Pipe Connector

Abstract

The disclosure herein relates to a flow path comprising a half clamp 1 having an inner surface surrounding the connection between a flexible tube 3 and a barb adapter 3, which can be placed within a clamshell to reduce or prevent deformation of the flexible tube when assembled.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The embodiments disclosed herein relate to connectors. More specifically, the embodiments described herein relate to a clamping system having two half clamps for connecting flexible tubing with a barb adapter, also referred to as a barb fitting. In one embodiment, the half clamps are held in place with at least one ear clamp and placed in a clamshell-style holder, referred to herein as a clamshell. [Background technology]

[0002] Single-use systems (SUS) have become an important asset in the development and scale-up of biotechnology processes. SUS currently used in the art provide increased manufacturing flexibility and reduced cleaning costs during development and changeover, but the flexible tubing and connections in these systems can struggle to withstand high pressure operation. SUS assemblies are most commonly made from polymeric materials. The pressure tolerance of plastic components such as SUS flexible tubing is generally lower than that of traditional stainless-steel piping systems.

[0003] Currently, cable ties, hose clamps, or barb clamps are commonly used in the art to provide secure connections to flexible tubing. These connection means have been observed to have insufficient pull-out strength in certain conditions, resulting in inherent leak paths. Safe, leak-free connections are particularly important in the medical and pharmaceutical fields, for example, in luer fittings, quick connects, and sanitary fittings such as those used in blood pumps, oxygen concentrators, sleep apnea machines, medical transport containers, and IV bags.

[0004] In flow paths made with low-hardness silicone tubing manifolds, the tubing has been observed to expand outward from the clamshell when subjected to pressures in excess of 2 bar, causing deformation of the tubing and potential leakage. For example, when subjected to 4 bar pressure, the silicone tubing has been observed to expand outward from the clamshell on all external interfaces. Expansion has also been observed on barb adapters that are at least partially inserted inside the tubing for external connections.

[0005] A system providing a unique single-use flow path housed within a hardware clamshell that allows the film or tube flow path to withstand high pressure applications up to or greater than 4 bar represents an inventive advancement in the art. Summary of the Invention [Problem to be solved by the invention]

[0006] The shortcomings of the prior art are overcome by the embodiments described herein, including several embodiments disclosed herein, which provide a flow path having a leak-resistant connection and a half clamp to reduce or prevent tube expansion and / or deformation. Further, in several embodiments, the flow paths described herein are adapted for high pressure applications that individually exceed the pressure ratings of each component of the flow path. [Means for solving the problem]

[0007] Certain embodiments described herein provide a flow path comprising at least one flexible tube, a barb adapter that is inserted into an interior cavity of the at least one flexible tube to form a connection between the at least one flexible tube and an inlet or outlet, two semicircular half clamps that surround the outside of the connection, a number of teeth on an inner surface of the half clamps, a locating groove on an inner surface of the half clamps, at least one ear clamp that secures the half clamps around the connection, and a sealing edge on the inside of the half clamps to radially compress the outer surface of the at least one flexible tube.

[0008] In some embodiments, the two half clamps of the flow channel are identical to one another. In some embodiments, the at least one ear clamp is in a recess on an outer surface of the half clamp. In some embodiments of the flow channel, the at least one ear clamp is made of a metal, such as stainless steel. In some embodiments, the flow channel further comprises a clam shell that mates with at least a portion of the outer surface of the half clamp. In some embodiments, the outer surface of the half clamp has a locating rib that can fit into a groove on the inner surface of the clam shell. In some embodiments, a protrusion on the ear clamp fits into a groove on the inner surface of the clam shell. In some embodiments, the inner surface of the clam shell comprises two or more grooves. In some embodiments, the at least one ear clamp is in two or more grooves. In some embodiments, at least one of the flexible tube, the barb adapter, and the half clamp is made of a polymeric material.

