Biocompatible accessory assembly and fluid connection system

Abstract

The invention relates to a biocompatible fitting assembly and a fluid connection system. The fluid connection system includes a threaded fastener and a fitting assembly. The threaded fastener is a universal threaded fastener and can be used together with various pipelines with different outer diameters. The fitting assembly includes a locking ring and a ferrule sized and shaped to fit within a bore of the locking ring. When the fluid connection system is assembled, the end of the locking ring and the end of the ferrule protrude beyond the end of the fitting assembly. In some embodiments, the locking ring is symmetrical about a plane perpendicular to its longitudinal axis such that the locking ring is positioned on the pipe in either direction. The locking ring is received in a fitting pocket of the fitting assembly. In other embodiments, the locking ring has a tapered feature at an end that engages a tapered feature of the threaded fastener to assist in centering the locking ring within the threaded fastener. In some embodiments, the ferrule is also symmetric about the longitudinal axis such that the ferrule is positioned on the pipe in either direction.

Description

Technical Field

[0001] The present disclosure relates generally to accessory assemblies and fluid connection systems, such as those used to connect components of analytical instrument systems, and more particularly to biocompatible accessory assemblies used in conjunction with analytical instrumentation, bioprocesses and fluids, diagnostics, and life sciences. Background Art

[0002] There are a wide variety of instruments and systems that can be used to process biological samples, assist in diagnosing medical conditions, manipulate DNA, and the like. The present disclosure relates to novel and improved accessory components that are used for such applications as described above, as well as flow cytometry, proteomics, and analytical and scientific instruments. Although not limited to liquid chromatography (LC) applications, LC is used in the present disclosure as an example of the type of analytical system used in conjunction with the analysis of biological samples, in which the novel and improved accessory components described below can be used. Although the following discussion focuses on liquid chromatography, it will be noted that what is said about LC systems (most if not all) has also been applied to gas chromatography, ion chromatography, and other types of analytical instrument (AI) systems and methods. Other such AI systems and methods can, for example, include chip labs, printing, sensors, microchromatographs, biochemical detection, mass spectrometry, biosensing, drug discovery, drug delivery, molecular separation, proteomics, fuel cells, optics and optofluidics, and research tools.

[0003] LC is a well-known technique for separating the constituent elements in a given sample. In a conventional LC system, a liquid solvent (referred to as a "mobile phase") is introduced from a reservoir and pumped through the LC system. The mobile phase leaves the pump under pressure. The mobile phase then travels to a sample injection valve via a pipeline. As the name implies, the sample injection valve allows the operator to inject a sample into the LC system, where the sample will be carried along with the mobile phase.

[0004] In conventional LC systems, the sample and mobile phase pass through one or more filters and often through a guard column before reaching the guard column. A typical column is usually composed of a steel tube that has been packed with a "packing" material. The "packing" is composed of a granular material "packed" in the column. The "packing" is usually composed of silica or polymer-based particles, which are often chemically combined with chemical functionality. The packing material is also called a stationary phase. One of the basic principles of separation is that the mobile phase passes through the stationary phase continuously. When the sample is carried through the column (along with the mobile phase), the various components (solutes) in the sample migrate through the packing in the column at different rates (i.e., there is a differential migration of solutes). In other words, the various components in the sample will move through the column at different rates. Due to the different movement rates, as the components move through the column, the components gradually separate. Differential migration is affected by factors such as the composition of the mobile phase, the composition of the stationary phase (i.e., the material "packed" to the column) and the temperature at which the separation occurs. Such factors will therefore affect the separation of the various components of the sample.

[0005] Once the sample (whose components have now been separated) leaves the column, the sample flows along with the mobile phase past a detector. The detector detects the presence of specific molecules or compounds. Two general types of detectors are used in LC applications. One type of detector measures changes in certain overall physical properties of the mobile phase and sample (e.g., the refractive index of the mobile phase and sample). Another type of detector measures only certain properties of the sample (e.g., absorption of ultraviolet radiation). Essentially, a typical detector in an LC system can measure and provide an output of the sample components expressed as mass per unit volume (e.g., grams per milliliter) or mass per unit time (e.g., grams per second). From such an output signal, a "chromatogram" can be provided; the chromatogram can then be used by an operator to determine the chemical components present in the sample.

[0006] In addition to the above components, LC systems will often include filters, check valves, guard columns, or the like to prevent samples from contaminating or damaging the LC system. For example, an inlet solvent filter can be used to filter out particles from the solvent (or mobile phase) before it reaches the pump. A guard column is often placed before the analytical column or the preparative column; that is, the main column. The purpose of such a guard column is to "protect" the main column by absorbing unwanted sample components that might otherwise be irreversibly bound to the analytical column or the preparative column.

[0007] In practice, various components in an LC system may be connected by an operator to perform a given task. For example, the operator will select the appropriate mobile phase and column, and then connect the supply of the selected mobile phase and the selected column to the LC system prior to operation. Each connection must be able to withstand the typical operating pressure of the system. If the connection is too weak, the system will leak. Since the type of solvent sometimes used as a mobile phase is often toxic, and since it is often expensive to obtain and / or prepare many samples for use, any such connection failure is a serious problem.

