System and method for sterile urine sampling - Patents.com

Abstract

A urine sampling system for sterile urine sampling includes a catheter assembly and a sampling port access device. The catheter assembly includes a urinary catheter, a drainage tube, and a connector that fluidly connects the urinary catheter to the drainage tube and includes a urine sampling port. The sampling port access device includes a tip at the end of a barrel configured to fluidly connect the sampling port access device to the urine sampling port of the catheter assembly. The tip of the sampling port access device and the urine sampling port each have complementary fastening means for fastening to the other of the tip of the sampling port access device and the urine sampling port, respectively. The complementary fastening means ensure proper mating of the tip of the sampling port access device and the urine sampling port for sterile urine sampling.

Description

[Technical field]

[0001] The present invention relates to a system and method for sterile urine sampling. [Background technology]

[0002] Hospitals across the nation are understandably focusing on catheter-associated urinary tract infection (CAUTI) prevention bundles to achieve better outcomes, limit the risk of Centers for Medicare and Medicaid Services (CMS) reimbursement penalties, and reduce the incidence of antimicrobial resistance. Historically, prevention efforts have focused on closed systems, sterile insertion technique, and maintenance of patients with Foley catheters. However, to date, little focus has been placed on the large variability associated with urine sampling practices, despite 96% of nursing decision makers believing there is variability in how nurses within their facilities collect urine samples from Foley catheters. Summary of the Invention [Problem to be solved by the invention]

[0003] Studies suggest that variability exists in all aspects of urine sampling, including where the urine sample is taken from the collection system, how the urine sampling area is cleaned, the device used to collect the urine sample, and how the urine sample is transported to the laboratory. This variability is a fundamental issue that impacts the documentation of CAUTI results. In fact, 100% of nursing decision makers believe that variability and improper urine sampling technique increase the risk of contamination, which may result in a false-positive CAUTI. Furthermore, up to 70% of urine cultures reflect false-positive results that not only lead to inaccurate CAUTI diagnoses and inappropriate antibiotic treatment, but also artificially undermine the time and resources hospitals are spending to reduce the risk of CAUTI by other means. This issue presents an ongoing challenge to those seeking to reduce CAUTI rates to avoid CMS reimbursement penalties.

[0004] Disclosed herein is a urine sampling system and method that addresses at least the foregoing. [Means for solving the problem]

[0005] In some embodiments, a urine sampling system for sterile urine sampling is disclosed that includes a catheter assembly and a sampling port access device. The catheter assembly includes a urinary catheter, a drainage tube, and a connector that fluidly connects the urinary catheter to the drainage tube. The connector includes a urine sampling port. The sampling port access device includes a tip at the end of a barrel configured to fluidly connect the sampling port access device to the urine sampling port of the catheter assembly. The tip of the sampling port access device and the urine sampling port each have complementary fastening means for fastening to the other of the tip of the sampling port access device and the urine sampling port, respectively. The complementary fastening means ensure proper mating of the tip of the sampling port access device and the urine sampling port for sterile urine sampling.

[0006] In some embodiments, the complementary securing means on the tip of the sampling port access device comprises complementary threads configured such that the female threads of a locking ring or rotatable locking collar around the male connector on the tip of the sampling port access device mate with the male threads around the female connector of the urine sampling port.

[0007] In some embodiments, the complementary fixing means on the tip of the sampling port access device comprises complementary threads configured such that the male threads around the male connector on the tip of the sampling port access device mate with the female threads on the female connector of the urine sampling port.

[0008] In some embodiments, the screw may include two or more Thread Two or more thread patterns are included. Thread At least the first of Thread is two or more Thread The second of Thread Greater than Thread It has a diameter.

[0009] In some embodiments, the screw has three Thread The screw pattern includes a thread pattern having In some embodiments, the threads include a left-handed thread pattern. In some embodiments, the tip of the sampling port access device and the urine sampling port match the color of the other of the sampling port access device tip and the urine sampling port, respectively. When the colors of the sampling port access device tip and the urine sampling port match, the risk of urine sample contamination due to an incorrect attempt to connect the sampling port access device tip or the urine sampling port is reduced.

[0010] In some embodiments, the urine sampling system further includes one or more septum-stopped test tubes, wherein the internal pressure of each of the one or more test tubes is less than atmospheric pressure, and each of the one or more test tubes is also independently configured to include a urinalysis formulation, a microbiological analysis formulation, or to be free of additives or preservatives.

[0011] In some embodiments, each of the one or more test tubes has an outer diameter that matches or is smaller than the inner diameter of the barrel of the sampling port access device such that each of the one or more test tubes can be slid into the barrel such that a needle of the sampling port access device can pierce a septum stopper of the test tube for urine sampling.

[0012] In some embodiments, a catheter assembly is also disclosed that includes a urinary catheter, a drainage tube, and a connector that fluidly connects the urinary catheter to the drainage tube. The connector has a left-handed thread pattern, a first Thread The second Thread Greater than Thread Thread pattern with diameters greater than two Thread or more than two Thread The urine sampling port includes a urine sampling port having threads of either a left-handed thread pattern having ...

[0013] In some embodiments, the threads include male threads around the female connector of the urine sampling port. In some embodiments, the threads include the female threads of a female connector of a urine sampling port.

[0014] In some embodiments, the screw has three Thread The screw pattern includes a thread pattern having In some embodiments, the threads include a left-handed thread pattern. In some embodiments, a sampling port access device is also disclosed that includes a barrel, a hollow needle including a tip, and a tip at the end of the barrel. The needle is coaxially disposed within the barrel such that the tip of the needle is protected by the barrel. The tip at the end of the barrel is fluidly connected to the needle. The tip at the end of the barrel includes a left-handed thread pattern, a first thread, a second thread, a third thread, a fourth thread, a fifth thread, a fifth thread, a fifth thread, a sixth thread, a fifth thread, a sixth thread, a fifth thread, a sixth thread, a fifth thread, a sixth thread, a sixth thread, a fifth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a sixth thread, a seventh ... Thread The second Thread Greater than Thread Thread pattern with diameters greater than two Thread or more than two Thread The sampling port access device has either a left-handed thread pattern having a tip at the end of the barrel configured to mate with complementary threads on a sampling port of another device. The complementary threads ensure proper mating of the sampling port access device and the sampling port of another device for sterile sampling.

