Pipe connector

Abstract

The disclosure herein relates to a flow path comprising a half clamp 1 having an inner surface that encircles a flexible tube 3 with a barb adapter 2 that when assembled can be placed within a clam shell to reduce or prevent deformation of the flexible tube.

Description

Technical Field

[0001] The embodiments disclosed herein relate to connectors. More specifically, the embodiments described herein relate to a clamping system having two half-clamps for connecting a flexible tube to a barbed adapter (also referred to as a barbed fitting). In some embodiments, these half-clamps are held in place by at least one ear clip and are placed within a clamshell retainer (referred to herein as a clamshell). Background Technology

[0002] Single-use systems (SUS) have become an important asset for biotechnology process development and scaling. While SUS currently used in the field improves manufacturing flexibility and reduces the cleaning costs of R&D and retrofitting, the connections to flexible tubing in these systems may struggle to withstand high-pressure operation. SUS components are typically made of polymeric materials. The pressure tolerance of plastic components (such as the flexible tubing of SUS) is generally lower than that of conventional stainless steel piping systems.

[0003] Currently, cable ties, hose clamps, or barbed clips are commonly used in the art to provide a secure connection to flexible tubing. However, these connections have been observed to have poor pull-out strength and provide inherent leakage paths under certain conditions. Robust and leak-proof connections are particularly important in the medical and pharmaceutical fields, such as those used in blood pumps, oxygen concentrators, sleep apnea devices, medical transport containers, and intravenous infusion bags, including connectors like Luer couplings, quick couplings, and sanitary couplings.

[0004] In flow paths made of low-hardness silicone tubing manifolds, it has been observed that when subjected to pressures exceeding two bar, the tubing expands beyond the shell, leading to tubing deformation and potential leakage. For example, when subjected to four bar of pressure, the silicone tubing has been observed to expand beyond the shell at all external connections. Expansion was also observed at barbed adapters that were at least partially inserted into the tubing used for external connections.

[0005] The system that provides a unique, single-use flow path housed in a hardware shell represents an inventive advancement in the art, wherein the hardware shell enables membrane or pipe flow paths to withstand high-pressure applications up to or greater than four bar. Summary of the Invention

[0006] The embodiments described herein overcome the shortcomings of the prior art, including some of the embodiments disclosed herein, which provide flow paths with leak-proof connections and semi-clamps to reduce or prevent pipe expansion and / or deformation. Furthermore, in some embodiments, the flow paths described herein are suitable for high-pressure applications where the pressure rating of each component of the flow path individually exceeds the pressure rating.

[0007] Some embodiments described herein provide a flow path comprising: at least one flexible tube; a barbed adapter inserted into the lumen of at least one flexible tube to form a connection between at least one flexible tube and an inlet or outlet; two semicircular half-clamps surrounding the outside of the connection; a plurality of teeth on the inner surface of the half-clamps; positioning grooves on the inner surface of the half-clamps; at least one ear clamp securing the half-clamps around the connection; and a sealing edge on the inside of the half-clamps for radially compressing the outer surface of at least one flexible tube.

[0008] In some embodiments, the two half-clamps of the flow path are identical. In some embodiments, at least one ear clip is located within a recess on the outer surface of the half-clamp. In some embodiments of the flow path, at least one ear clip is made of metal (e.g., stainless steel). In some embodiments, the flow path further includes a clamshell that abuts at least a portion of the outer surface of the half-clamp. In some embodiments, the outer surface of the half-clamp has positioning ribs that can fit into grooves in the inner surface of the clamshell. In some embodiments, protrusions on the ear clip fit into grooves in the inner surface of the clamshell. In some embodiments, the inner surface of the clamshell includes more than one groove. In some embodiments, at least one ear clip is located in more than one groove. In some embodiments, at least one of the flexible tube, barbed adapter, and half-clamp is made of a polymeric material.

[0009] In some embodiments, the inlet and / or outlet are selected from flexible tubes or ports of the biocontainer. In some embodiments, the flexible tube is a low-hardness silicone tube. In some embodiments, two ear clips secure the semi-clamp around the connection. In some embodiments, three, four, five, six, seven, eight, nine, or ten ear clips secure the semi-clamp around the connection.

[0010] Some embodiments described herein provide a method for increasing the pressure tolerance of a piping system, the method comprising: inserting a barbed adapter into a flexible tube; sliding at least one lug clip on the flexible tube; positioning the half-clamp on the barbed adapter and the flexible tube by matching a positioning groove on the interior of the half-clamp with a protrusion of the barbed adapter, thereby enclosing the barbed adapter and the flexible tube with the half-clamp; compressing the pipe by tightening the lug clip at a recess on the outer surface of the half-clamp using a sealing edge on the interior of the half-clamp; and securing the half-clamp to the shell by inserting a positioning rib of the half-clamp into a groove on the inner surface of the shell, thereby increasing the pressure tolerance of the piping system.

