Urine sampling kit and method thereof

Abstract

In some embodiments, a urine sampling kit is disclosed that includes a sampling port access device, a hand sanitizer pack, a pair of sterile gloves, and a packaged disinfectant wipe, wipe, or swab. The sampling port access device comprises a barrel and a hollow needle coaxial with the barrel, and the tip of the end of the barrel is configured to fluidly connect the sampling port access device to the urine sampling port of the catheter assembly. The needle is fluidly connected to but positioned away from the tip of the barrel. Contents of a urine sampling kit are packaged according to a gradual description of sterile urine sampling, including a sampling port access device, a hand sanitizer pack, a pair of sterile gloves and a packaged disinfecting wipe, wet tissue or swab. Also disclosed is a catheter insertion and urine sampling kit comprising at least some of the aforementioned components, as well as a method of sterile urine sampling using a urine sampling kit and a catheter insertion and urine sampling kit.

Description

[0001] Case information

[0002] This application is a divisional application of the invention patent application with application number 201980034646.2 filed on May 21, 2019 and invention name “Urine sampling kit and method thereof”.

[0003] priority

[0004] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 675,112, filed May 22, 2018, which is incorporated herein in its entirety. Background Art

[0005] Hospitals across the country are understandably focusing their efforts on catheter-associated urinary tract infection (“CAUTI”) prevention bundles to achieve better outcomes, limit the risk of Centers for Medicare & Medicaid Services (CMS) reimbursement penalties, and reduce the development of drug resistance. Prevention efforts have historically focused on closed systems, sterile insertion techniques, and maintenance of patients with Foley catheters. However, despite 96% of nursing decision makers believing there is variability in how nurses within their facility collect urine specimens from Foley catheters, to date, little or no widespread attention has been paid to the significant variations associated with urine sampling practices.

[0006] Studies have shown that variability exists in all aspects of urine sampling, including where urine samples are collected from the collection system, how the urine sampling area is cleaned, which equipment is used to collect urine samples, and how urine samples are transferred to the laboratory. This variability is a fundamental issue that affects the documentation of CAUTI results. In fact, 100% of nursing decision makers believe that variability and improper urine sampling technique may lead to increased risk of contamination and, therefore, false-positive CAUTIs. In addition, up to 70% of urine cultures reflect false-positive results, which leads to inaccurate CAUTI diagnoses and inappropriate antibiotic therapy, as well as artificially undermining hospital time and resources dedicated to reducing CAUTI risk through other means. This issue presents an ongoing challenge to those seeking to reduce CAUTI rates to avoid CMS reimbursement penalties.

[0007] Disclosed herein is a urine sampling kit and method thereof that at least solve the above-mentioned problems. Summary of the invention

[0008] A urine sampling kit is disclosed herein, which in some embodiments includes a sampling port access device, a package of hand sanitizer, a pair of sterile gloves, and an antiseptic-saturated material in a clean form packaged for cleaning. The sampling port access device includes a barrel, a tip at one end of the barrel (which is configured to connect the sampling port access device fluid to the urine sampling port of the catheter assembly) and a hollow needle coaxial with the barrel. The needle is fluidly connected to the tip of the barrel but is directed away from the tip of the barrel. The contents of the urine sampling kit are packaged according to step-by-step instructions for sterile urine sampling, which include a sampling port access device, a hand sanitizer package, a pair of sterile gloves, and an antiseptic-saturated material in a clean form package.

[0009] In some embodiments, the urine sampling kit further comprises a fenestrated drape for placement on a patient. The perforations of the drape are configured to allow access to a urine sampling port of the catheter assembly when the drape is placed over the patient.

[0010] In some embodiments, the urine sampling kit further comprises a tubing clamp configured to clamp the drainage tubing between the urine sampling port of the catheter assembly and the drainage bag. Clamping the drainage tubing with the tubing clamp allows urine to return to the urine sampling port for urine sampling.

[0011] In some embodiments, the urine sampling kit further comprises one or more septum-stoppered test tubes. Each of the one or more test tubes has an internal pressure less than atmospheric pressure.

[0012] In some embodiments, each of the one or more test tubes is independently configured to include a formulation for urinalysis, a formulation for microbiological analysis, or to exclude additives or preservatives therein.

[0013] In some embodiments, the urine sampling kit further comprises a central supply chamber ("CSR") wrap wrapped around the contents of the urine sampling kit. The CSR wrap is configured to maintain the sterility of the contents of the urine sampling kit while being wrapped around the contents of the urine sampling kit.

[0014] In some embodiments, the urine sampling kit further comprises a molded tray comprising one or more compartments configured to hold the contents of the urine sampling kit.

[0015] In some embodiments, the urine sampling kit further comprises an outer packaging of the urine sampling kit. The outer packaging is configured to protect the urine sampling kit from damage and loss of components of the urine sampling kit from the point of manufacture of the urine sampling kit to the point of use of the urine sampling kit.