[0015] In some embodiments, the threads comprise female threads in a locking ring or collar around the male connector at the tip of the sampling port access device. In some embodiments, the locking ring is either non-rotatably attached to or molded with the barrel. The sampling port access device is configured to mate with the sampling port of another device by threading the entire sampling port access device into the sampling port of the other device.

[0016] In some embodiments, the locking collar is rotatably attached to the barrel and the sampling port access device is configured to mate with a sampling port of another device by threading the locking collar of the sampling port access device into the sampling port of the other device while holding the barrel stationary.

[0017] In some embodiments, the threads include male threads around a male connector at the tip of the sampling port access device. In some embodiments, the screw has three Thread The left-hand thread pattern includes [Brief description of the drawings]

[0018] [Figure 1] 1 provides a schematic diagram illustrating a urine sampling system featuring complementary fastening means for a urine sampling port of a catheter assembly and a sampling port access device, according to some embodiments. [Figure 2A] 1 provides a schematic diagram illustrating the female threads of a locking ring or locking collar around a male connector of a sampling port access device configured to mate with the male threads around a female connector of a urine sampling port, according to some embodiments. [Figure 2B]1 provides a schematic diagram showing male threads around a male connector at the tip of a sampling port access device configured to mate with female threads of a female connector of a urine sampling port, according to some embodiments. [Figure 3A] 1 provides a schematic diagram illustrating a thread including a right-handed thread pattern, according to some embodiments. [Figure 3B] 1 provides a schematic diagram illustrating a thread including a left-handed thread pattern, according to some embodiments. [Figure 4A] FIG. 1 provides a schematic diagram illustrating a screw including a thread pattern having one thread, according to some embodiments. [Figure 4B] FIG. 1 provides a schematic diagram illustrating a screw including a first thread pattern having two threads, according to some embodiments. [Figure 4C] FIG. 1 provides a schematic diagram illustrating a cross-section of a first thread pattern having two threads, according to some embodiments. [Figure 4D] FIG. 1 provides a schematic diagram illustrating a screw including a second thread pattern having two threads, according to some embodiments. [Figure 4E] FIG. 1 provides a schematic diagram illustrating a cross-section of a second thread pattern having two threads, according to some embodiments. [Figure 4F] FIG. 1 provides a schematic diagram illustrating a screw including a thread pattern having three threads, according to some embodiments. [Figure 5A] FIG. 1 provides a schematic diagram illustrating a first thread form, according to some embodiments. [Figure 5B] 1 provides a schematic diagram illustrating a second thread form, according to some embodiments. [Figure 5C] FIG. 1 provides a schematic diagram illustrating a third thread form, according to some embodiments. [Figure 5D] FIG. 1 provides a schematic diagram illustrating a fourth thread form, according to some embodiments. [Figure 5E] FIG. 1 provides a schematic diagram illustrating a fifth thread form, according to some embodiments. [Figure 5F]FIG. 1 provides a schematic diagram illustrating a sixth thread form, according to some embodiments. [Figure 5G] FIG. 13 provides a schematic diagram illustrating a seventh thread form, according to some embodiments. [Figure 5H] FIG. 13 provides a schematic diagram illustrating an eighth thread form, according to some embodiments. [Figure 5I] FIG. 13 provides a schematic diagram illustrating a ninth thread form, according to some embodiments. [Figure 5J] FIG. 13 provides a schematic diagram illustrating a tenth thread form, according to some embodiments. [Figure 5K] FIG. 13 provides a schematic diagram illustrating an eleventh thread form, according to some embodiments. [Figure 5L] FIG. 13 provides a schematic diagram illustrating a twelfth thread form, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for the features of any of the other embodiments disclosed herein.

[0020] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "front", "rear", "top", "bottom", "forward", "reverse", "clockwise", "counterclockwise", "upper", "lower", or other similar terms such as "upper", "lower", "rear", "front", "vertical", "horizontal", "proximal", "distal" are used for convenience and are not intended to imply a particular fixed position, orientation, or direction, for example. Instead, such labels are used to reflect, for example, a relative position, orientation, or direction. Singular forms such as "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0021] For example, with respect to the "proximal," "proximal portion," or "proximal end" of a catheter disclosed herein, includes the portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests the contrary, the proximal portion, proximal end, or proximal length of a catheter is not equivalent to the length of the distal portion or distal end of the catheter.

[0022] For example, with respect to the "distal," "distal portion," or "distal end" of a catheter disclosed herein, includes the portion of the catheter that is intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within a patient when the catheter is used with the patient. The distal portion, end, or length of a catheter can include the distal end of the catheter. However, the distal portion, end, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests the contrary, the distal portion, end, or length of a catheter is not equivalent to the length of the terminal portion or end of the catheter.

[0023] 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. When a patient with a urinary catheter requires a urine sample, the urine sample is collected by one of several different methods using one of a variety of different products for collecting urine samples. Typically, urine samples are collected using a "clean" procedure, which is not sterile and therefore cannot avoid contamination of the urine sample. It has been determined that variability in urine sampling, such as where the urine sample is taken from the collection system, how the urine sampling area is cleaned, the device used to collect the urine sample, and how the urine sample is transported to the laboratory, can increase the risk of false positive urine cultures. This can later lead to an incorrect CAUTI diagnosis and inappropriate antibiotic treatment. Thus, variability in urine sampling is a fundamental issue that presents a continuing challenge to those seeking to lower CAUTI rates to avoid CMS reimbursement penalties. Additionally, Centers for Disease Control (CDC) guidelines state that urine sampling from urinary catheters must be performed using aseptic technique.

