Catheterization packages and methods thereof

Abstract

To provide catheterization packages.SOLUTION: A catheterization package 100 includes catheterization components. The catheterization components include a urinary catheter 130, a urine-drainage bag 140, a container containing a lubricant 190, and a catheterization tray 110. The catheterization tray includes: a first compartment 112 configured to hold the urinary catheter; a second compartment 114 configured to hold the urine-drainage bag; a catheter-lubrication compartment 120 configured to hold the container containing the lubricant; and step-by-step instructions for the catheterization procedure. The first compartment includes a first portion and a second portion positioned on opposite sides of the catheter lubrication compartment, and a third portion that connects the first portion and the second portion to each other.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a catheter treatment package and method. [Background technology]

[0002] Catheters suitable for draining a patient's bladder include indwelling catheters. Indwelling catheters include Foley catheters, which are typically indicated for surgical and medical patients who require at least temporary assistance with bladder drainage. Common indications include acute or chronic urinary retention, medical procedures that may at least temporarily restrict patient movement, the need for accurate monitoring of fluid input and urine output such as in intensive care units (ICUs), benign prostatic hyperplasia, incontinence, or the effects of various surgical interventions involving the bladder or prostate.

[0003] A standard Foley catheter design includes a balloon located at the distal end of the catheter to secure the catheter to the bladder. The catheter includes at least one lumen for draining urine from the bladder and at least one lumen for inflating the balloon (e.g., with sterile water). The proximal end of the Foley catheter includes at least two ports that communicate with the two lumens. The first port is connected to the drain lumen and interfaces with fittings for drainage and sampling. The second port is connected to the inflation lumen with a valve so that inflation fluid remains within the lumen and balloon when filled. The tip of a standard Foley catheter extends beyond the side of the balloon into the bladder and includes one or more openings or "eyelets" for draining fluid and debris from the bladder. Although catheters with various additions (e.g., mechanical anchors, etc.) and improvements have been proposed and studied, this standard design has remained unchanged for approximately 100 years.

[0004] Catheters suitable for draining a patient's bladder also include intermittent catheters. A typical intermittent catheter differs from an indwelling catheter primarily in that the intermittent catheter does not have a retention balloon or associated inflation lumen. Rather, an intermittent catheter is typically a single lumen device with multiple drainage eyelets at the distal end and a funnel at the proximal end. Intermittent catheterization is often performed in individuals whose urinary system is dysfunctional (e.g., those suffering from strictures or trauma) or who have disabilities that prevent them from urinating spontaneously (e.g., paraplegics or quadriplegics). Such individuals often self-catheterize with an intermittent catheter several times a day.

[0005] An intermittent catheter is generally a catheter or tube with a rounded, atraumatic distal tip that is inserted into the patient's bladder. A shaped funnel is usually connected to the proximal end that remains outside the patient's or user's body. The distal tip may include a slot or opening in the shaft to facilitate the drainage of urine therefrom once the tip is positioned inside the bladder.

[0006] Non-limiting suitable examples of urinary catheters, trays, insertion devices, and the like can be found, for example, in US Pat. Nos. 5,943,393; 5,943,621; and 5,943,633, which are incorporated herein by reference in their entireties. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 8,328,792 [Patent Document 2] U.S. Patent No. 8,998,882 [Patent Document 3] US Patent Application Publication No. 2016 / 0228676 [Patent Document 4] US Patent Application Publication No. 2017 / 0216558 Summary of the Invention [Problem to be solved by the invention]

[0008] Research suggests 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. Nursing decision makers believe that such variability and improper urine sampling technique increases the risk of contamination and leads to false-positive catheter-associated urinary tract infections (CAUTIs). Not only do up to 70% of urine cultures reflect false-positive results that lead to inaccurate CAUTI diagnoses and inappropriate antibiotic treatment, but they also artificially undermine the time and resources hospitals are devoting to reducing the risk of CAUTI by other means. This issue presents an ongoing challenge to those seeking to lower CAUTI rates.

