
  7. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein at least one of the tubes (40) comprises a thermoplastic elastomer.
  8. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the fluid connector (20) is bonded directly the tubes (40).
  9. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the fluid connector (20) has a shape of a tee, wye, elbow, cross joint, or straight connector.
  10. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the outer surface of fluid connector (20) comprises one or more surface features (24) comprising a protrusion, a depression, a groove, a channel, or combinations thereof.
  11. The fluid connection (10) or method of any one of claims 1, 2, and 3, wherein the shell (80) has a hardness greater than the hardness of the fluid connector (20) and the hardness of the tubing (40).
  12. The method of claim 3, wherein forming a fluid connector (20) comprises overmolding the fluid connector (20) about the tubes (40).
  13. A fluid transfer assembly comprising one or more of the fluid connections (10) of any one of claims 1 and 2.

Description

FIELD OF THE DISCLOSURE The present disclosure relates to fluid transfer assemblies, and more particularly to, fluid transfer assemblies including a fluid connector and flexible polymeric tubing for biopharmaceutical production. RELATED ART Fluid transfer assemblies are used in a variety of applications within fluid processing and management. Particularly, in the context of biopharmaceutical production, the transfer of sensitive fluid is paramount. Further, in particular fluid transfer systems, specialty tubing materials and connector materials must be used due to the sensitive nature of the fluid and the required. However, a common problem in the industry is the ability to adequately seal the connections between the tubing and connector while being able to sterilize the inner cavities of the tubing and connector. Currently, the working pressure is limited in such assemblies by the strength of the coupling between the tubing. US 2008/277926 A discloses a fluid connection with a plurality of flexible polymeric tubes coupled to and in fluid communication with an integral fluid connector, wherein a shell is overmolded over the fluid connector such that the fluid connector is encapsulated by the shell. However, the industry continues to demand higher and higher working pressures to improve the efficiency of production and enable more desirable fluid transfer characteristics. Accordingly, a need exists to develop better fluid connections methods between tubing. In this vein, the current inventors have been able to surprisingly and significantly increase the working pressure of such fluid connections to the point in some instances that the fluid connection is no longer the point of failure and the tubing itself or testing machine fail before the fluid connection. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments are illustrated by way of example and are not limited in the accompanying figures. FIG. 1 includes an illustration of a perspective partial cutaway view of a fluid connection in the form of a wye according to one embodiment.FIG. 2 includes an illustration of a perspective partial cutaway view of a fluid connection in the form of a tee according to one embodiment.FIG. 3 includes an illustration of a perspective partial cutaway view of a fluid connection in the form of a cross according to one embodiment.FIG. 4 includes an illustration of a perspective partial cutaway view of a fluid connection in the form of an elbow according to one embodiment.FIG. 5 includes and illustration of a perspective partial cutaway view of a fluid connection in the form of an reducing coupling according to one embodiment.FIG. 6 includes an illustration of a perspective partial cutaway view of a fluid connection with a fluid connector having a plurality of outer surface features according to one embodiment. Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the invention. DETAILED DESCRIPTION The following description in combination with the figures is provided to assist in understanding the teachings disclosed herein. The following discussion will focus on specific implementations and embodiments of the teachings. This focus is provided to assist in describing the teachings and should not be interpreted as a limitation on the scope or applicability of the teachings. However, other embodiments can be used based on the teachings as disclosed in this application. The terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a method, article, or apparatus that comprises a list of features is not necessarily limited only to those features but may include other features not expressly listed or inherent to such method, article, or apparatus. Further, unless expressly stated to the contrary, "or" refers to an inclusive-or and not to an exclusive-or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). Also, the use of "a" or "an" is employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one, at least one, or the singular as also including the plural, or vice versa, unless it is clear that it is meant otherwise. For example, when a single item is described herein, more than one item may be used in place of a single item. Similarly, where more than one item is described herein, a single item may be substituted for that more than one item. Unless otherwise defined, al