[0024] Disclosed herein is a urine sampling system and method that addresses at least the foregoing. The urine sampling system described herein may be included in a urine sampling kit, as disclosed in U.S. Provisional Application No. 62 / 675,112, filed May 22, 2018, entitled "Urine Sampling Kit and Method Thereof," which is incorporated herein by reference in its entirety.

[0025] Urine Sampling System FIG. 1 provides a schematic diagram illustrating a urine sampling system 100 featuring complementary fastening means for a urine sampling port 142 of a catheter assembly 110 and a sampling port access device 150, according to some embodiments.

[0026] As shown, the urine sampling system 100 includes a catheter assembly 110 and a sampling port access device 150. The catheter assembly 110 includes a urinary catheter 120, a drainage tube 132, and a connector 140 that fluidly connects the urinary catheter 120 to the drainage tube 132. The connector 140 includes a urine sampling port 142, which is shown in general form in view of its various embodiments. The sampling port access device 150 includes a barrel 152, a hollow needle 154 including a tip 155, and a tip 156 at the end of the barrel 152, which is shown in general form in view of its various embodiments. The needle 154 is coaxially disposed within the barrel 152 such that the tip 155 of the needle 154 is protected by the barrel 152. The tip 156 at the end of the barrel 152 is fluidly connected to the needle 154. The tip 156 of the sampling port access device 150 and the urine sampling port 142 each have complementary fastening means for fastening to or exclusively connecting to the other of the tip 156 of the sampling port access device 150 and the urine sampling port 142. The complementary fastening means ensure proper mating of the tip 156 of the sampling port access device 150 and the urine sampling port 142, respectively, for sterile urine sampling.

[0027] The tip 156 of the sampling port access device 150 and the urine sampling port 142 may match the color of the other of the tip 156 of the sampling port access device 150 and the urine sampling port 142, respectively. Such colors may be exclusive to the urine sampling system 100. When the tip 156 of the sampling port access device 150 and the urine sampling port 142 match in color, especially when the color is exclusive to the urine sampling system 100, the risk of urine sample contamination due to an erroneous connection attempt, such as connecting the tip 156 of the sampling port access device 150 or the urine sampling port 142 to another component that includes a fastening means that is part of a Luer lock fastening system, is reduced.

[0028] Although not shown in FIG. 1, the urine sampling system 100 further includes one or more septum-stopped test tubes according to some embodiments. Each of the one or more test tubes has an outer diameter that is approximately matched to or somewhat smaller than the inner diameter of the barrel 152 of the sampling port access device 150. With such dimensions, the test tube can be slid into the barrel 152 and the needle 154 of the sampling port access device 150 can pierce the septum stopper of the test tube for urine sampling. The internal pressure of each of the one or more test tubes is evacuated to below atmospheric pressure. If urine is present in the connector 140, the evacuated test tube is inserted into the barrel 152 of the sampling port access device 150, the septum stopper of the test tube is pierced with the needle 154 disposed in the barrel 152, and urine is drawn into the test tube through the needle 154, which is hollow to provide a fluid conduit between the connector 140 and the test tube. Each of the one or more test tubes may also be independently configured to contain a formulation for urinalysis, a formulation for microbiological analysis, or to be free of additives or preservatives, such formulations allowing the urine sample to be stored for several hours without refrigeration.

[0029] Fastening system Complementary fastening means form a fastening system. A fastening means is a complementary fastening means if, during assembly of two parts containing the complementary fastening means, or at least during partial assembly of two parts containing the complementary fastening means, it complements another fastening means for assembling two parts each containing one of the complementary fastening means. For example, a fastening means of either the urine sampling port 142 of the connector 140 or the tip 156 of the sampling port access device 150 is a complementary fastening means of the other for assembling the connector 140 and the sampling port access device 150 for sterile urine sampling.

[0030] Fastening means include, but are not limited to, the threads of a threaded part. A thread is complementary (e.g., complementary male) if, during assembly of two parts containing complementary threads, or at least during partial assembly of two parts containing complementary threads, the threads complement another thread (e.g., complementary female thread) for assembling two parts each containing one of the complementary threads. For example, the threads of either the urine sampling port 142 of the connector 140 or the tip 156 of the sampling port access device 150 are complementary to the other for assembling the connector 140 and the sampling port access device 150 for sterile urine sampling.

[0031] The fastening means is not part of the Luer lock fastening system, which is the standard fastening system in the medical industry as defined in ISO80369-7:2016. Thus, the fastening means does not include any of the complementary threads found on a pair of parts configured to connect via a Luer lock fastening system. In fact, the fastening means of the fastening system disclosed herein is purposely distinct from that of a Luer lock fastening system. This allows for improved mechanical integrity in the instant fastening system over a Luer lock fastening system, which at least reduces precession or "wobble" when assembling any two parts that include complementary fastening means of the fastening system over a Luer lock fastening system. The enhanced mechanical integrity is expected to reduce fumbling by clinicians when using the fastening system, thereby reducing contamination-inducing behavior. Fluid seal integrity is also expected to be enhanced in the instant fastening system over a Luer lock fastening system, which is further expected to reduce contamination-inducing behavior when using the fastening system by clinicians.

[0032] FIG. 2A provides a schematic diagram of the female threads 257A of a locking ring 258A or locking collar 258B around the male connector 259 of the tip 156 of the sampling port access device 150, configured to mate with the male threads 244A around the female connector 246 of the urine sampling port 142, in accordance with some embodiments.