[0009] Disclosed herein are catheterization packages and methods for facilitating catheterization and urine sampling in an effort to reduce CAUTI and false positive results that lead to inaccurate CAUTI diagnoses. [Means for solving the problem]

[0010] Disclosed herein, in some embodiments, is a catheterization package including a catheterization package component and a catheterization tray configured to facilitate a catheterization procedure. The catheterization package component includes a urinary catheter, a urine drainage bag fluidly connected to the urinary catheter, and a sampling port access device. The sampling port access device is configured to fluidly connect to a urine sampling port of the urinary catheter or a urine drainage bag for aseptic collection of one or more urine samples. The catheterization tray includes several compartments configured to hold the catheterization package components. A first compartment of the catheterization tray is configured to hold a urinary catheter. A second compartment of the catheterization tray is connected to the first compartment by an inter-compartment connection. The second compartment is configured to hold a urine drainage bag. A third compartment of the catheterization tray is configured to hold a sampling port access device. Step-by-step instructions for facilitating a catheterization procedure are incorporated into the catheterization tray.

[0011] In some embodiments, the urine drainage bag includes an inlet port and an outlet port. The outlet port includes a urine sampling port incorporated therein for sterile collection of one or more urine samples with a sampling port access device.

[0012] In some embodiments, the sampling port access device includes a barrel, a tip at the end of the barrel, and a hollow needle coaxial with the barrel. The tip of the barrel is configured to fluidly connect the sampling port access device to a urine sampling port of a urinary catheter or a urine drainage bag. The needle is fluidly connected to the tip of the barrel, but the tip of the needle is pointed away from the tip of the barrel.

[0013] In some embodiments, the catheterization component further includes one or more septum-stoppered test tubes configured for use with the sampling port access device, each test tube in the one or more test tubes having an internal pressure less than atmospheric pressure, and each test tube is independently configured to contain a formulation for urinalysis, a formulation for microbiological analysis, or to contain no additives or preservatives.

[0014] In some embodiments, the catheter procedure component further includes one or more swabs, a package of antiseptic skin cleanser, or a package of one or more swabs in an antiseptic skin cleanser.

[0015] In some embodiments, the catheter procedure tray further includes a separated fourth compartment configured to hold one or more swabs, a package of antiseptic skin cleanser, or a package of one or more swabs in an antiseptic skin cleanser.

[0016] In some embodiments, the fourth compartment includes a well and one or more channels with snap-in tabs configured to hold one or more swabs therein, respectively, the one or more channels being angled relative to the top or bottom of the catheterization tray such that one or more swab heads of the one or more swabs are disposed within the well, respectively, when snapped into the one or more channels.

[0017] In some embodiments, the catheter procedure component further includes a container containing a lubricant configured to lubricate the urinary catheter following a catheter procedure. In some embodiments, the catheter procedure tray further includes a fifth compartment at least partially surrounded by the first compartment, the fifth compartment configured to hold a container containing a lubricant, the fifth compartment also configured to hold a lubricant dispensed therefrom.

[0018] In some embodiments, the catheterization component further includes a specimen container configured for at least clean collection of one or more urine samples from the urine drainage bag.

[0019] In some embodiments, the catheter procedure tray further includes a fifth compartment at least partially surrounded by the first compartment, the fifth compartment configured to hold a specimen container.

[0020] In some embodiments, the catheter procedure components further include a set of exam gloves and an underpad. In some embodiments, the catheterization package further includes a packaging for the catheterization package. The packaging includes a sheet of paper or paperboard, a central supply laboratory (CSR) wrap, and an outer packaging for the catheterization package. The sheet of paper or paperboard is configured to cover the catheterization tray and the catheterization components therein. The central supply laboratory (CSR) wrap is configured to be wrapped around the catheterization tray and the catheterization components therein to maintain sterility of the contents of the catheterization package. The outer packaging is configured to prevent loss of the contents of the catheterization package from the time the catheterization package is assembled to the time the catheterization package is used. The outer packaging is also configured to prevent contamination of the contents of the catheterization package from the time of ethylene oxide sterilization of the catheterization package to the time the catheterization package is used.