[0009] In some embodiments, the inlet and / or outlet are selected from flexible tubing or ports of the biocontainer. In some embodiments, the flexible tubing is low-duty silicone tubing. In some embodiments, two ear clamps secure the half clamp around the connection. In some embodiments, three, four, five, six, seven, eight, nine, or ten ear clamps secure the half clamp around the connection.

[0010] Several embodiments described herein provide a method for increasing the pressure resistance of a piping system, the method comprising the steps of inserting a barb adapter into a flexible tube, sliding at least one ear clamp over a surface of the flexible tube, positioning the half clamp over the barb adapter and the flexible tube by matching an inner positioning groove of the half clamp with a protrusion of the barb adapter to enclose the barb adapter and the flexible tube with the half clamp, compressing the tube with an inner sealing edge of the half clamp by tightening the ear clamp with a recess on an outer surface of the half clamp, and fixing the half clamp within the clam shell by inserting a positioning rib of the half clamp into a groove on an inner surface of the clam shell, thereby increasing the resistance of the piping system.

[0011] In some embodiments, the method increases the pressure resistance to more than 4 bar. In some embodiments of the method, the pressure resistance is increased by more than 2 bar. In some embodiments of the method, the pressure resistance is increased by less than 4 bar. In some embodiments of the method, the pressure resistance is increased to that of a stainless steel piping system. In some embodiments, the method further includes inserting at least one ear clamp into an additional groove on an inner surface of the clamshell. [Brief description of the drawings]

[0012] [Figure 1A] FIG. 2 is an exploded view of an embodiment of a half clamp. [Figure 1B] FIG. 1 illustrates an embodiment of an assembled set of half clamps. [Figure 2A] FIG. 2 is an exploded view of an embodiment of a half clamp. [Figure 2B] FIG. 1 illustrates an embodiment of an assembled set of half clamps. [Diagram 3] FIG. 2 is an exploded view of an embodiment of a flow path. [Figure 4] FIG. 2 illustrates an embodiment of a fully assembled flow path. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The accompanying drawings illustrate certain embodiments of the disclosure herein and should not therefore be considered limiting in scope, as the invention may admit of other equally effective embodiments. It should also be understood that elements and features of any embodiment may be found in other embodiments without further recitation, and where possible, the same reference numerals have been used to indicate equivalent elements common to the figures.

[0014] The disclosure herein describes certain embodiments of a flow path that includes a half clamp having an inner surface surrounding the connection of a flexible tube with a barb adapter. In some embodiments, the flexible tube is connected to a gas fluid source, a liquid fluid source, a fluid delivery location, or an additional flexible tube that allows gas or liquid fluid to flow through the flexible tube. Alternatively, in some embodiments, the flexible tube transports gas or liquid fluid into a biocontainer.

[0015] Turning now to the figures, Figs. 1A and 2A provide exploded views of an embodiment of half clamps 1a, 1b. Figs. 1B and 2B provide views of an embodiment of a set of assembled half clamps 1a, 1b. As shown in Figs. 1A, 1B, 2A, and 2B, in an embodiment, the flow path that minimizes tube expansion and / or deformation comprises two half clamps 1 (separately designated as 1a and 1b). In an embodiment, the two half clamps 1 are identical to each other. In an embodiment, the half clamps 1 are held together by an external force or device such as at least one ear clamp 4 (see Figs. 3 and 4). Alternatively, in an embodiment, one of the half clamps 1a comprises a male component and one of the half clamps 1b comprises a female component, which fits within the male component to secure the half clamps 1 together. In an embodiment, the male and female components interlock to couple the half clamps 1 to each other at a contact surface 10. Alternatively, in one embodiment, the two half clamps 1 are connected by a hinge (not shown).