[0033] As thus shown, the complementary fastening means of the tip 156 of the sampling port access device 150, in some embodiments, comprises complementary threads configured such that the internal threads 257A of the locking ring 258A or locking collar 258B around the male connector 259 mate with the external threads 244A around the female connector 246 of the urine sampling port 142. Thus, the complementary fastening means of the urine sampling port 142, in corresponding embodiments, comprises complementary threads configured such that the external threads 244A around the female connector 246 of the urine sampling port 142 mate with the internal threads 257A of the locking ring 258A or locking collar 258B around the male connector 259 of the sampling port access device 150. The complementary fastening means ensure proper mating of the tip 156 of the sampling port access device 150 and the urine sampling port 142, respectively, for sterile urine sampling.

[0034] With regard to the locking ring 258A, the locking ring 258A is either fixedly and non-rotatably attached to the barrel 152 of the sampling port access device 150 or is molded with the barrel 152 in a so-called one-piece design. When configured with such a locking ring 258A, the sampling port access device 150 is configured to mate with a sampling port of another device (e.g., the urine sampling port 142 of the connector 140) by threading the entire sampling port access device 150 into the sampling port of the other device.

[0035] With regard to the locking collar 258B, the locking collar 258B is rotatably attached to the barrel 152 of the sampling port access device 150 in a so-called two-piece design. The sampling port access device 150 is configured to mate with a sampling port of another device (e.g., the urine sampling port 142 of the connector 140) by threading the locking collar 258B of the sampling port access device 150 into the sampling port of the other device while holding the barrel 152 of the sampling port access device 150 stationary.

[0036] FIG. 2B provides a schematic diagram showing male threads 257B around the male connector 259 of the tip 156 of the sampling port access device 150 configured to mate with female threads 244B of the female connector 246 of the urine sampling port 142, according to some embodiments.

[0037] As thus shown, the complementary fastening means of the tip 156 of the sampling port access device 150, in some embodiments, comprises complementary threads, such that the male threads 257B around the male connector 259 are configured to mate with the female threads 244B of the female connector 246 of the urine sampling port 142. Thus, the complementary fastening means of the urine sampling port 142, in a corresponding embodiment, comprises complementary threads, such that the female threads 244B of the female connector 246 of the urine sampling port 142 are configured to mate with the male threads 257B around the male connector 259 of the sampling port access device 150. Again, the complementary fastening means ensure proper mating of the tip 156 of the sampling port access device 150 and the urine sampling port 142, respectively, for sterile urine sampling.

[0038] 2A and 2B, the male connector 259 of the tip 156 of the sampling port access device 150 and the female connector 246 of the urine sampling port 142 are each configured with a size and shape to ensure proper mating of the tip 156 of the sampling port access device 150 and the urine sampling port 142 for sterile urine sampling. The male connector 259 and the female connector 246 can each be sized with a length and depth to allow sufficient engagement of an end of the male connector 259 with a valve 248 (e.g., a split septum valve) disposed within the urine sampling port 142 of the connector 140. The male connector 259 and the female connector 246 can each be shaped to create a fluid-tight seal between the male connector 259 and the female connector 246 when the male connector 259 is fully engaged with the valve 248 of the urine sampling port 142 of the connector 140.

[0039] With respect to the shape of the male connector 259 of the tip 156 of the sampling port access device 150 and the female connector 246 of the urine sampling port 142, the male connector 259 and the female connector 246, respectively, can be molded to match or not match the other of the male connector 259 and the female connector 246. In some cases, where a first material (e.g., a harder material) is used for the male connector 259 and a second, different material (e.g., a softer material) is used for the female connector 246, it is desirable to create a slight mismatch, such as the male connector 259 having a greater taper than the female connector 246. Thus, the male connector 259 and the female connector 246 can each be independently tapered or non-tapered. In some embodiments, if the male connector 259 or the female connector 246 is tapered, the taper is at least 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10% taper. In some embodiments, if the male connector 259 or the female connector 246 is tapered, the taper is no more than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%. Thus, in some embodiments, if the male connector 259 or the female connector 246 is tapered, the taper is no more than 1% and no more than 10%, including a taper of at least 4% and no more than 8%, such as a taper of at least 3% and no more than 9%, such as a taper of at least 5% and no more than 7%.

[0040] The urine sampling port 142 of the connector 140 of the catheter assembly 110 and the tip 156 at the end of the barrel 152 of the sampling port access device 150, respectively, are shown in general form in FIG. 1 with various embodiments of fastening means therefor taken into consideration. FIG. 2A and FIG. 2B provide some additional details regarding such fastening means. For example, FIG. 2A provides complementary female threads 257A of a locking ring 258A or locking collar 258B around a male connector 259 of the tip 156 of the sampling port access device 150, configured to mate with complementary male threads 244A around a female connector 246 of the urine sampling port 142, according to some embodiments. And, for example, FIG. 2B provides complementary male threads 257B around a male connector 259 of the tip 156 of the sampling port access device 150, configured to mate with complementary female threads 244B of a female connector 246 of the urine sampling port 142, according to some embodiments.

[0041] As described below, Figures 3A-3B, 4A-4F, and 5A-5L provide further details regarding the complementary threads of Figures 2A and 2B, including various thread patterns and their thread forms that may be combined in any combination. Figures 3A and 3B provide schematic diagrams illustrating substrates having thread patterns of different handedness. Figures 4A-4F illustrate the use of one or more Thread 3A, 3B, 4A-4F, and 5A-5L, each of the referenced substrates may be independently, for example, an inner surface of a locking ring 258A or a locking collar 258B of the tip 156 of the sampling port access device 150, an outer surface of a male connector 259 of the tip 156 of the sampling port access device 150, or an outer or inner surface of a female connector 246 of a urine sampling port 142 of a connector 140.

[0042] Thread Pattern FIG. 3A provides a schematic diagram illustrating a substrate 300A including threads 310A having a right-hand thread pattern, according to some embodiments.