[0021] Disclosed herein, in some embodiments, is a catheterization package including a catheterization package component configured to facilitate catheterization and a molded catheterization tray. The catheterization package component includes a urinary catheter, a urine drainage bag fluidly connected to the urinary catheter, a sampling port access device configured to fluidly connect to a urine sampling port integrated into the outlet port of the urine drainage bag for aseptic collection of one or more urine samples, one or more swabs configured for use with an antiseptic skin cleanser, and a container including a lubricant configured to lubricate the urinary catheter. The catheterization tray includes several compartments configured to hold the catheterization package components. The urinary catheter compartment of the catheterization tray is configured to hold a urinary catheter. The urine drainage bag compartment of the catheterization tray is connected to the urinary catheter compartment by an inter-compartment connection. The urine drainage bag compartment is configured to hold a urine drainage bag. The sampling port access device compartment of the catheterization tray is configured to hold a sampling port access device. The isolated skin cleaning compartment is configured to hold one or more swabs. The catheter lubrication compartment is substantially surrounded by the urinary catheter compartment. The catheter lubrication compartment is configured to hold a container containing a lubricant. The catheter lubrication compartment is also configured to hold lubricant dispensed from the container containing the lubricant. Step-by-step instructions for facilitating the catheterization procedure are embossed on the catheterization tray, printed on the catheterization tray, or embossed and printed on the catheterization tray. At least some of the step-by-step instructions for the catheterization procedure are apparent when the catheterization package components are removed from the catheterization tray.

[0022] Disclosed herein is a method for manufacturing a catheterization package, the method including molding a catheterization tray configured to facilitate a catheterization procedure, incorporating step-by-step instructions for the catheterization procedure into the catheterization tray, and disposing catheterization package components in the catheterization tray. The molding includes molding a urinary catheter compartment, molding a urinary drainage bag compartment connected to the urinary catheter compartment by an inter-compartment connection, and molding a sampling port access device compartment. Disposing the catheterization package components in the catheterization tray includes disposing a urinary catheter in the urinary catheter compartment, disposing a urinary drainage bag in the urinary drainage bag compartment, and disposing a sampling port access device in the sampling port access device compartment, the sampling port access device configured to fluidly connect to a urine sampling port of the urinary catheter or a urine drainage bag for sterile collection of one or more urine samples. The urinary drainage bag is fluidly connected to the urinary catheter such that when the urinary catheter and the urinary drainage bag are placed in the urinary catheter compartment and the urinary drainage bag compartment, respectively, the urinary catheter is positioned across the inter-compartment connection.

[0023] In some embodiments, placing the catheter procedure package components on the catheter procedure tray further includes placing one or more septum stoppered test tubes configured for use with a sampling port access device either above or below the urine drainage bag in the urine drainage bag compartment.

[0024] In some embodiments, molding the catheter procedure tray further comprises molding a separated skin cleaning compartment. Placing the catheter procedure package components in the catheter procedure tray further includes placing one or more swabs in the skin cleaning compartment, placing a package of antiseptic skin cleanser in the skin cleaning compartment, or placing a package of one or more swabs in antiseptic skin cleanser in the skin cleaning compartment.

[0025] In some embodiments, molding the catheter procedure tray further comprises molding a catheter lubrication compartment at least partially surrounded by the urinary catheter compartment.

[0026] In some embodiments, placing the catheter procedure package components in the catheter procedure tray includes placing a container containing a lubricant in the catheter lubrication compartment.

[0027] In some embodiments, placing the catheter procedure package components on the catheter procedure tray further includes placing a set of examination gloves in or on one or more compartments of the catheter procedure tray and folding an underpad and placing the underpad over the set of examination gloves.