[0016] In some embodiments, the urine sampling kit further comprises a molded tray, a CSR wrapper, and an outer packaging. The molded tray comprises one or more compartments configured to hold the contents of the urine sampling kit. The CSR wrapper is configured to maintain the sterility of the contents of the urine sampling kit while wrapping the CSR wrapper around the molded tray and the contents of the urine sampling kit. The outer packaging of the urine sampling kit is configured to protect the urine sampling kit from damage and loss of components of the urine sampling kit from the point of manufacture of the urine sampling kit to the point of use of the urine sampling kit.

[0017] Also disclosed herein is a catheterization and urine sampling kit, which includes a set of catheterization components and a set of urine sampling components. The set of catheterization components includes a pre-connected catheter assembly, which includes a catheter, a drainage tubing, and a connector for connecting the catheter fluid to the drainage tubing. The connector includes a urine sampling port. The set of urine sampling components includes a sampling port entry device, a hand sanitizer bag, a pair of sterile gloves, and a sterilant saturated material with a clean form of packaging configured for cleaning. The sampling port entry device includes a tip at one end of the barrel, which is configured to connect the sampling port entry device fluid to the urine sampling port of the catheter assembly. The contents of the urine sampling kit are packaged according to the step-by-step instructions for sterile urine sampling, which include a sampling port entry device, a hand sanitizer bag, a pair of sterile gloves, and a sterilant saturated material with a clean form of packaging.

[0018] In some embodiments, the urine sampling port of the connector and the tip of the sampling port access device each have a thread pattern complementary to the other for locking the sampling port access device onto the urine sampling port.

[0019] In some embodiments, the catheterization and urine sampling kit further comprises a first drape and a second drape. The first drape is provided for placement on a patient. The perforations of the first drape are shaped and sized to allow access to the patient for insertion of a urinary catheter when the first drape is draped over the patient. A second drape is also provided for placement on the patient. The perforations of the second drape are shaped and sized to allow access to a urine sampling port when the second drape is draped over the patient.

[0020] In some embodiments, the catheterization and urine sampling kit further comprises a sheet clip for securing the drainage tubing to one or more sheets. The sheet clip is also configured to clamp the drainage tubing between the urine sampling port and the drainage bag of the catheter assembly. Clamping the drainage tubing with the tubing clip allows urine to return to the urine sampling port for urine sampling.

[0021] In some embodiments, the catheterization and urine sampling kit further comprises one or more septum plugged test tubes. Each of the one or more test tubes has an internal pressure less than atmospheric pressure. Each of the one or more test tubes is also independently configured to include therein a preparation for urine analysis, a preparation for microbiological analysis, or no additives or preservatives.

[0022] In some embodiments, the sampling port access device includes a hollow needle coaxial with the barrel of the sampling port access device, wherein the needle is fluidically connected to the tip of the barrel but is oriented away from the tip of the barrel. Each of the one or more test tubes has an outer diameter that is comparable to or less than the inner diameter of the barrel of the sampling port access device. With such design dimensions, each test tube is configured to slide into the barrel of the sampling port access device to pierce the septum plug of the test tube using the needle of the sampling port access device for urine sampling.

[0023] In some embodiments, the catheterization and urine sampling kit further comprises a CSR wrap wrapped around the contents of the catheterization and urine sampling kit. The CSR wrap is configured to maintain the sterility of the contents of the catheterization and urine sampling kit while being wrapped around the contents of the catheterization and urine sampling kit.

[0024] In some embodiments, the catheterization and urine sampling kit further comprises a molded tray comprising one or more compartments configured to hold the contents of the catheterization and urine sampling kit.

[0025] In some embodiments, the catheterization and urine sampling kit further comprises an outer packaging of the catheterization and urine sampling kit. The outer packaging is configured to protect the catheterization and urine sampling kit from damage and loss of components of the catheterization and urine sampling kit from the point of manufacture of the catheterization and urine sampling kit to the point of use of the catheterization and urine sampling kit.

[0026] In some embodiments, the catheterization and urine sampling kit further comprises a molded tray, a CSR wrap, and an outer packaging. The molded tray comprises one or more compartments configured to hold the contents of the catheterization and urine sampling kit. The CSR wrap is configured to maintain the sterility of the contents of the catheterization and urine sampling kit while wrapping the CSR wrap around the molded tray and the contents of the catheterization and urine sampling kit. The outer packaging of the catheterization and urine sampling kit is configured to protect the catheterization and urine sampling kit from damage and loss of components of the catheterization and urine sampling kit from the point of manufacture of the catheterization and urine sampling kit to the point of use of the catheterization and urine sampling kit.

[0027] Also disclosed herein is a method for aseptic urine sampling, comprising removing an outer packaging from a urine sampling kit, aseptically opening the urine sampling kit, cleaning a urine sampling port of a catheter assembly, fluidly connecting a sampling port access device to the urine sampling port, and aspirating a urine sample from the urine sampling port. Removing the outer packaging from the urine sampling kit comprises exposing one or more steps in a set of step-by-step instructions for urine sampling incorporated into the urine sampling kit. Opening the urine sampling kit comprises a sterile work surface forming an inner surface of a CSR package for urine sampling. Opening the urine sampling kit also comprises exposing additional steps of the step-by-step instructions and sterile contents of the urine sampling kit arranged on the sterile work surface. The sterile contents of the urine sampling kit comprise at least a sampling port access device and a sterilant-saturated material of a package having a clean form configured for cleaning. The sampling port access device comprises a tip at one end of the barrel configured to fluidly connect the sampling port access device to the urine sampling port of the catheter assembly. Cleaning the urine sampling port or the catheter assembly comprises cleaning the urine sampling port using a sterilant-saturated material having a clean form.