[0008] In view of the need for leak-free connections, conventional connections have been made with stainless steel pipes and stainless steel end fittings. However, it has recently been recognized that the use of stainless steel components in LC systems has potential disadvantages in situations involving biological samples or bioprocesses. For example, components in the sample can attach themselves to the wall of the stainless steel pipe. This brings problems, because if some of the components or ions of the sample are retained in the pipe without passing through the detector, the measurement results of the detector for a given sample (and thus, the results of the chromatogram in the LC system) will not accurately reflect the sample. However, perhaps more worrying is the fact that ions from the stainless steel pipe will break away from the pipe and flow over the detector, thereby causing potential erroneous results. In addition, ions can easily combine with biological compounds of interest. Therefore, it is necessary to achieve a "biocompatible" connection by using a material that is chemically inert to such "biological" samples and bioprocesses.

[0009] In many applications where selector / injector valves are used to direct fluid flow, and especially in liquid chromatography and gas chromatography, the volume of fluid is relatively small. This is especially true when liquid chromatography or gas chromatography is being used as an analytical method rather than a preparative method. This method often uses a capillary column and is commonly referred to as capillary chromatography. In capillary chromatography, both gas chromatography and liquid chromatography, it is often desirable to minimize the internal volume of the selector or injector valve. One of the reasons is that a valve with a larger volume will accommodate a relatively large volume of liquid, and when a sample is injected into the valve, the sample will be diluted, thereby reducing the resolution and sensitivity of the analytical method.

[0010] Microfluidic analysis processes also involve smaller sample sizes. As used herein, the sample volume considered to be related to microfluidic technology can be in the range of a volume from as low as only a few picoliters (picoliter) or so to a few milliliters or so, while more traditional LC techniques, for example, have historically often involved samples with a volume of about 1 microliter to about 100 milliliters. Therefore, microfluidic technology as described herein relates to such a volume, that is, the size of the volume is one or more orders of magnitude smaller than the size of the volume in the case of traditional LC techniques. Microfluidic technology can also be expressed as those technologies involving a fluid flow rate of about 0.5 ml / min or less.

[0011] As previously mentioned, liquid chromatography (and other analyses) typically includes several components. For example, such a system may include: a pump; an injection valve or autosampler for injecting the analyte; a pre-column filter for removing particulate matter in the analyte solution that could clog the column; a packed bed for retaining irreversibly adsorbed chemical materials; the column itself; and a detector for analyzing the carrier fluid as it leaves the column.

[0012] These various components and sections of tubing are all typically connected to each other by threaded fittings. Fittings for connecting various LC and other types of system components and sections of tubing are disclosed in prior patents, such as U.S. Patent Nos. 5,525,303; 5,730,943; and 6,095,572, the disclosures of which are all incorporated herein by reference as if fully set forth herein. Often, a first internally threaded fitting is sealed to a first component by means of a ferrule or similar sealing device. The first fitting is threadably connected to a second fitting having a corresponding external fitting by hand or by using one or more wrenches through multiple turns, which in turn is sealed to the second component by a ferrule or other seal. Disconnecting these fittings for component replacement, maintenance, or reconfiguration often requires the use of one or more wrenches to loosen the fitting. Although one or more wrenches may be used, other tools such as pliers or other clamping and holding tools are sometimes used. It will be understood that as used herein, the term "LC system" in its broad sense is intended to include all equipment and components in a system used in conjunction with liquid chromatography, whether they are made of only a few simple components, or of many complex components controlled by a computer, or the like. It should be noted that an LC system is a type of analytical instrument (AI) system. Although the discussion herein focuses on liquid chromatography, much of what is said also applies to other types of AI systems and methods, as well as bioprocesses and systems for these processes.

[0013] One example of a flat bottom or face seal connection assembly is provided by U.S. Patent No. 8,696,038, issued to Nienhuis on April 15, 2014, entitled "Flat Bottom Fitting Assembly". Nienhuis teaches a type of flat bottom assembly that includes a flat side ferrule, and in which the assembly including the ferrule and the tube can be pressed against the flat bottom port. Another example of a flat bottom or face seal connection assembly is provided by published U.S. Patent Application No. 2012 / 0024411, published on February 2, 2012, entitled "Biocompatible Tubing for Liquid Chromatography Systems", which was filed by Hahn et al. The patent application published by Hahn et al. describes a tubing having an inner layer and an outer layer, and wherein the inner layer can be a biocompatible material such as polyetheretherketone (PEEK) and the outer layer can be a different material, and wherein the end of the tubing can be flared or otherwise adapted to have a larger outer diameter than the rest of the tubing.

[0014] One problem with conventional ferrules used with tapered ports is that the torque required for deformation / deflection is typically above finger-tight levels. It would be desirable to remove tools from the laboratory by eliminating the need for tools to make and break fluid connections, and it would be advantageous to have fittings that can be connected simply with the fingers rather than with tools.