[0011] In some embodiments, the method increases the pressure tolerance to more than four bar. In some embodiments of the method, the pressure tolerance is increased to more than two bar. In some embodiments of the method, the pressure tolerance is increased to less than four bar. In some embodiments of the method, the pressure tolerance is increased to the pressure tolerance of a stainless steel piping system. In some embodiments, the method further includes inserting at least one ear clip into an additional groove on the inner surface of the clamshell. Attached Figure Description

[0012] Figure 1A Exploded views of some embodiments of the semi-clamp are provided. Figure 1B Views of some embodiments of an assembled set of semi-clamps are provided.

[0013] Figure 2A Exploded views of some embodiments of the semi-clamp are provided. Figure 2B Views of some embodiments of an assembled set of semi-clamps are provided.

[0014] Figure 3 An exploded view of some embodiments of the flow path is provided.

[0015] Figure 4 Views of some embodiments of fully assembled flow paths are provided.

[0016] The accompanying drawings illustrate some embodiments of the disclosure herein and should therefore not be considered as limiting the scope, as the invention can allow for other equally effective embodiments. It should be understood that elements and features of any embodiment can be found in other embodiments without further explanation, and where possible, the same reference numerals have been used to indicate comparable elements common to the drawings. Detailed Implementation

[0017] This disclosure describes several embodiments of flow paths including a semi-clamp having an inner surface surrounding a flexible tube connection with a barbed adapter. In some embodiments, the flexible tube is connected to a gaseous fluid source, a liquid fluid source, a fluid delivery location, or an additional flexible tube that allows gaseous or liquid fluid to flow through the flexible tube. Alternatively, in some embodiments, the flexible tube delivers gaseous or liquid fluid into a biocontainer.

[0018] Now turn to the attached image. Figure 1A and Figure 2A Exploded views of some embodiments of the half-clamps 1a and 1b are provided. Figure 1B and Figure 2B Views of some embodiments of an assembled set of semi-clamps 1a, 1b are provided. Figure 1A , Figure 1B , Figure 2A and Figure 2BAs shown, in some embodiments, the flow path that minimizes pipe expansion and / or deformation includes two half-clamps 1 (denoted as 1a and 1b, respectively). In some embodiments, the two half-clamps 1 are identical. In some embodiments, the half-clamps 1 are clamped by an external force or device (e.g., at least one ear clamp 4 (see...)). Figure 3 and Figure 4 The two halves are held together. Alternatively, in some embodiments, one half-clamp 1a includes a male component and the other half-clamp 1b includes a female component, wherein the female component is fitted within the male component to secure the halves together. In some embodiments, the male and female components interlock to join the halves together at the contact surface 10. Alternatively, in some embodiments, the two halves 1 are connected by a hinge (not shown).

[0019] In some embodiments, when the flexible tube 3 is subjected to pressures up to four bar, the semi-clamp 1 prevents tube deformation by forming a robust support "shell" around the outer surface of the flexible tube 3. In some embodiments, the semi-clamp 1 provides a complete radial seal around the outer surface of the flexible tube 3. In some embodiments, this complete radial seal is achieved by compressing the tube using the sealing edge 5 on the inner surface of the semi-clamp 1 when the stainless steel ear clip 4 is closed. In some embodiments, expansion of the tube 3 is prevented by positioning ribs 6 located on the outer surface of the semi-clamp 1 within an inner groove 13 on the inner surface of the clamshell retainer 12. In some embodiments, positioning grooves 7 and friction ribs 8 on the inner surface of the semi-clamp 1 also contribute to reducing tube displacement. In some embodiments, the friction ribs 8 do not span the entire circumference of the inner surface of the semi-clamp 1. In some embodiments, positioning grooves 7 and teeth 14 on the inner surface of the semi-clamp 1 also contribute to reducing tube displacement. In some embodiments, the outer surface of the semi-clamp 1 has a dedicated groove 9 to position the ear clip 4 during assembly of the flow path.