[0028] In some embodiments, the method for aseptic urine sampling also includes obtaining one or more septum-plugged test tubes and sliding at least one of the one or more test tubes into the barrel of the sampling port access device. One or more septum-plugged test tubes are optionally obtained from a urine sampling kit, if provided therein. Each of the one or more test tubes has an internal pressure less than atmospheric pressure. At least one of the one or more test tubes is slid into the barrel of the sampling port access device to pierce the septum plug of the test tube using a hollow needle arranged in the barrel of the sampling port access device. Once the needle pierces the septum plug of the test tube, urine is automatically drawn into the test tube from the urine sampling port to provide a urine sample due to the internal pressure of the test tube below atmospheric pressure.

[0029] In some embodiments, the method for aseptic urine sampling further comprises clamping the drainage tubing of the catheter assembly between the urine sampling port and the drainage bag of the catheter assembly using a tubing clamp or a bed sheet clamp. Clamping the drainage tubing using the tubing clamp or the bed sheet clamp allows urine to return into the urine sampling port for urine sampling.

[0030] In some embodiments, the method for aseptic urine sampling further comprises aseptically removing a hand sanitizer package provided in the urine sampling kit from the sterile work surface, and then using the hand sanitizer for hand disinfection. In addition, the method for aseptic urine sampling also comprises removing a pair of sterile gloves provided in the urine sampling kit from the sterile work surface, and then wearing a pair of sterile gloves.

[0031] In some embodiments, the method for aseptic urine sampling further comprises wearing a pair of examination gloves before removing the outer packaging from the urine sampling kit. Because the pair of examination gloves may be contaminated by the outer packaging of the urine sampling kit, the method for aseptic urine sampling further comprises removing the pair of gloves after removing the outer packaging from the urine sampling kit. Optionally, after additional hand washing or hand disinfection, the method for aseptic urine sampling further comprises aseptically opening the urine sampling kit to expose the sterile contents of the urine sampling kit. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A schematic diagram is provided showing an unopened urine sampling kit according to some embodiments.

[0033] Figure 2A A schematic diagram is provided showing a first opened urine sampling kit according to some embodiments.

[0034] Figure 2B A schematic diagram is provided showing a second opened urine sampling kit according to some embodiments.

[0035] Figure 3 A schematic diagram is provided showing a dedicated connection between a sampling port access device and a urine sampling port of a connector according to some embodiments. DETAILED DESCRIPTION

[0036] 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 embodiments and optionally combined with or replace the features of any one of the many other embodiments disclosed herein.

[0037] About the terms used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms 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 in a set of features or steps, and do not provide series or numerical restrictions.For example, "first", "second" and "third" features or steps do not have to appear in order, and the specific embodiments including these features or steps do not have to be limited to these three features or steps.For example, "left", "right", "front", "back", "top", "bottom", "front", "back", "clockwise", "counterclockwise", "up", "down" and other marks or other similar terms such as "upper", "lower", "after ...", "before ...", "vertical", "horizontal", "proximal end", "distal end" are for convenience, and are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such marks are used to reflect, for example, relative position, orientation or direction.Unless the context clearly stipulates otherwise, the singular form of "a kind of", "one" and "the" includes plural references.

[0038] For example, the "proximal side", "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be close to 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 close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes an end of the catheter that is intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise states that the proximal portion, proximal portion or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0039] For example, the "distal side", "distal portion" or "distal end portion" of the catheter disclosed herein includes the portion of the catheter that is intended to be close to the patient or in the patient when the catheter is used on the patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that is intended to be close to the patient or in the patient when the catheter is used on the patient. For example, the "distal end" of the catheter includes an end of the catheter that is intended to be close to the patient or in the patient when the catheter is used on the patient. The distal portion, distal portion or distal length of the catheter can include the distal end of the catheter; however, the distal portion, distal portion or distal length of the catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise states that the distal portion, distal portion or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0041] When a patient with a urinary catheter needs a urine sample, the urine sample is collected in one of a variety of different ways using one of a variety of different products to collect the urine sample. Typically, the urine sample is collected using a "clean" procedure that is not sterile and therefore cannot avoid contamination of the urine sample. It has been determined that such changes in urine sampling, including the location where the urine sample is collected from the collection system, how to clean the urine sampling area, what device is used to collect the urine sample, and how the urine sample is transferred to the laboratory, can lead to an increased risk of false positive urine cultures. This in turn may lead to incorrect CAUTI diagnosis and inappropriate antibiotic therapy. Therefore, such changes in urine sampling are a fundamental issue that poses an ongoing challenge to those seeking to reduce CAUTI rates and avoid CMS reimbursement penalties. In addition, Centers for Disease Control (CDC) guidelines state that aseptic techniques should be used when collecting urine from a urinary catheter.