[0015] U.S. Patent Nos. 5,525,303, 5,730,943, 6,056,0331, 6,095,572, 6,056,331, 7,311,502, 8,696,038, European Patent No. EP2564104, and published U.S. Patent Application Nos. 2005 / 0269264, 2007 / 0283746, 2012 / 0024411, 2012 / 0061955, and 2013 / 0043677 are hereby incorporated by reference as if fully set forth herein. Summary of the invention

[0016] Therefore, an object of the present disclosure is to provide a fluid connection system, the fluid connection system includes a threaded fastener and a fitting assembly, the threaded fastener and the fitting assembly reduce the required installation force. Another object of the present disclosure is to provide a fluid connection system, wherein the axial force required for creating an effective seal can be manually generated under minimum torque and without the use of tools. Another object of the present disclosure is to provide a fluid connection system, the fluid connection system can be quickly and easily connected and disconnected with various pipes and ports without damaging the assembly. Finally, the fluid connection system can be biocompatible (e.g., completely free of metal). In certain embodiments, one or more components of the fitting assembly (e.g., ferrule and / or locking body) can be symmetrical so that the components can be assembled in multiple orientations (e.g., facing either direction) to reduce errors and assembly time. The components of the fitting assembly can also be butted against each other, thereby reducing material creep while providing a biocompatible assembly. The threaded fastener of the system can be a universal threaded fastener, which can be used across a variety of pipe sizes, while also providing appropriate centering and ferrule heights to ensure easy installation under various needs.

[0017] In one embodiment of the present disclosure, a fluid connection system includes a fitting assembly, the fitting assembly includes a biocompatible ferrule system, and the biocompatible ferrule system has a ferrule and a locking ring. The locking ring can have a larger opening (defined by the inner diameter of the locking ring) on ​​at least one end so that the ferrule can be pressed into the opening of the locking ring. In some aspects, the inner diameter of the locking ring can be consistent in the central area, which can allow the locking ring to be oriented in all directions while maintaining the same clamping effect, thereby reducing errors and assembly time. In addition, the ferrule can be designed to be symmetrical so that the ferrule can be assembled in any direction with the same result, thereby further reducing errors and assembly time. In some aspects, the locking ring can be formed by a polymer, such as but not limited to a biocompatible material, including a biocompatible polymer, such as a polyetheretherketone (PEEK) polymer. In some aspects, the locking ring can be formed by an enhanced PEEK polymer for improving the rigidity of the locking ring. The ferrule can also be formed of a biocompatible material, for example, a biocompatible polymer, such as but not limited to a PEEK polymer. In some aspects, the ferrule is formed of an unfilled PEEK polymer. The configuration of the ferrule and the locking body minimizes the ability of the ferrule to be damaged due to overtorque, and also minimizes stress relaxation and creep, which prevents the need for multiple tightening cycles. The ferrule body can be produced via injection molding or by extruding the material into a tube and by cutting the tube into the final desired length, but other suitable manufacturing means can also be used. In some aspects, one or more of the ferrule and the locking ring include polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA, also known as perfluoroalkylethylene), polychlorotrifluoroethylene (PCTFE) or at least one of the filling materials. For example, one or more of the above materials can include carbon fiber (e.g., carbon fiber reinforced PEEK) and / or a polymer material, or a combination of some or all of the above materials. The polymer material may include a composite material or a woven material, for example, a polymer material including or woven with fibers such as carbon fibers, steel fibers, basalt fibers, or the like. The carbon, carbon fibers, steel fibers, or other fibers (e.g., basalt fibers) may comprise 5%, 10%, 20%, 30%, 40%, or 50% by weight or by volume of the reinforcement material. The fibers may include the same or different material as the polymer containing the fibers.The threaded fastener of the fluid connection system may be a universal threaded fitting that delivers an optimal fitting engagement with the fitting assembly across a variety of port configurations (eg, shallow ports, machined threaded ports, and / or different sized pipes).

[0018] In certain aspects, the fluid connection system is assembled by sliding a threaded fastener and then a locking ring onto a desired pipe and then pressing a ferrule onto the end of the pipe. The threaded fastener includes a feature that helps position and center the fitting assembly and the pipe so that the feature is concentric with the mating threaded fluid port through-hole. In certain embodiments, for example, in a fitting assembly used with a pipe having an outer diameter of 1 / 16", the locking ring and the ferrule body are centered via their mating within an internal pocket on the threaded fastener. In other embodiments, for example, in a fitting assembly used with a pipe having an outer diameter of 1 / 8", centering can be provided by mating a female tapered feature on the threaded fastener with a male tapered feature on the locking ring. The resulting fitting assembly can provide an optimal amount of ferrule extending beyond the end of the threaded fastener so that the threads of the threaded fastener do not bottom out in the port while providing proper threaded engagement in shallow fluid ports. The fitting assembly can then be loaded into a mating port or pressurizing mechanism to press the locking ring onto the ferrule so that the ends of the locking ring and the ferrule end up flush or nearly flush with the ends of the internal pipe and are securely pressed together to create a seal.