[0043] Two pieces having complementary threads with a right-hand thread pattern, such as that shown in Figure 3A, are assembled by driving one of the pieces onto or into the other of the two pieces in a clockwise direction via the complementary threads. For example, if a first piece, such as tip 156 of sampling port access device 150, and a second piece, such as urine sampling port 142 of connector 140, have complementary right-hand threads, tip 156 of sampling port access device 150 is driven onto or into urine sampling port 142 in a clockwise direction via the complementary right-hand threads.

[0044] FIG. 3B provides a schematic diagram illustrating a substrate 300B including screws 310B having a left-handed thread pattern, according to some embodiments. Two pieces having complementary threads with a left-handed thread pattern, such as that shown in Figure 3B, are assembled by driving one of the pieces onto or into the other of the two pieces in a counterclockwise direction via the complementary threads. For example, if a first piece, such as tip 156 of sampling port access device 150, and a second piece, such as urine sampling port 142 of connector 140, have complementary left-handed threads, tip 156 of sampling port access device 150 is driven onto or into urine sampling port 142 in a counterclockwise direction via complementary left-handed threads.

[0045] FIG. 4A illustrates a block diagram of a single Thread 4 provides a schematic diagram showing a substrate 400A with screws 410A having a thread pattern including: As shown, one of the screws 410A Thread teeth Thread 412A, which can have any thread form such as the thread form shown in FIG. 4A or any one of the thread forms in FIGS. 5A-5H. Thread412A is larger than the substrate diameter of substrate 400A Thread Generally, Thread of Thread Straight The difference between the diameter and the substrate diameter is Thread Equal to the height or depth of. For example, Thread 412A Thread The difference between the diameter, i.e., the “large diameter”, and the substrate diameter, i.e., the “small diameter”, of substrate 400A is Thread 412A. The height or depth is found by difference whether the substrate is cylindrical, like substrate 400A in FIG. 4A, or tapered, like male connector 259 at tip 156 of sampling port access device 150. Thread The height or depth of the may vary depending on several factors. For example, Thread The thickness of the board into which it is screwed is a factor as to how deep the screw can be threaded without losing the structural integrity of the board.

[0046] As further shown, thread 410A has a pitch, which refers to the distance between adjacent similar points or locations, such as adjacent crests or valleys on a thread (see FIG. 5E for identifying the crests and valleys of a thread). Thread (i.e. Thread In the case of thread 410A having a pitch of 412A, the pitch is, for example, Thread Thread 410A also has a lead pitch, or "lead," which is equal to the distance between adjacent crests (apexes) of thread 412A. Thread It indicates the distance between adjacent similar points or locations (e.g., adjacent peaks, valleys, etc.) of a Thread (i.e. Thread In the case of the screw 410A having a lead pitch of 412A, the lead pitch is, for example, Thread The pitch of the thread 410A and the distance between adjacent vertices of the thread 412A are equal to each other. Thread The lead pitch of 412A is the same, however this is not always the case as shown in Figures 4B, 4C, and 4D.

[0047] FIG. 4B illustrates two Thread FIG. 4D provides a schematic diagram showing a substrate 400B with screws 410B having a first thread pattern including: Thread 4 provides a schematic diagram showing a substrate 400D with screws 410D having a second thread pattern including:

[0048] As shown, two of the screws 410B Thread teeth, Thread 412A and additional Thread Similarly, two of the screws 410D Thread teeth, Thread 412A and additional Thread However, the two screws 410B Thread are substantially similar with respect to their relative size and thread form, but the two of thread 410D Thread are different at least with respect to their relative sizes. In fact, the two screws 410B or 410D Thread Of these, Thread 5A-5H. Thus, the threads 410B, etc., can be independently configured with respect to their relative size and thread form, e.g., any one of the thread forms of FIGS. Nijo Configuration of two screws Thread 4B. Alternatively, the screw 410D, etc. Nijo Configuration of two screws Thread may differ in terms of relative size, thread form, or a combination thereof (see, for example, Figures 5I-5K).

[0049] In this case too, Thread of Thread The difference between the diameter and the substrate diameter of the substrate is Thread Equal to the height or depth of. For example, Thread 412A Thread The difference between the diameter of the substrate 400B and the diameter of the substrate 400B is Thread Equal to the height of 412A Thread 412B Thread The difference between the diameter of the substrate 400B and the diameter of the substrate 400B is ThreadAs shown in FIG. 4B, Thread The heights of 412A and 412B are substantially similar. Thread 412A Thread The difference between the diameter and the diameter of the substrate 400D is Thread Equal to the height of 412A Thread 412D Thread The difference between the diameter and the diameter of the substrate 400D is Thread However, as shown in FIG. Thread The height of 412A and 412D is Thread The height of 412A Thread It differs in that it is taller than the 412D. Thread The height or depth of the may vary depending on several factors. For example, Thread The thickness of the board into which the screws are threaded is a factor of how deep the deepest of two or more screws can be threaded without losing the structural integrity of the board.

[0050] As further shown, each thread of threads 410B and 410D has a pitch, which also refers to the distance between adjacent similar points or locations, such as adjacent crests or valleys, of the thread. Thread (i.e. Thread 412A and Thread 412B), the pitch is, for example, Thread The apex of 412A and Thread 412B. Similarly, the pitch of thread 410D is, for example, equal to the distance between adjacent vertices of thread 412B. Thread The apex of 412A and Thread Each thread of threads 410B and 410D also has a lead pitch, which is also equal to the distance between adjacent vertices of threads 412B and 412D. Thread It indicates the distance between two adjacent similar points or locations (e.g., adjacent peaks, valleys, etc.) of a Thread (i.e. Thread 412A and Thread In the case of screw 410B having a groove 412B, Thread For example, the lead pitch of 412A is ThreadEqual to the distance between adjacent vertices of 412A, Thread For example, the lead pitch of 412B is Thread 412B. Similarly, for screw 410D, Thread For example, the lead pitch of 412A is Thread Equal to the distance between adjacent vertices of 412A, Thread The lead pitch of 412D is, for example, equal to the distance between adjacent vertices. As shown in either FIG. 4B or FIG. 4D, if the thread has two ends, such as thread 410B or thread 410D, Thread If the thread has a pitch of Thread The lead pitch can be half that of the lead.