[0042] Disclosed herein is a urine sampling kit and method thereof that solves at least the above problems. For example, the urine sampling kit includes instructions for a step-by-step method of performing sterile urine sampling with a urinary catheter using the contents of the urine sampling kit so as to limit the variation seen in current urine sampling practices. The urine sampling kit provides a single kit solution for performing sterile urine sampling from a urinary catheter.

[0043] The urine sampling kit can be independently used as a separate urine sampling kit, or the urine sampling kit can be integrated into a catheterization kit as a combined catheterization and urine sampling kit. The description of the urine sampling kit applies to both types of sampling kits; however, for the combined catheterization and urine sampling kit, it includes separate parts because such a kit includes additional catheterization contents and arrangements thereof.

[0044] Urine sampling kit

[0045] Figure 1 A schematic diagram is provided showing an unopened urine sampling kit 100 according to some embodiments. Figure 1 In addition to the urine sampling kit 100 of the unopened urine sampling kit shown, the urine sampling kit 100 is also generally referred to as the urine sampling kit disclosed herein, such as Figure 2A and 2B Any one of the urine sampling kits 200A and 200B shown, respectively. The context determines the meaning.

[0046] As shown, the urine sampling kit 100 may include an outer packaging 102 of the urine sampling kit 100, a wrapper or wrapper 104 surrounding the contents of the urine sampling kit 100, and information providing materials 106. The information providing materials 106 may include one or more product labels, brochures, general instructions, instructions for use, patient or family education cards, sticker sheets (for process-related labeling), etc.

[0047] The outer packaging 102 may be configured to protect the urine sampling kit 100 from damage and loss of components of the urine sampling kit 100 from the point of manufacture of the urine sampling kit 100 to the point of use of the urine sampling kit 100. The outer packaging 102 may be a plastic such as high-density polyethylene ("HDPE"), low-density polyethylene ("LDPE"), linear low-density polyethylene ("LLDPE"), medium-density polyethylene ("MDPE"), polyethylene terephthalate ("PET"), polypropylene ("PP"), wait.

[0048] The wrap or wrap 104 surrounding the contents of the urine sampling kit 100 may include a CSR wrap wrapped or rolled around the contents of the urine sampling kit 100. The CSR wrap may be configured to maintain the sterility of the contents of the urine sampling kit 100 while the CSR wrap is wrapped around the contents of the urine sampling kit 100.

[0049] The information providing material 106 may include a label, card or tape surrounding the wrapper or wrapper 104, which includes instructions for one or more steps in a set of step-by-step instructions incorporated into the urine sampling kit 100 for preparing a patient for urine sampling and collecting a urine sample. Additional steps of the step-by-step instructions are provided with the aid of more information providing materials 106 within the urine sampling kit 100.

[0050] Although not in Figure 1 , the urine sampling kit 100 may include one or more hand cleaning or disinfecting products within an outer package 102, but on top of a wrapper or wrapper 104, and information providing material 106. Such hand cleaning or disinfecting products include one or more packages of disinfecting wipes, hand sanitizers, and the like.

[0051] Figure 2A A schematic diagram is provided showing a first opened urine sampling kit 200A according to some embodiments. The urine sampling kit 200A may be Figure 1 The urine sampling kit 100, wherein the outer packaging 102 is removed and as Figure 1 The wrapper or flap of the wrapper 104 is shown turned over around the contents of the urine sampling kit 100 .

[0052] As shown, the urine sampling kit 200A may include a plurality of sterile contents of the urine sampling kit 200A disposed on a sterile work surface 105, which is the inner surface of a wrap or wrap 104. The contents may include, but are not limited to, a sampling port access device 110, a hand sanitizer packet 122, a pair of sterile gloves 124, and a packaged germicidal saturated material having a clean form 132 configured for cleaning (such as a packaged disinfectant wipe, wet wipe, or swab). The contents of the urine sampling kit, including the sampling port access device 110, the hand sanitizer packet 122, the pair of sterile gloves 124, and the packaged germicidal saturated material having a clean form 132, may be packaged according to step-by-step instructions for sterile urine sampling. When one or more of the contents are removed from the urine sampling kit 100, some instructions may be exposed or revealed, which may include changes in urine sampling.

[0053] The sampling port access device 110 may include a barrel 312, a tip 314 at one end of the barrel 312 (which is configured to fluidly connect the sampling port access device 110 to a urine sampling port 322 of the catheter assembly 300), and a hollow needle 316 coaxial with the barrel 312. The needle 316 is fluidly connected to the tip 314 of the barrel but is positioned away from the tip 314 of the barrel (see the barrel 312, tip 314 and needle 316 of the sampling port access device 110 and the urine sampling port 322 of the catheter assembly 300). Figure 3 ).

[0054] The urine sampling kit 200A may further include a drape 134 for placement on a patient when preparing to collect a urine sample and while collecting a urine sample. The shape and size of the perforations of the drape may be designed to allow access to the urine sampling port 322 of the catheter assembly 300 when the drape 134 is draped over the patient. The drape 134 is configured to provide a protective covering that prevents the urine sampling port 322 from being contaminated by, for example, fecal matter or pathogens from another source, thereby reducing urine sample contamination that may otherwise result in a false positive result. The drape 134 may also result in a reduced risk of CAUTI due to the migration of microorganisms on the outer surface of the catheter.