[0016] In some embodiments, the half clamp 1 prevents deformation of the flexible tube 3 when it is subjected to high pressures of up to 4 bar by forming a clamping and supporting "shell" around the outer surface of the tube 3. In some embodiments, the half clamp 1 provides a complete radial seal around the outer surface of the flexible tube 3. In some embodiments, the complete radial seal is achieved by using sealing edges 5 on the inner surface of the half clamp 1 to compress the tube when the stainless steel ear clamps 4 are closed. In some embodiments, expansion of the tube 3 is prevented by locating ribs 6 on the outer surface of the half clamp 1, which are located in internal grooves 13 on the inner surface of the clamshell holder 12. In some embodiments, locating grooves 7 and friction ribs 8 on the inner surface of the half clamp 1 also help to reduce tube displacement. In some embodiments, the friction ribs 8 do not extend around the entire circumference of the inner surface of the half clamp 1. In some embodiments, locating grooves 7 and teeth 14 on the inner surface of the half clamp 1 also help to reduce tube displacement. In one embodiment, the outer surface of the half clamp 1 has dedicated recesses 9 for positioning the ear clamps 4 during assembly of the flow passage.

[0017] As shown in FIG. 3, in some embodiments, the barb adapter 2 includes at least one enlarged end 11. In some embodiments, the enlarged end 11 is a tri-clamp (TC) connection. In some embodiments, the TC connection is connected to another TC end. In some embodiments, the conical end of the barb adapter 2 is inserted into the opening of the flexible tube 3 and contacts the inner surface of the flexible tube 3. In some embodiments, at least a portion of the barb adapter 2 remains protruding from the flexible tube 3. In some embodiments, when the conical end of the barb adapter 2 contacts the inner surface of the flexible tube 3, it forces fluid through the opening of the barb adapter 2 and prevents fluid from flowing around the periphery of the barb adapter 2. For example, at least a portion of the barb adapter 2 may have an outer surface with a circumference that is the same as or greater than the circumference of the inner surface of the flexible tube 3 to facilitate contact, e.g., a snug connection, between the barb adapter 2 and the flexible tube 3. In some embodiments, the circumference of the barb adapter 2 is up to 10% greater than the circumference of the inner surface of the flexible tubing 3. In some embodiments, the contact between the barb adapter 2 and the inner surface of the flexible tubing 3 extends around the entire circumference of the inner surface of the flexible tubing 3. In some embodiments, the contact between the barb adapter 2 and the inner surface of the flexible tubing 3 extends around the entire circumference of the outer surface of the barb adapter 2.

[0018] In some embodiments, the barb adapter 2 comprises a metallic material. In some embodiments, the barb adapter 2 comprises a non-metallic material. In some embodiments, the non-metallic material is weldable. For example, the non-metallic material may be heat welded to a propylene or ethylene bag, such as a disposable biocontainer. In some embodiments, the non-metallic material is selected from U.S. Food and Drug Administration (FDA) approved polypropylene, silicone, thermoplastic elastomers (TPE), and thermoplastic rubbers (TPR). In some embodiments, the metallic material is a non-corrosive material, such as brass. In some embodiments, the non-metallic material is polyethylene. In some embodiments, the welding technique can be selected from the group consisting of plastic welding or heat sealing, such as ultrasonic welding, laser welding, welding with infrared radiation, or thermal welding.

[0019] In some embodiments, the half clamp 1 is held in place with at least one ear clamp 4. In some embodiments, the half clamp 1 is held in place with two ear clamps 4. In some embodiments, the half clamp 1 is held in place with three or more ear clamps 4. For example, an embodiment may include three, four, five, six, seven, eight, nine, or ten ear clamps 4. In some embodiments, the at least one ear clamp 4 is made of a material selected from stainless steel or plastic.

[0020] 4, in one embodiment, an assembly of half clamps 1 surrounding the outer surface of flexible tubing 3, for example, an outer surface of low hardness silicone with a hardness similar to that of DOW CORNING® Pharma-50 tubing, is assembled into a clamshell 12 to withstand a maximum pressure of 4 bar and prevent expansion of flexible tubing 3. In one embodiment, half clamps 1 surround the outer surface of flexible tubing 3 with barb adapter 2. In one embodiment, half clamps 1 contact each other to surround at least a portion of the outer surface of flexible tubing 3 with barb adapter 2 contacting the inner surface of flexible tubing 3.