[0020] like Figure 3As shown, in some embodiments, the barb adapter 2 includes at least one extension end 11. In some embodiments, the extension end 11 is a triple clamp (TC) connector. In some embodiments, the TC connector is connected to other TC ends. In some embodiments, the tapered end of the barb adapter 2 is inserted into the opening of the flexible tube 3 to contact 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, the contact between the tapered end of the barb adapter 2 and the inner surface of the flexible tube 3 forces fluid through the opening of the barb adapter 2 and prevents fluid from flowing around the peripheral edge of the barb adapter 2. For example, at least a portion of the barb adapter 2 may have an outer surface whose circumference is the same as or larger than the circumference of the inner surface of the flexible tube 3 to facilitate contact, such as a tight 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% larger than the circumference of the inner surface of the flexible tube 3. In some embodiments, the contact between the barb adapter 3 and the inner surface of the flexible tube 3 spans the entire circumference of the inner surface of the flexible tube 3. In some embodiments, the contact between the barb adapter 2 and the inner surface of the flexible tube 3 spans the entire circumference of the outer surface of the barb adapter 3.

[0021] 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 can be heat-welded to a propylene or ethylene bag, such as a disposable biological container. In some embodiments, the non-metallic material is selected from polypropylene, silicone, thermoplastic elastomers (TPE), and thermoplastic rubber (TPR) approved by the U.S. Food and Drug Administration (FDA). 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 may be selected from the group consisting of plastic welding or heat sealing, such as ultrasonic welding, laser welding, welding using infrared radiation, or thermal welding.

[0022] In some embodiments, the half-clamp 1 is held in place by at least one ear clip 4. In some embodiments, the half-clamp 1 is held in place by two ear clips 4. In some embodiments, the half-clamp 1 is held in place by more than two ear clips 4. For example, some embodiments may include three, four, five, six, seven, eight, nine, or ten ear clips 4. In some embodiments, at least one ear clip 4 is made of a material selected from stainless steel or plastic.

[0023] like Figure 4 As shown, in some embodiments, the flexible tube 3 (e.g., with a stiffness similar to DOWN) is surrounded by a flexible tube 3. An assembly of circumferentially circumferentially clamps 1 of a low-hardness silicone tube (similar to Pharma-50 tubing) is integrated into a shell 12 to withstand a maximum pressure of four bar and prevent the flexible tube 3 from expanding. In some embodiments, the half-clamps 1 surround the outer surface of the flexible tube 3 having barbed adapters 2. In some embodiments, the half-clamps 1 contact each other to surround at least a portion of the outer surface of the flexible tube 3, thereby causing the barbed adapters 2 to contact the inner surface of the flexible tube 3.

[0024] Some embodiments described herein enable the flow path to withstand pressure conditions exceeding the specified pressure rating of the flexible tube 3 independently, and prevent tube deformation. In some embodiments, the semi-clamp 1 reduces or prevents fluid leakage at the tube connection. The robust and leak-proof connection of the flexible tube 3 is important in medical, pharmaceutical, automotive, industrial, and bioprocessing fields. In some embodiments, liquid is not trapped in the connection and does not lead to, for example, bacterial growth.

[0025] I. Assembly

[0026] In some embodiments, the flow path is assembled by inserting the barb adapter 2 into the opening of the pipe 3. In some embodiments, the two half-clamps 1 are positioned around the outer surface of the flexible tube 3 to which the barb adapter 2 is inserted, based on at least one feature on the outer surface of the barb adapter 2, using positioning grooves 7 and teeth 14 on the inner surface of the half-clamp 1. 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 may be assembled only around the barb adapter 2 inserted into the flexible tube 3 in one direction. In some embodiments, at least two ear clips 4 are placed on the half-clamps 1 and integrated into a dedicated groove 9 on the outer surface of the half-clamps 1. In some embodiments, the ear clips 4 are fastened to the half-clamps 1. In some embodiments, the flexible tube 3, the barb adapter 2, and the half-clamps 1 assembly are placed in a shell 12. In some embodiments, the inner diameter (ID) of the pipe 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”).

[0027] II. Definition

[0028] 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.

[0029] As used in this article, the term "barbed fitting" refers to a connection device for pipes that allows fluid to pass through and has radial protrusions to reduce or prevent leakage in the connection.

[0030] As used in this article, the term "biocontainer" refers to any manufactured or engineered device or system that supports a biologically active environment.

[0031] As used in this article, the term "fluid" refers to a material containing particles that are easily moved and change their relative positions without separating the matter and are easily yielded to pressure.

[0032] The term "inlet" as used in this article refers to the connector that directs fluid toward the biocontainer.

[0033] As used in this article, the term "exit" refers to the connector that transports fluid away from the biological container.

[0034] As used in this article, the term "pressure tolerance" refers to the resistance to expansion and / or deformation, particularly the aforementioned resistance of flexible tubes.