[0028] In some embodiments, the method further includes placing a sheet of paper or paperboard over the catheterization tray containing the catheterization components to form a paper or paperboard covered catheterization tray, wrapping the paper or paperboard covered catheterization tray in a CSR wrap to form a CSR-wrapped catheterization tray, placing the CSR-wrapped catheterization tray in an outer packaging to form a catheterization package, and sterilizing the catheterization package by ethylene oxide sterilization.

[0029] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and following description, which disclose in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0030] [Figure 1] 1 illustrates at least a portion of a first catheter procedure package, according to some embodiments. [Diagram 2] FIG. 1 illustrates some catheter procedure components removed from a catheter procedure tray of a first catheter procedure package, according to some embodiments. [Diagram 3] 1 illustrates at least a portion of a second catheter procedure package, according to some embodiments. [Figure 4] FIG. 13 illustrates some catheter procedure components removed from a catheter procedure tray of a second catheter procedure package, according to some embodiments. [Diagram 5] 1 illustrates at least a portion of a urine drainage bag, according to some embodiments. [Figure 6] FIG. 13 illustrates an exploded view of a third catheter procedure package, according to some embodiments. [Figure 7] 13A-13C illustrate at least a portion of a third catheter procedure package, according to some embodiments. [Figure 8] 13A-13C illustrate at least a portion of a fourth catheter procedure package, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Before some specific embodiments are disclosed 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 can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other several embodiments disclosed herein.

[0032] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain embodiments, and that the 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 within a group of features or steps, and do not provide serial 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," "upper," "lower," "front," and "rear" are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0033] With respect to "proximal," "proximal portion," or "proximal end portion," for example, the catheters disclosed herein include 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 portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of the catheter.

[0034] With respect to "distal," "distal portion," or "distal end portion," for example, the catheters disclosed herein include the portion of the catheter that is intended to be near or within the 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 the 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 the patient when the catheter is used with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0035] 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. Disclosed herein are catheterization packages and methods for facilitating catheterization and urine sampling in an effort to reduce CAUTI and false positive results that lead to inaccurate CAUTI diagnoses.

[0036] Catheterization Package FIG. 1 illustrates at least a portion of a first catheter procedure package 100, according to some embodiments. FIG. 2 illustrates some catheter procedure components removed from a catheter procedure tray 110 of the first catheter procedure package 100, according to some embodiments. FIG. 3 illustrates at least a portion of a second catheter procedure package 300, according to some embodiments. FIG. 4 illustrates some catheter procedure components removed from a catheter procedure tray 310 of the second catheter procedure package 300, according to some embodiments. FIG. 6 illustrates an exploded view of a third catheter procedure package 600, according to some embodiments. FIG. 7 illustrates at least a portion of a third catheter procedure package 600, according to some embodiments. FIG. 8 illustrates at least a portion of a fourth catheter procedure package 800, according to some embodiments.

[0037] As shown, the catheterization package 100, 300, 600, or 800 includes a catheterization tray 110, 310, 610, or 810 and catheterization components described below, both of which are configured to facilitate a catheterization procedure. The catheterization package 100, 300, 600, or 800 is configured to facilitate a catheterization procedure by the catheterization components included in the catheterization package 100, 300, 600, or 800, by how the catheterization components are arranged in the catheterization tray 110, 310, and by the step-by-step instructions incorporated in the catheterization tray 110, 310, 610, or 810.

[0038] Starting with the catheterization tray 110, 310, 610, or 810, the catheterization tray 110, 310, 610, or 810 includes several compartments configured to hold catheterization components, as described below.

[0039] The urinary catheter compartment 112 of the catheterization tray 110, 310, 610, or 810 is configured to hold a urinary catheter. The urine drainage bag compartment 114 of the catheterization tray 110, 310, 610, or 810 is connected to the urinary catheter compartment 112 by an inter-compartment connection 113. The urine drainage bag compartment 114 is configured to hold at least a urine drainage bag.