[0021] Certain embodiments described herein allow the flow path to withstand pressure conditions that exceed the specified pressure rating of the flexible tubing 3 alone while preventing deformation of the tubing. In certain embodiments, the half clamp 1 reduces or prevents fluid leakage at the tubing connection. Safe, leak-proof connections of flexible tubing 3 are important in medical, pharmaceutical, automotive, industrial, and bioprocessing applications. In certain embodiments, liquids are not trapped within the connection, causing, for example, bacterial growth.

[0022] I. Assembly In some embodiments, the flow passage is assembled by inserting the barb adapter 2 into the opening of the tube 3. In some embodiments, the two half clamps 1 are placed around the outer surface of the flexible tube 3 with the barb adapter 2 inserted, and the positioning grooves 7 and teeth 14 on the inner surface of the half clamps 1 are used to position the half clamps 1 based on at least one feature of the outer surface of the barb adapter 2. In some embodiments, the two half clamps 1 form a shell around the barb adapter 2 inserted into the cavity of the flexible tube 3. In some embodiments, the half clamps 1 can only be assembled around the barb adapter 2 inserted in one direction into the flexible tube 3. In some embodiments, at least two ear clamps 4 are placed on the half clamps 1 and fitted into the dedicated recesses 9 on the outer surface of the half clamps 1. In some embodiments, the ear clamps 4 are clamped onto the half clamps 1. In some embodiments, the assembly of the flexible tube 3, the barb adapter 2, and the half clamps 1 is placed into a clamshell 12. In some embodiments, the inside diameter (ID) of the tube is in the range of about 1 / 8'' (0.125'') to about 1-1 / 4'' (1.25''). In some embodiments, the ID is about 1-1 / 4'' (1.25''). In some embodiments, the ID is about 1''. In some embodiments, the ID is about 3 / 4'' (0.75''). In some embodiments, the ID is about 5 / 8'' (0.625''). In some embodiments, the ID is about 1 / 2'' (0.5'').

[0023] II. Definition Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0024] As used herein, the term "barb fitting" refers to a connection device for tubing that has radial protrusions to allow fluid to pass and to reduce or prevent leakage at the connection.

[0025] As used herein, the term "biocontainer" refers to any manufactured or custom designed device or system that supports a biologically active environment.

[0026] As used herein, the term "fluid" refers to a substance having particles that move easily and change relative positions of the particles without separating into masses, and that readily succumb to pressure.

[0027] As used herein, the term "inlet" refers to a connection that transports fluids towards a biocontainer.

[0028] As used herein, the term "outlet" refers to a connection that transports fluid away from a biocontainer.

[0029] As used herein, the term "pressure tolerance" refers specifically to the resistance of a flexible tube to expansion and / or deformation.

[0030] As used herein, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise.

[0031] Equivalent All ranges of the express expressions listed herein include the ranges therebetween and can include or exclude the endpoints. Optional inclusive ranges are from the integer values ​​therebetween (or including one original endpoint) at the listed or next lower digit. For example, if the lower limit is 0.2, the optional inclusive endpoints can be 0.3, 0.4, ... 1.1, 1.2, etc., as well as 1, 2, 3, etc., and if the higher range is 8, the optional inclusive endpoints can be 7, 6, etc., as well as 7.9, 7.8, etc. One-sided boundaries such as 3 or more also include a consistent boundary (or range) starting from the integer value at the listed or one lower digit. For example, 3 or more includes 4 or 3.1 or more.

[0032] Throughout this specification, references to "one embodiment," "a particular embodiment," "one or more embodiments," "an embodiment," or "an embodiment" indicate that the described feature, structure, material, or characteristic is included in more than one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," "in embodiments," or "in one embodiment" are not necessarily all referring to the same embodiment throughout this specification.

[0033] All patent applications and patent publications and other non-patent literature cited herein are hereby incorporated by reference in their entirety in the entirety of the portion cited as if each individual publication or reference was specifically and individually indicated to be incorporated by reference herein as if fully set forth. Any patent application to which this application claims priority is also incorporated by reference herein in the manner described above for publications and references.