[0019] Each of the fitting assembly, pipeline assembly and analytical instrument system of the present disclosure is suitable for providing at least one sealed connection for a fluid connection, in which the fluid has a pressure between 0psi and 500psi, between 50psi and 400psi, between 0psi and 200psi and / or between 100psi and 250psi. This sealed connection can be completed by the user without the use of tools and only using less than about 2 inch pounds or less of installation torque without the use of tools. This is significantly less than the existing design, which requires 2 inch pounds or more and typically requires the use of tools to achieve full performance. Each fitting assembly of the present disclosure is capable of withstanding torque levels that exceed the torque levels they are usually subjected to during installation, for example, in a standard port, the disclosed fitting assembly is capable of withstanding torques of up to 5 inch pounds without obvious signs of failure, and the pressure capacity is not reduced after testing. The design of the fitting assembly of the present disclosure makes the sealing performance largely independent of most torque values ​​applied by hand. Therefore, the performance of the seal of the disclosed fitting assembly will be relatively constant over a wide range of torque applications.

[0020] These and many other features, objects, and advantages of the present disclosure will become apparent to those skilled in the art from a review of the detailed description, claims, and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG1 is a block diagram of a conventional liquid chromatography system.

[0022] Figure 2 is a perspective view of one embodiment of a fluid connection system including a threaded fastener and a fitting assembly.

[0023] Figure 3 yes Figure 2 An exploded side view of a portion of a fluid connection system.

[0024] Figure 4 yes Figure 2 A perspective view of the locking ring of the fitting assembly.

[0025] Figure 5 yes Figure 4 A cross-sectional view of the locking ring.

[0026] Figure 6 yes Figure 2 A perspective view of the ferrule of the fitting assembly.

[0027] Figure 7 yes Figure 2 A cross-sectional view of a fluid connection system.

[0028] Figure 8is a cross-sectional side view of the fluid connection system of FIG. 1 coupled to a port.

[0029] Fig. 9 is a perspective view of another embodiment of a fluid connection system including a threaded fastener and a fitting assembly.

[0030] Fig.10 yes Fig. 9 An exploded side view of a portion of a fluid connection system.

[0031] Fig.11 yes Fig. 9 A perspective view of the locking ring of the fitting assembly.

[0032] Fig.12 yes Fig.11 A cross-sectional view of the locking ring.

[0033] Fig.13 yes Fig. 9 A perspective view of the ferrule of the fitting assembly.

[0034] Fig.14 yes Fig. 9 A cross-sectional view of a fluid connection system.

[0035] Fig.15 is connected to the port Fig. 9 A cross-sectional side view of a fluid connection system. DETAILED DESCRIPTION

[0036] As described above, there are a wide variety of instruments and systems that can be used to analyze, process, and otherwise use biological samples, assist in diagnosing medical conditions, manipulate DNA, and the like. The present disclosure relates to novel and improved accessory assemblies for use in such applications. The improved accessory assemblies disclosed herein can be used in such systems and applications, i.e., the systems and applications are used for flow cytometry, gene sequencing, proteomics, systems and processes for manufacturing and / or analyzing biologics and biosimilars, and the like. In addition, the improved accessory assemblies described and shown herein can be used in conjunction with systems and processes for health applications, including clinical and diagnostic instruments and systems, such as, but not limited to, fluid instillation devices, in vitro diagnostics, bioprocessing and pharmaceutical systems, clinical chemistry, immunoassays, hematology, molecular diagnostics, clustered regularly interspaced short palindromic repeats ("CRISPR"), sample preparation, space biology, polymerase chain reaction ("PCR"), and HbA1c detection and processing, and the like. Although not limited to liquid chromatography (LC) applications, LC is used in the present disclosure as an example of a type of analytical instrument system that can be used in conjunction with the analysis of biological samples, in which the novel and improved accessory assemblies described below can be used. Although the following discussion focuses on liquid chromatography, it should be understood that much of what is said about LC systems also has application to gas chromatography, ion chromatography, and other types of analytical instrumentation (AI) systems and methods, as well as the systems and processes described above. Other such AI systems and other processes and applications that can use the accessory components of the present disclosure can include, for example, chip labs, printing, sensors, microchromatographs, biochemical detection, mass spectrometry, biosensing, drug discovery, drug delivery, molecular separations, proteomics, flow batteries, fuel cells, optics and optofluidics, and research tools.

[0037] In FIG. 1 , a block diagram of the basic elements of a conventional liquid chromatography (LC) system is provided. A reservoir 101 contains a solvent or mobile phase 102. A conduit 103 connects the mobile phase 102 in the reservoir 101 to a pump 105. The pump 105 is connected to a sample injection valve 110, which in turn is connected to a first end of a guard column (not shown) via a conduit. The second end of the guard column (not shown) is in turn connected to a first end of a main column 115. The second end of the main column 115 is in turn connected to a detector 117 via a conduit. After passing through the detector 117, the mobile phase 102 and the sample injected via the injection valve 110 are extended into a second reservoir 118, which contains chemical waste 119. As described above, the sample injection valve 110 is used to inject a sample of the material to be studied into the LC system. The mobile phase 102 flows through a conduit 103, which is used to connect the various elements of the LC system together.