[0051] FIG. 4F illustrates three Thread 4 provides a schematic diagram showing a substrate 400F with screws 410F having a thread pattern including: As shown, the three screws 410F Thread teeth, Thread 412A, Thread 412B, and additional Thread Includes 412F. Three screws 410F Thread are substantially similar with respect to their relative size and thread form, but the three threads of thread 410D are Thread Of these, Thread 5A-5H. Thus, the threads 410F, etc., can be independently configured with respect to their relative size and thread form, e.g., any one of the thread forms of FIGS. Sanjo Configuration of three screws Thread may all be substantially similar as shown in FIG. Sanjo Any two of the screws in the configuration Thread may be substantially similar, but the third thread Thread may differ in terms of relative size, thread form, or a combination thereof (see, e.g., Figures 5I-5K). Sanjo Configuration of three screws Thread may all differ in terms of relative size, thread form, or a combination thereof (see, for example, FIG. 5L).

[0052] In this case too, Thread of Thread The difference between the diameter and the substrate diameter of the substrate is Thread Equal to the height or depth of. For example, Thread 412A Thread The difference between the diameter and the diameter of the substrate 400F is Thread Equal to the height of 412A Thread 412B Thread The difference between the diameter and the diameter of the substrate 400F is Thread Equal to the height of 412B Thread 412F Thread The difference between the diameter and the diameter of the substrate 400F is Thread As shown in Figure 4F, Thread The heights of 412A, 412B, and 412F are substantially similar. However, the height of the screw 410D in FIG. Thread As with the height of 412A and 412D, Sanjo Any two of the screws in the configuration Thread The height of the third screw may be substantially similar. Thread The heights of the vertices are different (see, for example, Figures 5I to 5K). Sanjo Configuration of three screws Thread All the heights may be different. Thread The height or depth of the may vary depending on several factors. For example, Thread The thickness of the board into which the screws are threaded is a factor of how deep the deepest of the three or more screws can be threaded without losing the structural integrity of the board.

[0053] As further shown, thread 410F has a pitch, which also refers to the distance between adjacent similar points or locations, such as adjacent crests or valleys, of the thread. Thread (i.e. Thread 412A, Thread 412B, and Thread 412F), the pitch is, for example, Thread The apex of 412A and ThreadEach of the threads 410A, 410B, and 410F also has a lead pitch, which is also equal to the distance between adjacent vertices of the threads 410A, 410B, and 410F. Thread It indicates the distance between adjacent similar points or locations (e.g., adjacent peaks, valleys, etc.) of three Thread (i.e. Thread 412A, Thread 412B, and Thread In the case of screw 410F having 412F, Thread For example, the lead pitch of 412A is Thread Equal to the distance between adjacent vertices of 412A, Thread For example, the lead pitch of 412B is Thread Equal to the distance between adjacent vertices of 412B, Thread For example, the lead pitch of 412F is Thread As shown in FIG. 4F, if the thread has three ends like thread 410F, the distance between the adjacent ends is equal to the distance between the adjacent ends of thread 412F. Thread If the thread has a pitch of Thread The lead pitch can be one-third of the lead pitch.

[0054] With respect to the pitch of the threads, such as any one of threads 410A, 410B, 410D, and 410F of Figures 4A, 4B, 4D, and 4F, the pitch of the threads, in some embodiments, is at least 0.25 mm, 0.50 mm, 0.75 mm, 1.00 mm, 1.25 mm, 1.50 mm, 1.75 mm, 2.00 mm, 2.25 mm, 2.50 mm, 2.75 mm, 3.00 mm, 3.25 mm, 3.50 mm, 3.75 mm, 4.00 mm, 4.25 mm, 4.50 mm, 4.75 mm, or 5.00 mm. In some embodiments, the pitch of the threads is 5.00 mm, 4.75 mm, 4.50 mm, 4.25 mm, 4.00 mm, 3.75 mm, 3.50 mm, 3.25 mm, 3.00 mm, 2.75 mm, 2.50 mm, 2.25 mm, 2.00 mm, 1.75 mm, 1.50 mm, 1.25 mm, 1.00 mm, 0.75 mm, 0.50 mm, or 0.25 mm or less. Thus, in some embodiments, the pitch of the threads is at least 1.00 mm and 4.00 mm or less, including at least 0.50 mm and 4.50 mm or less, such as at least 2.00 mm and 3.00 mm or less. With respect to the lead pitch of a thread, such as any one of threads 410A, 410B, 410D, and 410F, the lead pitch of the threads is the pitch of the threads. Thread Depending on the number of pitches (e.g., 2, 3, 4, etc.), the resulting pitch will be a multiple (e.g., 2x, 3x, 4x, etc.) of any of the aforementioned pitches or ranges of pitches.

[0055] In view of the foregoing, the urine sampling port 142 of the connector 140 of the catheter assembly 110 may, in some embodiments, be configured with a left-handed thread pattern, a first Thread The second Thread Greater than Thread Thread pattern with diameter, three Thread More than two like Thread or three Thread More than two like ThreadThe urine sampling port 142 includes any thread of a left-handed thread pattern having ... right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a right-handed thread pattern having a left-handed thread pattern having a right-handed thread pattern having a right-handed thread pattern having a left

[0056] Also, in view of the above, the tip 156 at the end of the barrel 152 of the sampling port access device 150 may, in some embodiments, be threaded with a left-handed thread pattern, a first Thread The second Thread Greater than Thread Thread pattern with diameter, three Thread More than two like Thread or three Thread More than two like Thread The sampling port access device 150 may include any thread of a left-handed thread pattern having a tip 156 at the end of the barrel 152 of the sampling port access device 150 configured to mate with complementary threads of a sampling port of another device, such as, but not limited to, the urine sampling port 142 of the connector 140 of the catheter assembly 110. The complementary threads ensure proper mating of the sampling port access device 150 and the sampling port of the other device for sterile sampling, such as sterile urine sampling or blood sampling.