Claims

1. 1. A clamping system comprising: at least one flexible tube; a barb adapter that is inserted into an interior cavity of the at least one flexible tube to form a connection between the at least one flexible tube and an inlet or an outlet of a fluid system; Two semicircular half clamps surrounding the outside of the connection; a plurality of teeth on an inner surface of the half clamp; a positioning groove on an inner surface of the half clamp; at least one ear clamp that secures the half clamp around the connection; a sealing edge on an inner surface of the half clamp for radially compressing an outer surface of the at least one flexible tube; Equipped with A clamping system, wherein the teeth are circumferentially spaced apart from one another on the inner surface of the half clamp.

2. The clamping system of claim 1 , wherein the two half clamps are identical to each other.

3. 3. The clamping system of claim 1, wherein at least one ear clamp is within a recess on an outer surface of the half clamp.

4. The clamping system according to any one of claims 1 to 3, wherein at least one ear clamp is made of stainless steel.

5. The clamping system of any one of claims 1 to 4, further comprising a clamshell mating with at least a portion of an outer surface of the half clamp.

6. The clamping system of any one of claims 1 to 5, wherein the half clamps have locating ribs that can fit into grooves on the inner surface of the clamshell.

7. The clamping system of claim 6 , wherein an inner surface of the clamshell comprises a plurality of grooves.

8. The clamping system of claim 6 , wherein the at least one ear clamp is a plurality of ear clamps, the plurality of ear clamps being disposed within the plurality of grooves.

9. The clamping system of any one of claims 1 to 8, wherein at least one of the flexible tube, the barb adapter, and the half clamp are made from a polymeric material.

10. The clamping system according to any one of claims 1 to 9, wherein the inlet or outlet of the fluid system is selected from a flexible tube or a port of a biocontainer.

11. The clamping system according to any one of claims 1 to 10, wherein at least one flexible tube is a low durometer silicone tube.

12. A clamping system according to any one of claims 1 to 11, wherein the two ear clamps secure the half clamp around the connection.

13. The clamping system of any one of claims 1 to 11, wherein 3, 4, 5, 6, 7, 8, 9 or 10 ear clamps secure the half clamps around the connection.

14. 1. A method for increasing pressure resistance of a piping system, comprising: Inserting a barb adapter into a flexible tube; Sliding at least one ear clamp over a surface of the flexible tube in a longitudinal direction of the flexible tube; positioning the half clamp over the barb adapter and the flexible tube by matching a positioning groove on an inner surface of the half clamp with a protrusion of the barb adapter to surround the barb adapter and the flexible tube with the half clamp, the inner surface of the half clamp further including a plurality of teeth, the plurality of teeth being circumferentially spaced apart from one another on the inner surface of the half clamp; compressing the flexible tube against a sealing edge of an inner surface of the half clamp by clamping at least one ear clamp in a recess on an outer surface of the half clamp; A method comprising:

15. 15. The method of claim 14, further comprising: securing the half clamp within the clamshell by inserting a positioning rib of the half clamp into a groove on an inner surface of the clamshell, thereby increasing the resistance of the piping system.

16. 15. The method of claim 14, wherein the method increases the pressure resistance of the piping system to greater than 4 bar.

17. 15. The method of claim 14, wherein the pressure resistance of the piping system is increased to more than 2 bar.

18. A method according to any one of claims 14 to 17, wherein the pressure resistance of the piping system is increased to the pressure resistance of a stainless steel piping system.

19. The method of any one of claims 14 to 18, further comprising inserting at least one ear clamp into an additional groove on the inner surface of the clamshell.

20. The clamping system of any one of claims 1 to 13, wherein the teeth on the inner surface of the half clamp directly contact and radially compress the outer surface of the at least one flexible tube.

21. 20. The method of any one of claims 14 to 19, wherein tightening the at least one ear clamp further causes a plurality of teeth on an inner surface of the half clamp to radially compress an outer surface of the at least one flexible tube.

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