[0038] When a sample is injected into the LC system via the sample injection valve 110, the sample is carried by the mobile phase through the tubing into the column 115. As is well known in the art, the column 115 contains a packing material for separating the constituent elements of the sample. After leaving the column 115, the sample (as separated via the column 115) is then carried to the detector 117 and enters the detector 117, which detects the presence or absence of various chemical substances. The information obtained by the detector 117 can then be stored and used by the operator of the LC system to determine the constituent elements of the sample injected into the LC system. Those skilled in the art will understand that FIG. 1 and the foregoing discussion only provide a brief overview of a simple LC system that is conventional and well known in the art, as shown and described in U.S. Patent No. 5,472,598 issued to Schick on December 5, 1995, which is incorporated herein by reference as if fully set forth herein. Those skilled in the art will also appreciate that while the discussion herein focuses on LC systems, other analytical systems may be used in conjunction with various embodiments of the present invention, for example, mass spectrometry, microflow chromatography, nanoflow chromatography, nanoscale liquid chromatography, capillary electrophoresis, or reversed-phase gradient chromatography systems.

[0039] Preferably, for a biocompatible and metal-free fluid system, the various components that will contact the effluent or sample to be analyzed (unless otherwise specified) are made of a synthetic polymer polyetheretherketone, which is commercially available from Victrex under the trademark "PEEK". The polymer PEEK has the advantage of providing a high degree of chemical inertness and thus biocompatibility; the polymer PEEK is chemically inert to most common solvents used in fluid applications (such as acetone, acetonitrile and methanol, to name a few). PEEK can also be processed by standard processing techniques to provide a smooth surface. It should be noted that in some applications, other polymers are desired. In certain aspects, one or more components of a biocompatible fluid system may include at least one of polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA, also known as perfluoroalkylethylene) or polychlorotrifluoroethylene (PCTFE). In any one or more of the aforementioned polymers, additional reinforcing fillers or materials may be provided. For example, one or more of the above materials may include carbon fibers (e.g., carbon fiber reinforced PEEK) and / or polymer materials, or some or all of the above materials. The polymer material may include a composite material or a woven material, for example, a polymer material that includes or is woven with fibers such as carbon fibers, steel fibers, basalt fibers, or the like. Carbon, carbon fibers, steel fibers, or other fibers (e.g., basalt fibers) may account for 5%, 10%, 20%, 30%, 40%, or 50% of the reinforcing material by weight or by volume. The fibers may include the same or different materials as the polymer containing the fibers.

[0040] Now refer to Figure 2 , for systems utilizing larger tubing (e.g., tubing having an outer diameter of 1 / 8"), a perspective view of an assembled fluid connection system 1 is shown. The fluid connection system 1 includes a tubing 2 on which a threaded fastener 4 is positioned. The system 1 includes a fitting assembly 6. The fitting assembly 6 includes a ferrule 8 and a locking ring 10. The system is assembled by sliding the threaded fastener 4 onto the tubing 2 through an internal bore of the threaded fastener, then positioning the locking ring 10 (through an internal bore in the locking ring) onto the tubing 2, and then pressurizing the ferrule 8 (through an internal bore in the ferrule) onto the end of the tubing 2 within an opening in the locking ring 10 to create a locking ring. Figure 2 The fluid connection system shown in 1. Figure 3 An exploded view of a fluid connection system 1 is provided in FIG. 1 , which shows a pipe 2, a threaded fastener 4, a locking ring 10, and a ferrule 8. Figure 3As shown, the locking ring 10 includes a tapered feature 12 on a first side that serves as a centering feature for centering the fitting assembly 6 within the threaded fastener 4 . Figure 4 A perspective view of the locking ring 10 having the tapered feature 12 is shown. Figure 5 A cross-sectional view of the locking ring 10 is provided in FIG. 1 , which further depicts the tapered feature 12 and also depicts the inner diameter D defining the locking ring 10 . I The inner diameter of the locking ring 10 at the first end or portion of the inner bore has a first diameter D1. Figure 5 As shown, the inner diameter of the locking ring 10 at the second end or portion of the locking ring 10 opposite the end defined by the tapered feature 12 has a second diameter D2. Diameter D2 is greater than diameter D1, in other words, the inner diameter of the locking ring 10 is greater at the end or portion of the locking ring 10 opposite the tapered feature 12. The second end or portion of the internal bore of the locking ring 10 having the larger inner diameter D2 defines a flared opening 13. The end of the locking ring 10 having the flared opening 13 is sized and shaped to receive the ferrule 8. The flared opening 13 is larger at the outer edge of the opening to allow the user to more easily guide the ferrule 8 into the internal bore. Although the tapered portion 12 is shown as being frustoconical in shape and the flared portion of the bore is shown as being curved, it should be noted that the tapered portion 12 may be curved and may extend at various angles from a plane perpendicular to the longitudinal axis of the locking ring 10, such as between 60 and 80 degrees, between 45 and 85 degrees, and between 30 and 85 degrees.

[0041] exist Figure 6 A perspective view of the ferrule 8 is provided in FIG. Figure 6 As shown, the collar 8 is generally cylindrical in shape with an internal bore of the collar, and the collar 8 can be symmetrical on a plane perpendicular to its longitudinal axis (the longitudinal axis can be the same longitudinal axis as the longitudinal axis of the system), so that the collar 8 can be installed on the pipe 2 facing in either direction, so as to improve the speed and ease of assembly and reduce errors during the assembly process.