[0055] Figure 2B A schematic diagram is provided showing a second opened urine sampling kit 200B according to some embodiments. The urine sampling kit 200B may be Figure 1 The urine sampling kit 100, wherein the outer packaging 102 is removed and as Figure 1 The flap of the wrapper or wrapper 104 is shown opened around the contents of the urine sampling kit 100 .

[0056] As shown, the urine sampling kit 200B may include a variety of sterile contents of the urine sampling kit 200A and additional contents of the urine sampling kit 200A arranged on the sterile work surface 105. The additional contents may include, but are not limited to, a drape 134, a tubing clamp 136, and one or more septum-stopped test tubes 140. In addition, the contents of any urine sampling kit disclosed herein may be in a molded tray 108, such as Figure 2B shown.

[0057] The molded tray 108 may include one or more compartments configured to hold the contents of the urine sampling kit 100. Step-by-step instructions for sterile urine sampling, such as using the urine sampling kit 100, in the informational material 106 may be distributed in one or more compartments. Again, some instructions may even be exposed or revealed when one or more of the contents are removed from the urine sampling kit 100. In this case, the instructions may be molded into the molded tray 108 or written on the molded tray 108.

[0058] The molded tray 108 may be molded, for example, from high impact polystyrene (“HIPS”). Due to the molding process, the molded tray 108 has one or more molded characteristics, which may include minor imperfections that do not affect the performance of the molded tray 108 .

[0059] The tubing clamp 136 may be configured to clamp the drainage tubing 332 between the urine sampling port 322 and the drainage bag of the catheter assembly 300 (see Drainage Tubing 332, Urine Sampling Port 322 and Catheter Assembly 300). Figure 3 ). Clamping the drainage tubing 332 using the tubing clamp 136 allows urine to return to the urine sampling port 322 for urine sampling.

[0060] Each of the one or more test tubes 140 can be plugged and evacuated to have an internal pressure less than atmospheric pressure. In addition, each of the one or more test tubes can be round-bottomed or conical to accommodate different analytical instruments. In addition, each of the one or more test tubes can have an outer diameter that is comparable to or less than the inner diameter of the barrel 312 of the sampling port access device 110. With such design dimensions, each test tube is configured to slide into the barrel 312 of the sampling port access device 110 to pierce the septum plug of the test tube using the needle 316 of the sampling port access device 110 for urine sampling (see the barrel 312, tip 314 and needle 316 of the sampling port access device 110 for details). Figure 3 ).

[0061] Each of the one or more test tubes can also be independently configured to include therein a formulation for urinalysis, a formulation for microbiological analysis, or to be free of additives or preservatives. The formulation for urinalysis can include chlorhexidine, ethyl paraben, and sodium propionate to ensure the integrity of the sample at room temperature for up to at least 72 hours while preventing the overgrowth of existing microorganisms. The formulation for microbiological analysis can include boric acid, sodium formate, and sodium borate to maintain sample integrity at room temperature for up to at least 48 hours while preventing overgrowth or false positives and without causing toxicity to existing microorganisms.

[0062] In view of the above, the urine sampling kit 100 may include a molded tray 108, a CSR wrap, and an outer packaging 102. The molded tray 108 may include one or more compartments configured to hold the contents of the urine sampling kit 100, which may include, but is not limited to, a sampling port access device 110, a hand sanitizer packet 122, a pair of sterile gloves 124, a sterilant saturated material with a clean form 132 package, a hole towel 134, a tubing clamp 136, one or more septum plugged test tubes 140, or a combination thereof. The information providing material 106 is also included in one or more compartments, and optionally even molded into or written on the molded tray 108. The CSR wrap may be configured to maintain the sterility of the contents of the urine sampling kit 100 while the CSR wrap is wrapped around the molded tray 108 and the contents of the urine sampling kit 100. The outer packaging 102 of the urine sampling kit 100 may be configured to protect the urine sampling kit 100 from damage and loss of components of the urine sampling kit 100 from the point of manufacture of the urine sampling kit 100 to the point of use of the urine sampling kit 100 .

[0063] Combined Catheterization and Urine Sampling Kit

[0064] As described above, the urine sampling kit can exist alone or be integrated into the catheter insertion kit to form a combined catheter insertion and urine sampling kit. Such a catheter insertion and urine sampling kit can include the urine sampling kit 100 or a variant thereof as described above, combined with the features of the catheter insertion kit disclosed in the following co-pending patent applications entitled "Catheter Insertion Tray with Integrated Instructions": U.S. Patent Application No. 15 / 029,613, which was filed as a national phase application of International Patent Application No. PCT / US14 / 60963 filed on October 16, 2014, and published as US2016-0228676; and U.S. Patent Application No. 15 / 487,297 filed on April 13, 2017 and published as US2017-0216558, each of which is incorporated by reference in its entirety into this application.