[0035] The singular forms “a,” “an,” and “the” used in this document include the plural forms, unless the context clearly indicates otherwise.

[0036] Equivalent cases

[0037] All ranges of formulations described herein include the ranges between them, and may or may not include endpoints. Optionally included ranges are integer values ​​(or include a primary endpoint) within the stated order of magnitude or the next smaller order of magnitude. For example, if the lower limit is 0.2, optional included endpoints could be 0.3, 0.4, ... 1.1, 1.2, etc., and 1, 2, 3, etc.; if the upper limit is 8, optional included endpoints could be 7, 6, etc., and 7.9, 7.8, etc. A single boundary (e.g., 3 or more) also includes a consistent boundary (or range) that begins with an integer value at or below the stated order of magnitude. For example, 3 or more includes 4 or 3.1 or more.

[0038] References to "one embodiment," "some embodiments," "one or more embodiments," "some embodiments," or "an embodiment" in this patent specification indicate that the stated features, structures, materials, or characteristics are included in some embodiments of this disclosure. Therefore, the appearance of phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," "in some embodiments," or "in one embodiment" in this patent specification does not necessarily refer to the same embodiment.

[0039] All patent applications, patents, and other non-patent references cited in this patent specification are incorporated herein by reference in their entirety, as if each individual publication or reference were expressly and individually indicated to be fully set forth in connection with this document. Any patent application claiming priority to this application is also incorporated herein by reference in the foregoing manner for disclosure and reference.

Claims

1. A flow path, comprising: At least one flexible tube; A barbed adapter is inserted into the inner 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 surround the outside of the connection; Multiple teeth located on the inner surface of the semi-clamp; A positioning groove located on the inner surface of the semi-clamp; At least one ear clip, the at least one ear clip securing the half clamp around the connection; and A sealing edge located inside the semi-clamp is used to radially compress the outer surface of the at least one flexible tube.

2. The flow path as described in claim 1, wherein, The two half-clamps are identical.

3. The flow path as described in any one of claims 1 and 2, wherein, The at least one ear clip is located within a recess on the outer surface of the half clamp.

4. The flow path as described in any one of claims 1 and 2, wherein, The at least one ear clip is made of stainless steel.

5. The flow path as described in any one of claims 1 and 2, wherein, The flow path also includes a clam shell that abuts at least a portion of the outer surface of the semi-clamp.

6. The flow path as described in claim 5, wherein, The semi-clamp has a positioning rib that can be fitted into a groove on the inner surface of the clam shell.

7. The flow path as described in claim 6, wherein, The inner surface of the clam shell includes more than one groove.

8. The flow path as described in claim 7, wherein, The at least one ear clip is located within the more than one groove.

9. The flow path as described in any one of claims 1 and 2, wherein, At least one of the flexible tube, the barbed adapter, and the semi-clamp is made of a polymer material.

10. The flow path as described in any one of claims 1 and 2, wherein, The inlet or outlet is selected from the flexible tube or port of the biological container.

11. The flow path as described in any one of claims 1 and 2, wherein, The flexible tube is a low-hardness silicone tube.

12. The flow path as described in any one of claims 1 and 2, wherein, Two ear clips secure the semi-clamp around the connection.

13. The flow path as described in any one of claims 1 and 2, wherein, Three, four, five, six, seven, eight, nine, or ten ear clips secure the semi-clamp around the connection.

14. A method for increasing the pressure tolerance of a piping system, the method comprising: Insert the barbed adapter into the flexible tube to form a connection between the flexible tube and the inlet or outlet; At least one ear clip slides on the flexible tube; The half-clamp is positioned on the barb adapter and the flexible tube by matching a positioning groove on the inside of the half-clamp disposed around the connection with a protrusion of the barb adapter; thereby utilizing the half-clamp around the barb adapter and the flexible tube. as well as The pipe is compressed by tightening the ear clip at the recess on the outer surface of the half clamp, utilizing the sealing edge on the inside of the half clamp.

15. The method of claim 14, wherein, The method further includes fixing the semi-clamp into the shell by inserting the positioning ribs of the semi-clamp into a groove on the inner surface of the shell, thereby increasing the pressure tolerance of the piping system.

16. The method of claim 14, wherein, The method increases the pressure tolerance to more than four bar.

17. The method of claim 14, wherein, The pressure tolerance has increased by more than two bar.

18. The method according to any one of claims 14-17, wherein, The pressure tolerance was increased to the pressure tolerance of the stainless steel piping system.

19. The method of claim 15, wherein, The method further includes inserting the at least one ear clip into an additional groove on the inner surface of the clam shell.

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