[0042] Figure 7 A cut-away side view of the assembled fluid connection system 1 is shown. To properly center the fitting assembly 6 within the threaded fastener 4, the threaded fastener 4 includes a tapered feature 14 at the edge of the fitting pocket 16. The tapered feature 14 is sized and shaped to abut with the tapered feature 12 of the locking ring. These abutting tapered features are designed to slide where they abut so that the fitting assembly 6 and the pipe 2 are not twisted when the fitting assembly 6 is torqued into the mating port. Thus, as shown in FIG. Figure 7As shown, the tapered feature 14 of the threaded fastener 4 receives the tapered feature 12 of the fitting assembly 6 for properly centering the fitting assembly 6 within the threaded fastener 4. The opening in the threaded fastener 4 is large enough to accommodate even the largest of applicable pipes.

[0043] Figure 8 A cross-sectional side view of the fluid connection system 1 coupled to the threaded port 18 is shown. Figure 8 As shown, the size and shape of the tapered feature 14 of the threaded fastener 4 is set in conjunction with the height of the fitting assembly 6 so that the fitting assembly 6 protrudes an optimal amount from the tip of the threaded fastener 4. A protrusion of the fitting assembly 6 that is too small will result in sealing difficulties due to the limitation of forming threads until the bottom of the port. However, a protrusion of the fitting assembly 6 that is too large will not be suitable for shallow ports due to the limited thread engagement. Therefore, the universal system disclosed herein allows for use in larger diameter piping systems and smaller diameter piping systems in both deep threaded ports and shallow threaded ports.

[0044] According to an embodiment of the present disclosure, the collar 8 and the locking ring 10 can each include a biocompatible polymer, such as polyetheretherketone (PEEK). Other polymer materials that can be used for one or more of the collar 8 or the locking ring 10 include, but are not limited to, Perfluoroalkoxy (PFA, also known as perfluoroalkylethylene), polytetrafluoroethylene (PTFE), ETFE (polymer of tetrafluoroethylene and ethylene), polyetherimide (PEI), polyphenylene sulfide (PPS), polypropylene, sulfone polymers, polyolefins, polyimides, other polyaryletherketones, other fluoropolymers, polyoxymethylene (POM), polyaryletherketone (PAEK), polyetherketone (PEKK), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA, also known as perfluoroalkylethylene) or polychlorotrifluoroethylene (PCTFE). In addition, PEEK (or other polymers) reinforced or woven with carbon, carbon fiber, steel fiber or the like can be used. For example, in some embodiments, the locking ring 10 can include a reinforced PEEK polymer to increase the stiffness of the locking ring. In addition, in some embodiments, one or more components of the accessory assembly 6 can be coated with a material to increase strength, improve chemical resistance, improve temperature stability or reduce permeability. Such coatings include, but are not limited to, metallization, polymer coatings, silicon-based coatings, and carbon-based coatings. Additionally, in some embodiments, one or more components of the fitting assembly 6 may be heat treated to improve properties such as crystallinity, chemical resistance, or permeability. In certain embodiments, the ferrule 8 may include an unfilled PEEK polymer and may be produced by injection molding or extruding a tube and then cutting the tube into the desired final length to form the ferrule 8.

[0045] Now refer to Fig. 9 , another embodiment of a fluid connection system 20 according to aspects of the present disclosure is provided. The fluid connection system 20 may include the same Figures 2 to 8 The system 20 is a threaded fastener 4 that is identical to the threaded fastener described above, and a pipe 22 and a fitting assembly 24. The threaded fastener 4 is secured to the pipe 22 via the fitting assembly 24. The pipe 22 may have an outer diameter of 1 / 16". The fitting assembly 24 includes a ferrule 26 and a locking ring 28. Assembly of the system 20 is accomplished by sliding the threaded fastener 4 onto the pipe 22, then positioning the locking ring 28 onto the pipe 22, and then pressurizing the ferrule 26 onto the end of the pipe 22 within the opening of the locking ring 28 to create a locking ring. Fig. 9 The fluid connection system 20 is shown. Fig.10 , which depicts a pipe 22, a threaded fastener 4, a locking ring 28, and a ferrule 26. Depending on the intended application (e.g., pressure, temperature, solvents used, etc.), the same or different materials may be used for the fastener 4 and / or the pipe 2.

[0046] like Fig.10 As shown, the locking ring 28 is generally cylindrical in shape and is symmetrical so that the locking ring 28 can be positioned on the pipe 22 in either orientation, allowing for easier and faster assembly with less tolerance. Fig.11 A perspective view of the locking ring 28 is shown. Fig.11 As shown, the locking ring 28 is symmetrical so that the locking ring 28 can be assembled on the pipe 22 in either direction, thereby assembling more easily and quickly with less error. In other words, the inner diameter of the locking ring 28 (eg Fig.12 D I The locking ring 28 is shown as being constant in a central region and has symmetrical flared portions at each end region of the locking ring 28 . Fig.12 2 shows a cross-sectional side view of the locking ring 28 taken about the longitudinal axis of the locking ring 28. Fig.12 As shown, the inner diameter D of the locking ring 28 is I is larger at the ends, wherein the inner diameter D of the locking ring 28 in the central region is I is constant, so that the locking ring 28 is symmetrical, so that the locking ring 28 can be assembled to the pipe 22 in either direction while having the same clamping effect. Fig.13 The ferrule 26 shown in the perspective view in FIG. 1 is also symmetrical so that the ferrule 26 can be assembled to the pipe 22 in either orientation with the same result. By allowing one or both of the locking ring 28 and the ferrule 26 to be assembled to the pipe 22 in either orientation, assembly time and errors introduced during assembly of the fluid connection system 20 are reduced.