[0040] The sampling port access device compartment 116 of the catheterization tray 110 or 310 is configured to hold a sampling port access device. Alternatively, the sampling port access device compartment 116 of the catheterization tray 310 is a catheter lubrication compartment 320 configured to hold a container containing a lubricant. The catheterization tray 610 or 810 includes a catheter lubrication compartment 620 or 820 configured to hold a container containing a lubricant instead of a separate sampling port access device compartment. Also, the catheter lubrication compartment 320, 620, or 820 is configured to hold lubricant dispensed from a container containing the lubricant in a well 322, 622, or 822 shared with the urinary catheter compartment 112. Because some embodiments of the catheterization tray 310, 610, or 810 do not have a sampling port access device compartment, when a sampling port access device is included in the catheterization package 300, 600, and 800, the urine drainage bag compartment 114 also functions as a sampling port access device compartment for the catheterization tray 310, 610, or 810.

[0041] The skin cleaning compartment 118 of the catheterization tray 110, 310, 610, or 810 is isolated from other compartments of the catheterization tray 110, 310, 610, or 810, which may be important in maintaining a sterile field around at least the urinary catheter compartment 112. The skin cleaning compartment 118 is configured to hold one or more swabs configured for skin cleaning with an antiseptic skin cleanser, a package of antiseptic skin cleanser, or a package of one or more swabs in an antiseptic skin cleanser. The skin cleaning compartment 118 includes a well 117 and one or more channels 119 with snap-in tabs 121 configured to hold one or more swabs therein, respectively. The one or more channels 119 are angled relative to the top or bottom of the catheterization tray 110, 310, 610, or 810 such that when the one or more stick members of each of the one or more swabs are snapped into the one or more channels 119, the one or more swab heads of the one or more swabs are disposed within the well 117, respectively. The one or more stick members are angled upward when snapped into the one or more channels 119 such that the one or more stick members can be grasped and removed from the one or more channels 119, respectively. The well 117 is configured to hold an antiseptic skin cleanser therein. When the one or more swab heads are disposed within the well 117 containing the antiseptic skin cleanser, the antiseptic skin cleanser soaks the one or more swab heads for antiseptic skin cleaning by each of the one or more swabs.

[0042] The catheter lubrication compartment 120 of the catheter procedure tray 110 is at least partially or substantially surrounded by the urinary catheter compartment 112. The catheter lubrication compartment 120 is configured to hold a container containing a lubricant and to hold lubricant dispensed from the container containing the lubricant in a well 122 shared with the urinary catheter compartment 112.

[0043] The specimen container compartment 324 of the catheterization tray 310, 610, or 810 is also at least partially or substantially surrounded by the urinary catheter compartment 112. The specimen container compartment 324 is configured to hold a specimen container. Due to the specimen container compartment 324 in the catheterization tray 310, 610, or 810, the urinary catheter compartment 112 also functions as a catheter lubrication compartment of the catheterization tray 310, 610, or 810, which includes a well 322, 622, or 822 configured to hold a lubricant. However, the well 322, 622, or 822 is reduced in size compared to the well 122 of the catheterization tray 110.