[0057] Thread Form Figure 4C shows two Thread Section D of Figure 4C provides a schematic diagram showing a cross section of substrate 400B with threads 410B having a first thread pattern including: Section D of Figure 4C is also shown in Figure 5A, which provides a schematic diagram showing first thread form 500A, according to some embodiments.

[0058] Thread form 500A is one or more Thread where one or more Thread Of these, Threadhave the same square thread form in cross section. As exemplified by thread form 500A, a thread, such as any of threads 410A, 410B, 410D, and 410F, can have crests, such as crest 502A, valleys, such as valley 504A, and flanks or faces, such as 506A.

[0059] FIG. 5B provides a schematic diagram illustrating a second thread form 500B, according to some embodiments. Thread form 500B is one or more Thread where one or more Thread Of these, Thread have the same rounded square thread form in cross section. Compared to thread 500A, thread 500B differs in that the peaks and valleys of square thread form 500A are rounded to form rounded square thread form 500B.

[0060] FIG. 5C provides a schematic diagram illustrating a third thread form 500C, according to some embodiments. Thread form 500C is one or more Thread where one or more Thread Of these, Thread have the same trapezoidal thread form in cross section.

[0061] FIG. 5D provides a schematic diagram illustrating a fourth thread form 500D, according to some embodiments. Thread form 500D is one or more Thread where one or more Thread Of these, Thread have the same knuckle-shaped thread form in cross section.

[0062] FIG. 5E provides a schematic diagram illustrating a fifth thread form 500E, according to some embodiments. Thread form 500E is one or more Thread where one or more Thread Of these, Thread5E. All of the threads have the same triangular thread form in cross section. As illustrated by thread form 500E, a thread, such as any of threads 410A, 410B, 410D, and 410F, can have crests, such as crest 502E, valleys, such as valley 504E, and flanks or faces, such as 506E. Additionally, a thread angle 508E between the faces of the thread is shown in FIG. 5E.

[0063] FIG. 5F provides a schematic diagram illustrating a sixth thread form 500F, according to some embodiments. Thread form 500F is one or more Thread where one or more Thread Of these, Thread have the same truncated triangular thread form in cross section. Compared to thread 500E, thread 500F differs in that the crests of triangular thread form 500E are truncated and the roots are flat-threaded to form truncated triangular thread form 500F.

[0064] FIG. 5G provides a schematic diagram illustrating a seventh thread form 500G, according to some embodiments. Screw form 500G is one or more Thread where one or more Thread Of these, Thread have the same triangular thread form in cross section. Compared to thread form 500E, thread form 500G differs in that the triangles in triangular thread form 500E are tilted from an isosceles to a scalene shape to form triangular thread form 500G, which can also be described as a sawtooth thread form.

[0065] FIG. 5H provides a schematic diagram illustrating an eighth thread form 500H, according to some embodiments. Thread form 500A is one or more Thread where one or more Thread Of these, Thread have the same rounded triangular thread form in cross section.

[0066] Figure 4E shows two Thread Section G of Figure 4E provides a schematic diagram showing a cross section of substrate 400D with threads 410D having a second thread pattern including: Section G of Figure 4E is also shown in Figure 5I, which provides a schematic diagram showing a ninth thread form 500I, according to some embodiments.

[0067] Thread form 500I has two or more Thread where two or more Thread The first of Thread has a square thread form in cross section and has two or more Thread The second of Thread also have a square thread form in cross section, but the relative sizes are different.

[0068] FIG. 5J provides a schematic diagram illustrating a tenth thread form 500J, according to some embodiments. Thread form 500J is two or more Thread where two or more Thread The first of Thread has a thread form with a truncated triangular cross section, and has two or more Thread The second of Thread also have a truncated triangular thread form in cross section, but the relative sizes are different.

[0069] FIG. 5K provides a schematic diagram illustrating an eleventh thread form 500K, according to some embodiments. Thread form 500K is two or more Thread where two or more Thread The first of Thread has a thread form with a truncated triangular cross section, and has two or more Thread The second of Thread have square thread forms in cross section, and the thread forms vary in relative size.

[0070] FIG. 5L provides a schematic diagram illustrating a twelfth thread form 500L, according to some embodiments. Screw form 500L is three or more Thread where three or more Thread The first of Thread has a rounded square thread form in cross section and has three or more Thread The second of Thread has a rounded triangular thread form in cross section and has three or more Thread The third of Thread has a knuckle-shaped thread form in cross section.

[0071] method Methods for aseptic urine sampling include, but are not limited to, donning sterile gloves, cleaning a urine sampling port of a catheter assembly, such as the urine sampling port 142 of the connector 140 of the catheter assembly 110, optionally with a disinfectant towel, fluidly connecting a sampling port access device, such as the sampling port access device 150, to the urine sampling port 142, and aspirating a urine sample from the urine sampling port 142.

[0072] The method of sterile urine sampling may also further include clamping the drainage tube 132 of the catheter assembly 110 with a tube clamp between the urine sampling port 142 and a drainage bag of the catheter assembly 110. Clamping the drainage tube 132 with a tube clamp allows urine to be returned to the urine sampling port 142 for urine sampling.

[0073] Additionally, the method for sterile urine sampling may further include color matching the tip 156 of the sampling port access device 150 and the urine sampling port 142 to ensure that the appropriate sampling port access device is used with the catheter assembly 110 for sterile urine sampling. This reduces the risk of urine sample contamination due to an incorrect attempt to connect a sampling port access device foreign to the urine sampling system 100.

[0074] The method for sterile urine sampling may also further include screwing the sampling port access device 150 onto or into the urine sampling port 142 in a clockwise or counterclockwise direction according to complementary right-handed or left-handed threads on the tip 156 of the sampling port access device 150 and the urine sampling port 142 of the connector 140 of the catheter assembly 110.