[0047] Fig.14 A cut-away side view of an assembled fluid connection system 20 is shown. The fitting pocket 16 of the threaded fastener 4 is sized and shaped to receive an assembled fitting assembly 24 that includes a ferrule 26 and a locking ring 28. The fitting pocket 16 helps center the assembled fitting assembly 24 by abutting the walls defining the fitting pocket 16 with the outer surface of the locking ring 28 and by preventing the locking ring 28 from extending beyond an end wall 29 defining the fitting pocket 16.

[0048] Fig.15 A cross-sectional side view of the fluid connection system 20 coupled to the threaded port 30 is shown. Fig.15 As shown, the size and shape of the mating recess 16 of the threaded fastener 4 is set in conjunction with the height of the fitting component 24 so that the collar 26 protrudes an optimal amount from the tip of the fitting component 24. Too little protrusion from the tip of the fitting component 24 will result in sealing difficulties due to the limitation of forming threads until the bottom of the port, but too much protrusion from the tip of the fitting component 24 will not be suitable for shallow ports due to the limited thread engagement. Therefore, the universal system disclosed herein allows for use in larger diameter piping systems and smaller diameter piping systems in both deep threaded ports and shallow threaded ports. In addition, the opening in the threaded fastener 4 is large enough to accommodate even the largest of applicable pipes, as shown in reference Figures 2 to 8 Such an exemplary embodiment of a fluid connection system according to aspects of the present disclosure is shown and described. In addition, the interface between the ferrule 26 and the locking ring 28 is optimized to reduce installation forces and material creep while maintaining a metal-free system.

[0049] According to an embodiment of the present disclosure, the ferrule 26 and the locking ring 28 of the fitting assembly 24 may each include a biocompatible polymer, such as polyetheretherketone (PEEK). Other polymer materials that may be used for one or more of the ferrule 26 or the locking ring 28 include, but are not limited to, Perfluoroalkoxy (PFA, also known as perfluoroalkylethylene), polytetrafluoroethylene (PTFE), ETFE (polymer of tetrafluoroethylene and ethylene), polyetherimide (PEI), polyphenylene sulfide (PPS), polypropylene, sulfone polymers, polyolefins, polyimides, other polyaryletherketones, other fluoropolymers, polyoxymethylene (POM), polyaryletherketone (PAEK), polyetherketone (PEKK), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA, also known as perfluoroalkylethylene) or polychlorotrifluoroethylene (PCTFE) and others. In addition, PEEK (or other polymers) reinforced or braided with carbon, carbon fiber, steel fiber or the like can be used. For example, in some embodiments, the locking ring 10 can include a reinforced PEEK polymer to increase the stiffness of the locking ring. In addition, in some embodiments, one or more components of the accessory assembly 24 can be coated with a material to increase strength, improve chemical resistance, improve temperature stability or reduce permeability. Such coatings include, but are not limited to, metallization, polymer coatings, silicon-based coatings, and carbon-based coatings. Additionally, in some embodiments, one or more components of the fitting assembly 24 may be heat treated to improve properties such as crystallinity, chemical resistance, or permeability. In certain embodiments, the ferrule 8 may include an unfilled PEEK polymer and may be produced by injection molding or extruding the tube and then cutting the tube into the desired final length. Depending on the intended application (e.g., pressure, temperature, solvent used, etc.), the same or different materials may be used for the fastener 4 and / or the pipe 22.

[0050] It will be appreciated that, as described below, the tubing and fitting assemblies or components of the connection systems used in many analytical instrument systems for fluid connections can be very small. In addition, the components used in many analytical instrument systems can vary and often need to be changed or replaced, for example, replacing tubing columns, pumps, injection valves, etc., whether when switching from one specific application of a system for one type of analysis to another specific application or when substantially reorganizing the system and its components. In view of the smaller size of tubing and fitting assemblies or fluid connection components (e.g., nuts, ferrules, sleeves, transfer tubing, tips, etc.), especially together with the complexity of many analytical instrument systems, sometimes in very awkward or difficult-to-reach locations with many connections in a small space, many operators often spend extra time and effort to position tubing for connection or to position fitting assemblies.

[0051] Thus, the present disclosure provides a threaded fastener and fitting assembly that can be used to form one or more connections in any system that utilizes a face seal (e.g., a flat bottom port) and can withstand the fluid pressures required for instrument applications. It will be noted that the fitting and tubing assembly configurations described and illustrated in the present disclosure are focused on only one end of the tubing and fitting assembly, but the present disclosure can be used in embodiments as a complete fluid connection between two components for providing a fluid connection between any two points in an analytical instrumentation system or other system.