[0044] As best shown in Figures 2, 4, and 8, the step-by-step instructions incorporated into the catheterization tray 110, 310, 610, or 810 for a catheterization procedure may be incorporated into any compartment of the catheterization tray 110, 310, 610, or 810, any adjacent compartment of the catheterization tray 110, 310, 610, or 810, or a combination thereof. For example, a first instruction in the step-by-step instructions is directed to opening a container or package of an antiseptic skin cleanser, such as a povidone-iodine solution, and the first instruction is incorporated into the catheterization tray 110, 310, 610, or 810 adjacent to the skin cleansing compartment 118. A second instruction in the step-by-step instructions is directed to pouring the skin cleanser into the well 117 of the skin cleansing compartment 118, and the second instruction is incorporated into the skin cleansing compartment 118. A third instruction in the instructions is directed to dispensing lubricant into well 122, 322, 622, or 822, which is incorporated adjacent to well 122 of catheter lubrication compartment 120 of catheter procedure tray 110, well 322 or 622 of urinary catheter compartment 112 of catheter procedure tray 310 or 610, or well 822 of urinary catheter compartment 112 of catheter procedure tray 810. A fourth instruction in the instructions is directed to retracting the patient's genitals, a fifth instruction in the instructions is directed to preparing the patient with a cotton swab soaked with an antiseptic skin cleanser, and a sixth instruction in the instructions is directed to inserting a urinary catheter into the patient. The fourth, fifth, and sixth instructions in the step-by-step instructions are incorporated into the urinary drainage bag compartment 114 of the catheterization tray 110, 310, or 610. However, due to the relatively small size of the urinary drainage bag compartment 114 of the catheterization tray 810, the fourth, fifth, and sixth instructions in the step-by-step instructions are incorporated between the skin cleansing compartment 118 and the catheter lubrication compartment 820 of the catheterization tray 810 for increased visibility.

[0045] As shown in Figures 1 and 2 or 3 and 4, at least some of the step-by-step instructions for the catheterization procedure become apparent when the catheterization components are removed from the catheterization tray 110 or 310. Also, although not shown, at least some of the step-by-step instructions for the catheterization procedure become apparent when the catheterization components are removed from the catheterization tray 610 or 810. Revealing the instructions for the catheterization procedure in this manner reduces the instructional information to information that is immediately or immediately needed, thereby reducing the possibility of information overload and simplifying the catheterization procedure.

[0046] The catheterization trays 110, 310, 610, and 810 in Figures 1-4, 6, 7, and 8 are specific to some catheterization package embodiments, and other embodiments may include different combinations of compartments configured to hold different combinations of catheterization components, fewer compartments configured to hold fewer catheterization components, or more compartments configured to hold more catheterization components. For example, a catheterization tray with more compartments than the catheterization tray 310 may include all three of the sampling port access device compartment 116, the catheter lubrication compartment 320, and the specimen container compartment 324. Such a configuration may include the catheterization tray 310 with the catheter lubrication compartment 320 and the urinary bag compartment 114 shown in Figure 3, with an additional compartment (not shown) corresponding to the sampling port access device compartment 116 between the catheter lubrication compartment 320 and the urinary bag compartment 114.

[0047] The catheterization tray 110, 310, 610, or 810 can be formed, for example, by injection molding, whereby each compartment is simultaneously formed in the catheterization tray 110, 310, 610, or 810. However, the catheterization tray 110, 310, 610, or 810 is not limited to being formed by injection molding or by molding. If molding is used to form the catheterization tray 110, 310, 610, or 810, the step-by-step instructions may also be simultaneously formed in or on the catheterization tray 110, 310, 610, or 810 as embossed step-by-step instructions. To improve the contrast of the step-by-step instructions on the catheter procedure tray 110, 310, 610, or 810, the step-by-step instructions may be printed on the catheter procedure tray 110, 310, 610, or 810 in the absence of embossed step-by-step instructions or over the embossed step-by-step instructions.

[0048] With respect to the catheterization components of which the catheterization tray 110, 310, 610, or 610 is comprised, the catheterization components may include, but are not limited to, a urinary catheter 130, a urinary drainage bag 140 or 640, a sampling port access device 150, one or more septum stoppered test tubes 160, a specimen container 170, one or more swabs 180, a container containing a lubricant 190, or combinations thereof, as described below.

[0049] The urinary catheter 130 may be an indwelling catheter, such as a Foley catheter, as shown, or an intermittent catheter, each of which are described above. The urinary catheter 130 is optionally already fluidly connected to a urinary drainage bag 140 or 640 in the catheterization package 100, 300, 600, or 800, which simplifies the catheterization procedure and reduces the risk of inadvertently contaminating the urinary catheter 130, such as by connecting the urinary catheter 130 to the urinary drainage bag 140 or 640.