[0065] The catheterization and urine sampling kit may include a complete set of catheterization components and a complete set of urine sampling components. Figure 3 As shown in , the set of catheter insertion components may include a pre-connected catheter assembly 300, which includes a urinary catheter 310 (e.g., a Foley catheter), a drainage tubing 332, and a connector 320 that fluidly connects the urinary catheter 310 to the drainage tubing 332. The connector 320 may include a urine sampling port 322. The set of urine sampling components may include, for example, Figure 2A and 2B The sampling port access device 110, hand sanitizer package 122, pair of sterile gloves 124 and packaged disinfectant saturated material having a clean form 132 are shown and described in relation thereto. Optionally, the urine sampling kit may also include Figure 2B One or more septum-stopped test tubes 140 are shown and described in relation thereto. The contents of the urine sampling kit 100 are packaged according to step-by-step instructions for sterile urine sampling, and include a sampling port access device 110, a hand sanitizer packet 122, a pair of sterile gloves 124, and a packaged sterilant saturated material having a clean form 132. Providing the contents of the catheterization kit with the contents of the urine sampling kit 100 effectively utilizes a dedicated connection between the sampling port access device 110 and the urine sampling port 322 of the catheter assembly 300, thereby further ensuring that the urine sample is collected aseptically without equipment mismatch errors that could contaminate the urine sample.

[0066] The catheterization and urine sampling kit may further include a first drape and a second drape, such as drape 134. The first drape may be provided for placement on a patient. The perforations of the first drape may be shaped and sized to allow access to the patient for insertion of the urinary catheter 310 when the first drape is draped over the patient. A second drape (e.g., drape 134) may also be provided for placement on the patient. The perforations of the second drape may be shaped and sized to allow access to the urine sampling port 322 when the second drape is draped over the patient. The catheterization and urine sampling kit may further include a protective drape to protect the urine sampling port 322 prior to an initial urine sampling event and between multiple urine sampling events.

[0067] The catheterization and urine sampling kit may further include a sheet clip for securing the drainage tubing 332 to one or more sheets. The sheet clip may also be configured to clamp the drainage tubing 332 between the urine sampling port 322 and the drainage bag of the catheter assembly 300, thereby avoiding the need for a separate tubing clip, such as Figure 2BThe tubing clamp 136 shown and described in connection therewith. That is, the tubing clamp 136 can be provided in the catheterization and urine sampling kit to allow the drainage tubing 332 to be secured to one or more sheets using a bed sheet clamp while clamping the drainage tubing 332 using the tubing clamp 136. Clamping the drainage tubing 332 using the bed sheet clamp allows urine to return into the connector 320 and the urine sampling port 322 for urine sampling.

[0068] The catheterization and urine sampling kit may further include a molded tray, a wrap or wrap (e.g., a CSR wrap), an outer packaging, or a combination thereof, such as Figure 1 , 2A and 2B and the related description thereof. The molded tray may include one or more compartments configured to hold the contents of a catheterization and urine sampling kit, which may include, but is not limited to, a set of catheterization components (e.g., a fluid pre-connected catheter assembly 300 including a urinary catheter 310, drainage tubing 332, and a connector 320, a first drape, a sheet clip, or a combination thereof) and a set of urine sampling components (e.g., a sampling port access device 110, a hand sanitizer package 122, a pair of sterile gloves 124, a sterilant saturated material packaged in a clean form 132, a second drape, a tubing clip 136, one or more septum plugged test tubes 140, or a combination thereof). Information providing materials such as information providing materials 106 may also be included in one or more compartments of the molded tray, and optionally even molded into or written on the molded tray. The CSR wrap can be configured to maintain the sterility of the contents of the catheterization and urine sampling kit while the CSR wrap is wrapped around the molded tray and the contents of the catheterization and urine sampling kit. The outer packaging of the catheterization and urine sampling kit can be configured to protect the catheterization and urine sampling kit from damage and loss of components of the catheterization and urine sampling kit from the point of manufacture of the catheterization and urine sampling kit to the point of use of the catheterization and urine sampling kit.

[0069] Dedicated connection for sampling port access to the device

[0070] Figure 3 A schematic diagram is provided showing a dedicated connection between a sampling port access device and a urine sampling port of a connector according to some embodiments.

[0071] like Figure 3As shown, the sampling port access device 110 includes a tip 314 at one end of the barrel 312, and the tip 314 is configured to fluidly and exclusively connect the sampling port access device 110 to the urine sampling port 322 of the catheter assembly 300. Each of the urine sampling port of the connector 320 and the tip 314 of the sampling port access device 110 has a thread pattern that is complementary to each other for locking the sampling port access device 110 on the urine sampling port 322. An embodiment of a urine sampling port device with a dedicated connection is disclosed in U.S. Provisional Application No. 62 / 674,956, entitled “Systems For Aseptic Urine Sampling And Methods Thereof,” filed on May 22, 2018, which is incorporated herein by reference in its entirety.

[0072] method

[0073] The contents of the urine sampling kit 100 or the catheterization and urine sampling kit are packaged with step-by-step instructions for a sterile urine sampling method. Such step-by-step instructions include how to aseptically prepare a patient for a urine sample, collect a urine sample from a patient using the urine sampling port 322 of the catheter assembly 300, and complete the collection of a urine sample from a patient, thereby reducing healthcare-associated infections (HAIs), such as CAUTIs. The sterile urine sampling method will be described in terms of using the urine sampling kit 100, and it should be understood that the method is also applicable to urine sampling using a catheterization and urine sampling kit.