[0052] The pipe and fitting assembly shown and disclosed herein will successfully handle the fluid connection in the system where the fluid volume under low pressure is needed.For example, the pipe according to the present disclosure can have an outer diameter (OD) in the range from about 1 / 64 inch to about 1 / 4 inch or include a diameter of about 1 / 64, 1 / 32, 1 / 16, 1 / 8 or 1 / 4 inch, and can have an internal diameter from about 0.001 inch to about 0.096 inch or include an internal diameter of about 0.001, 0.002, 0.006, 0.010, 0.015, 0.020, 0.025, 0.030, 0.060, 0.085 or .095 inch.In addition, the assembly shown and described in the present disclosure can withstand a pressure of up to about 500PSI under a finger tightening torque value of, for example, 1 inch*pound.These assemblies are also flexible and can be connected multiple times before failure. It is believed that the fitting assembly of the present disclosure is able to convert rotational torque directly into axial force to create a seal with a flat bottom port. Using such torque loads to form a test connection with a fitting assembly according to the present disclosure, we were able to obtain a sealed fluid connection that maintained a seal at fluid pressures up to 500 psi before bursting or leaking.

[0053] Although the present invention has been shown and described in various embodiments, those skilled in the art will understand from the drawings and the foregoing discussion that various changes, modifications and variations may be made without departing from the spirit and scope of the present invention as set forth in the claims. For example, the shape, size, features and materials of the accessory components, fluid connections and / or analytical instrument systems of the present disclosure may be changed. Therefore, the embodiments shown and described in the drawings and the foregoing discussion are merely illustrative and do not limit the scope of the present invention as defined in the claims herein. The embodiments and specific forms, materials and the like are merely illustrative and do not limit the scope of the present invention or the claims herein.

Claims

1. A fluid connection system, comprising: A locking ring having a first inner diameter at the first end and the second end, wherein a second inner diameter in a central region of the locking ring is smaller than the first inner diameter; ferrule, the size and shape of the ferrule are set to be positioned within the first inner diameter of the locking ring; and A threaded fastener having a passage sized and shaped to removably receive a tube therein, the threaded fastener also having (i) an internal tapered portion at a first end of the threaded fastener and (ii) a seating portion sized and shaped to removably receive the locking ring within the threaded fastener.

2. The fluid connection system according to claim 1, wherein: The locking ring and the ferrule are each symmetrical in a plane perpendicular to its longitudinal axis, such that the locking ring and the ferrule can each be positioned on the pipe in either direction.

3. The fluid connection system according to claim 1, wherein: The locking ring and the ferrule each include a biocompatible material.

4. The fluid connection system according to claim 1, wherein: The tubing has an outer diameter of 1 / 16".

5. The fluid connection system according to claim 1, wherein: At least one of the locking ring and the ferrule comprises at least one of polyetheretherketone (PEEK), polyaryletherketone (PAEK), polyetherketoneketone (PEKK), fluorinated ethylene propylene (FEP), ethylenetetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA, also known as perfluoroalkylethylene), or polychlorotrifluoroethylene (PCTFE).

6. The fluid connection system according to claim 5, wherein: The locking ring comprises PEEK.

7. The fluid connection system according to claim 6, wherein: The locking ring comprises reinforced PEEK.

8. The fluid connection system according to claim 1, wherein: Each of the locking ring and the ferrule has an end that defines a surface which is sealable against the bottom of the flat bottom port.

9. The fluid connection system according to claim 8, wherein: The seal is sufficient to withstand fluid pressures between 0 and 200 psi.

10. The fluid connection system according to claim 1, wherein: When assembled, a portion of the first end of the locking ring and the end of the ferrule extend beyond the first end of the threaded fastener.

11. A biocompatible fluid connection system, which includes: a locking ring having (i) a first inner diameter at the first end, (ii) a second inner diameter at the second end which is smaller than the first inner diameter, and (iii) a tapered portion at the second end; ferrule, the size and shape of the ferrule are set to be positioned within the first inner diameter of the locking ring; and A threaded fastener having a passage sized and shaped to removably receive a tube therein, the threaded fastener also having a tapered portion at a first end of the threaded fastener sized and shaped to mate with the tapered portion of the locking ring.

12. The fluid connection system according to claim 11, wherein: The ferrule is symmetrical with respect to the longitudinal axis so that the ferrule can be positioned on the pipe in either direction.

13. The fluid connection system according to claim 11, wherein: The locking ring and the ferrule each include a biocompatible material.

14. The fluid connection system according to claim 11, wherein: The tubing has an outer diameter of 1 / 8".

15. The fluid connection system of claim 11, wherein At least one of the locking ring and the ferrule comprises at least one of PEEK, PAEK, PEKK, FEP, ETFE, PTFE, PFA or PCTFE.

16. The fluid connection system of claim 15, wherein The locking ring comprises PEEK.

17. The fluid connection system according to claim 16, wherein: The locking ring comprises reinforced PEEK.

18. The fluid connection system according to claim 11, wherein: Each of the locking ring and the ferrule has an end that is a substantially flat face capable of providing a seal when pressed against the bottom of a flat bottom port.

19. The fluid connection system of claim 18, wherein The seal is sufficient to withstand fluid pressures between 0 and 200 psi.

20. The fluid connection system of claim 11, wherein: When assembled, a portion of the first end of the locking ring and an end of the ferrule extend beyond the first end of the threaded fastener.

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