[0075] Additionally, the method of sterile urine sampling can further include utilizing one or more septum-stopped test tubes and sliding at least one of the one or more test tubes into the barrel 152 of the sampling port access device 150. As the at least one of the one or more test tubes is slid into the barrel 152 of the sampling port access device 150, a hollow needle 154 disposed in the barrel 152 of the sampling port access device 150 pierces the septum stopper of the test tube. As the needle 154 pierces the septum stopper of the test tube, urine is automatically aspirated from the urine sampling port 142 into the test tube due to the subatmospheric internal pressure of the test tube to provide a urine sample.

[0076] Following sterile urine sampling, one or more urine samples in one or more test tubes can be labeled, optionally refrigerated, and then placed in a transport pouch for transport to a laboratory for urinalysis or microbiological analysis.

[0077] Advantages of the urine sampling system and sterile urine sampling method include standardization of clinical practice for collecting urine samples from catheterized patients, eliminating the risks of patient infection, contaminated samples (due to contamination of the sample port), and false-positive urine cultures, and the method of sterile urine sampling ensures compliance with relevant CDC guidelines.

[0078] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these adaptations and / or modifications. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A urine sampling system for sterile urine sampling, comprising: A catheter assembly. a sampling port access device, The catheter assembly includes: A urinary catheter, A drainage tube and a connector fluidly connecting the urinary catheter to the drainage tube, the connector including a urine sampling port having either a thread pattern in which a first thread has a larger thread diameter than a second thread, a thread pattern having more than two threads, or a left-handed thread pattern having more than two threads configured to mate with complementary threads on a distal end of the sampling port access device, thereby ensuring proper mating of the urine sampling port and the sampling port access device for sterile urine sampling; The sampling port access device comprises: Barrel and a hollow needle including a tip, the needle being coaxially disposed within the barrel such that the tip of the needle is protected by the barrel; a tip at an end of the barrel fluidly connected to the needle, the tip of the barrel having either a thread pattern in which a first thread has a larger thread diameter than a second thread, a thread pattern having more than two threads, or a left-handed thread pattern having more than two threads configured to mate with complementary threads on the urine sampling port, thereby ensuring proper mating of the sampling port access device and the urine sampling port for sterile sampling; the tip of the sampling port access device and the urine sampling port each have complementary fastening means for fastening to the other of the tip of the sampling port access device and the urine sampling port, thereby ensuring proper mating of the tip of the sampling port access device and the urine sampling port for sterile urine sampling; The urine sampling system further comprises one or more septum-stopped test tubes; 1. A urine sampling system, wherein each tube of the one or more test tubes has an internal pressure that is less than atmospheric pressure, and each tube of the one or more test tubes is independently configured to contain a urinalysis preparation, a microbiological analysis preparation, or to be free of additives or preservatives.

2. A urine sampling system as described in claim 1, wherein the threads of the urine sampling port include male threads around a female connector of the urine sampling port.

3. A urine sampling system as described in claim 1, wherein the threads of the urine sampling port include female threads of a female connector of the urine sampling port.

4. The urine sampling system of claim 1, wherein the thread of the urine sampling port includes a thread pattern having three threads.

5. A urine sampling system as described in any one of claims 1 to 4, wherein the threads of the urine sampling port include a left-handed thread pattern.

6. A urine sampling system as described in claim 1, wherein the threads of the sampling port access device include female threads of a locking ring or locking collar around the male connector at the tip of the sampling port access device.

7. A urine sampling system as described in claim 6, wherein the locking ring is non-rotatably attached to the barrel or molded with the barrel, and the sampling port access device is configured to engage with the urine sampling port by screwing the entire sampling port access device into the urine sampling port.

8. A urine sampling system as described in claim 6, wherein the locking collar is rotatably attached to the barrel, and the sampling port access device is configured to engage with the urine sampling port by screwing the locking collar of the sampling port access device into the urine sampling port while holding the barrel stationary.

9. A urine sampling system as described in claim 1, wherein the threads of the sampling port access device include male threads around a male connector at the tip of the sampling port access device.

10. A urine sampling system as described in any one of claims 1 to 9, wherein the screw of the sampling port access device includes a left-handed thread pattern having three threads.

11. 2. A urine sampling system as described in claim 1, wherein the complementary fixing means of the tip of the sampling port access device comprises complementary threads configured such that the female threads of a locking ring or rotatable locking collar around the male connector of the tip of the sampling port access device mate with the male threads around the female connector of the urine sampling port.

12. 2. A urine sampling system as described in claim 1, wherein the complementary fastening means of the tip of the sampling port access device comprises complementary threads configured such that male threads around a male connector of the tip of the sampling port access device mate with female threads of a female connector of the urine sampling port.

13. 13. A urine sampling system as described in claim 11 or 12, wherein the screw includes a thread pattern having two or more threads, and at least a first thread of the two or more threads has a larger thread diameter than a second thread of the two or more threads.

14. A urine sampling system according to any one of claims 11 to 13, wherein the screw comprises a thread pattern having three threads.

15. A urine sampling system according to any one of claims 11 to 14, wherein the threads comprise a left-handed thread pattern.

16. A urine sampling system as described in any one of claims 1 to 15, wherein the tip of the sampling port access device and the urine sampling port match the colour of the other of the tip of the sampling port access device and the urine sampling port, respectively, thereby reducing the risk of urine sample contamination due to an attempt to connect the tip of the sampling port access device or the urine sampling port incorrectly.

17. 2. A urine sampling system as described in claim 1, wherein each of the one or more test tubes has an outer diameter that is matched to or smaller than the inner diameter of the barrel of the sampling port access device, such that each test tube can be slid into the barrel and a needle of the sampling port access device can pierce a septum stopper of the test tube for urine sampling.

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