[0074] The method for aseptic urine sampling includes but is not limited to removing the outer packaging from the urine sampling kit, such as removing the outer packaging 102 from the urine sampling kit 100, aseptically opening the urine sampling kit 100, cleaning the urine sampling port of the catheter assembly, such as the urine sampling port 322 of the catheter assembly 300, optionally, before or after aseptically opening the urine sampling kit 100, fluidly connecting a sampling port access device (e.g., the sampling port access device 110) to the urine sampling port 322, and aspirating a urine sample from the urine sampling port 322.

[0075] Removing the outer packaging 102 from the urine sampling kit 100 includes exposing one or more steps in a set of step-by-step instructions for urine sampling incorporated into the urine sampling kit 100. Any additional materials, such as brochures or educational cards, providing information materials 106 about the contents of the urine sampling kit 100 can be set aside, and the outer packaging 102 and any additional packaging can be appropriately discarded. Removing the outer packaging 102 from the urine sampling kit 100 can further include exposing the hand sanitizer 122 for hand disinfection and the antiseptic saturated material of the package having the cleaning form 132.

[0076] The urine sampling kit 100 is opened, for example, by unrolling the roll of the CSR wrapper around the contents of the urine sampling kit 100 or by turning over a corner of the CSR wrapper (see Figure 1 ), including a sterile work surface 105 forming the inner surface of a CSR package for urine sampling. Opening the urine sampling kit 100 also includes the additional steps of exposing step-by-step instructions and opening the sterile contents of the urine sampling kit 100 on the sterile work surface 105. The sterile contents of the urine sampling kit include those packaged within the package or wrapper 104, such as at least the sampling port access device 110 and the packaged sterilant saturated material having the clean form 132.

[0077] Cleaning the urine sampling port or catheter assembly includes cleaning the urine sampling port using a material saturated with a germicide in a cleaning form.

[0078] The method for aseptic urine sampling can further include obtaining one or more septum plugged test tubes 140 and sliding at least one of the one or more test tubes 140 into the barrel 312 of the sampling port access device 110. The one or more septum plugged test tubes 140 are optionally obtained from the urine sampling kit 100, if provided therein. If not provided in the urine sampling kit 100, the one or more test tubes 140 can be obtained from, for example, a central supply department. At least one of the one or more test tubes 140 is slid into the barrel 312 of the sampling port access device 110 to pierce the septum plug of the test tube using a hollow needle 316 disposed in the barrel 312 of the sampling port access device 110. Once the needle 316 pierces the septum plug of the test tube, urine is automatically aspirated from the urine sampling port 322 to the test tube to provide a urine sample because the internal pressure of the test tube is lower than atmospheric pressure.

[0079] The method for aseptic urine sampling may further include clamping the drainage tubing 332 of the catheter assembly 300 using a tubing clamp 136 (or a sheet clamp of the catheterization and urine sampling kit) between the urine sampling port 322 and the drainage bag of the catheter assembly 300. Clamping the drainage tubing 332 by the tubing clamp 136 (or sheet clamp) allows urine to return into the urine sampling port 322 for urine sampling.

[0080] The method for aseptic urine sampling may further include aseptically removing the hand sanitizer package 122 (if so provided) provided in the urine sampling kit 100 from the sterile work surface 105, and then using the hand sanitizer 122 for hand disinfection. In addition, the method for aseptic urine sampling may further include removing the pair of sterile gloves 124 provided in the urine sampling kit 100 from the sterile work surface 105, and then wearing the pair of sterile gloves 124.

[0081] In some embodiments, the method for sterile urine sampling may further include washing hands or hand disinfection and then wearing a pair of examination gloves before removing the outer package 102 from the urine sampling kit 100. Because the pair of examination gloves may be contaminated by the outer package 102 of the urine sampling kit 100, the method for sterile urine sampling may further include removing the pair of examination gloves after removing the outer package 102 from the urine sampling kit 100. Optionally, after additional hand washing or hand disinfection, the method for sterile urine sampling may further include aseptically opening the urine sampling kit 100 to expose the sterile contents of the urine sampling kit.

[0082] Following the sterile urine sampling method, one or more urine samples in one or more test tubes may be labeled, optionally frozen, and then placed in a transport bag for transport to a laboratory for urinalysis or microbiological analysis.

[0083] The urine sampling kit 100 and the catheterization and urine sampling kit can be manufactured by first manufacturing the contents of the urine sampling kit 100 and the catheterization and urine sampling kit. A molded tray (e.g., molded tray 108) can be molded according to the urine sampling kit 100 or the catheterization and urine sampling kit and filled with its contents. The molded tray can be wrapped in a wrap or wrap 104 (e.g., a CSR wrap) and placed in a bag of an outer packaging 102. Once loaded into the bag of the outer packaging 102, the entire urine sampling kit 100 or the catheterization and urine sampling kit can be sterilized by gas sterilization and sealed in the bag.

[0084] Advantages of the urine sampling kit 100 or catheterization and urine sampling kit and sterile urine sampling method include standardization of clinical practice for collecting urine samples from catheterized patients, thereby eliminating the risk of patient infection, sample contamination (due to sample port contamination) and false positive urine cultures. In addition, the sterile urine sampling method ensures compliance with CDC guidelines related thereto.

[0085] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. A person of ordinary skill in the art may conceive of additional adaptations and / or modifications, and in a broader aspect, these adaptations and / or modifications are also included. Therefore, without departing from the scope of the concepts provided herein, it is possible to deviate from the specific embodiments disclosed herein.

Claims

1. A urine sampling kit, comprising: A sampling port entry device, the sampling port entry device comprising: Cylinder; a tip at one end of the barrel, the tip being configured to introduce fluid into the sampling port of the device and being specifically connected to a urine sampling port of a catheter assembly; and a hollow needle coaxial with the barrel, the needle being fluidly connected to the tip of the barrel but positioned distally from the tip of the barrel; Hand sanitizer packets; Pairs of sterile gloves; a sterilant-saturated material in a clean form packaged in a clean form configured for cleaning; and a drape for placement on a patient, the drape having perforations of a shape and size that allow dedicated access to the urethral sampling port of the catheter assembly when the drape is draped over the patient, The contents of the urine sampling kit are packaged according to step-by-step instructions for sterile urine sampling, the contents including the sampling port access device, the hand sanitizer package, the pair of sterile gloves, and the sterilant saturated material in a clean form package.

2. The urine sampling kit according to claim 1, further comprising a tubing clamp configured to clamp a drainage tubing between the urine sampling port of the catheter assembly and a drainage bag, thereby allowing urine to return into the urine sampling port for urine sampling.

3. The urine sampling kit according to claim 1 further comprises one or more septum-plugged test tubes, each of the one or more test tubes having an internal pressure less than atmospheric pressure, wherein each of the one or more test tubes is independently configured to include a preparation for urine analysis, a preparation for microbiological analysis, or not include an additive or preservative therein.

4. The urine sampling kit according to claim 1, wherein the preparation for urine analysis comprises chlorhexidine, ethyl paraben or sodium propionate, and the preparation for microbiological analysis comprises boric acid, sodium formate or sodium borate.

5. The urine sampling kit according to claim 1, further comprising a central supply chamber wrapper, wherein the central supply chamber wrapper is configured to maintain the sterility of the contents of the urine sampling kit while the central supply chamber wrapper is wrapped around the contents of the urine sampling kit. 6 . The urine sampling kit of claim 1 , further comprising a molded tray comprising one or more compartments configured to hold the contents of the urine sampling kit.

7. The urine sampling kit according to claim 1, further comprising an outer packaging of the urine sampling kit, wherein the outer packaging is configured to protect the urine sampling kit from damage and loss of components of the urine sampling kit from a point of manufacture of the urine sampling kit to a point of use of the urine sampling kit.

8. A catheterization and urine sampling kit comprising: A set of catheterization components, comprising a pre-connected catheter assembly, the pre-connected catheter assembly comprising a urinary catheter, drainage tubing, and a connector, the connector fluidly connecting the urinary catheter to the drainage tubing, the connector including a urine sampling port; and A complete set of urine sampling components, the complete set of urine sampling components comprising: a sampling port access device including a tip at one end of a barrel, the tip being configured to fluidly and exclusively connect the sampling port access device to a urine sampling port of a catheter assembly; Hand sanitizer packets; Pairs of sterile gloves; a sterilant-saturated material in a clean form packaged in a clean form configured for cleaning; and a drape for placement on a patient, the drape having perforations of a shape and size that allow dedicated access to the urethral sampling port of the catheter assembly when the drape is draped over the patient, The contents of the catheterization and urine sampling kit are packaged according to step-by-step instructions for sterile urine sampling, and the contents include the sampling port access device, the hand sanitizer package, the pair of sterile gloves, and the sterilant saturated material in a clean form package.

9. The catheterization and urine sampling kit of claim 8, wherein the drape comprises: a first drape for placement on a patient, the first drape having perforations of a shape and size that allow access to the patient for insertion of the urinary catheter when the first drape is draped over the patient; and A second drape is provided for placement on the patient, the perforations of the second drape being shaped and sized to allow access to the urine sampling port when the second drape is draped over the patient.

10. A method for sterile urine sampling, comprising: removing outer packaging from a urine sampling kit to expose one or more steps in a set of step-by-step instructions for urine sampling incorporated into the urine sampling kit; Aseptically opening the urine sampling kit to form a sterile working surface of the inner surface of the central supply chamber package for urine sampling, the opening exposing the additional steps of the step-by-step instructions and the sterile contents of the urine sampling kit disposed on the sterile working surface, the sterile contents comprising: a sampling port access device including a tip at one end of a barrel, the tip being configured to fluidly and exclusively connect the sampling port access device to a urine sampling port of a catheter assembly; a sterilant-saturated material in a clean form packaged in a clean form configured for cleaning; and a drape for placement on a patient, the drape having perforations of a shape and size that permit dedicated connection to the urethral sampling port of the catheter assembly when the drape is draped over the patient, cleaning the urine sampling port of the catheter assembly using the antiseptic-saturated material in the clean form; fluidly connecting the sampling port access device to the urine sampling port of the catheter assembly; and A urine sample is drawn from the urine sampling port of the catheter assembly.

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