[0050] 5 illustrates at least a portion of a urine drainage bag 140, according to some embodiments. The urine drainage bag 140 includes an inlet port 142 and an outlet port 144. The outlet port 144 includes a urine sampling port 146 incorporated therein for aseptically collecting one or more urine samples with a sampling port access device 150. As also shown in FIG. 5, the urine drainage bag 140 includes an optional channel 148 configured to receive an intermittent catheter, such as the urinary catheter 130, following their use for disposal of the intermittent catheter along with the urine drainage bag 140.

[0051] The urination bag 640 differs from the urination bag 140 at least with respect to the placement of the urine sampling port, which is incorporated into the inlet port of the urination bag 640 instead of the outlet port of the urination bag 140. Additionally, a tubing clamp 642 is coupled to the urination bag 640 such that the tubing clamp 642 is configured to clamp the inlet port between the urine sampling port and the bag portion of the urination bag 640, thereby preventing urine already present in the urination bag 640 from being sampled through the urine sampling port. Such a configuration of the urination bag 640 ensures that the urine sample from the urine sampling port is fresh from the urinary catheter 130.

[0052] The sampling port access device 150 is configured to fluidly connect to a urine sampling port of a urinary catheter 130 (e.g., a urine sampling port of a Foley catheter) or a urine sampling port 146 of a urine drainage bag 140 for the sterile collection of one or more urine samples. The sampling port access device 150 includes a barrel 152, a tip 154 ​​at the end of the barrel 152, and a hollow needle 156 coaxial with the barrel 152. The tip 154 ​​of the barrel 152 is configured to fluidly connect the sampling port access device 150 to the urine sampling port of a urinary catheter or the urine sampling port 146 of a urine drainage bag 140 (see FIG. 3 for the sampling port access device 150 fluidly connected to the urine sampling port 146 of a urine drainage bag 140). The needle 156 is fluidly connected to the tip 154 ​​of the barrel 152, but the tip of the needle 156 is directed away from the tip 154 ​​of the barrel 152.

[0053] The one or more septum-stoppered test tubes 160 are configured for use with the sampling port access device 150. Each of the one or more test tubes 160 has an internal pressure less than atmospheric pressure such that urine is aspirated into the test tube from the urine sampling port of the urinary catheter 130 or the urine sampling port 146 of the urinary drainage bag 140 when certain conditions are met. For example, urine is aspirated into the test tube when the urinary drainage bag 140 is at least partially filled with urine, the tip 154 ​​of the sampling port access device 150 is fluidly connected to the urine sampling port 146 of the urinary drainage bag 140, and the septum stopper of the test tube is punctured by the needle 156 of the sampling port access device 150. Each test tube is independently configured to contain a preparation for urinalysis, a preparation for microbiological analysis, or to contain no additives or preservatives.

[0054] The specimen container 170 is configured for at least clean collection of one or more urine samples from the urination bag 140 or 640, such as via the exit port 144 of the urination bag 140, thereby providing an alternative means for sterile collection of one or more urine samples as desired. As shown at least in FIG. 6, the specimen container 170 includes a cap 172 configured to seal the urine sample within the specimen container 170. A label 174 is optionally included in the catheterization package 100, 300, 600, or 800 for labeling the specimen container 170 according to any urine sample therein. The clean collection of one or more urine samples utilizes the exit port 144 of the urination bag 140 and the specimen container 170 to reduce transfer of microorganisms from the healthcare worker and the environment to the one or more urine samples. However, to reduce as well as prevent the transfer of microorganisms from healthcare personnel and the environment into the urine sample(s), sterile collection of the urine sample(s) requires the use of a sampling port on the urinary catheter or a sampling port 146 on the urine drainage bag 140, a sampling port access device 150, and one or more test tubes 160.

[0055] The one or more swabs 180 are configured for skin cleaning with an antiseptic skin cleanser. The one or more swabs 180 are optionally already snapped into one or more channels 119 of the skin cleansing compartment 118 by the respective one or more stick members in the catheterization package 100, 300, 600, or 800. As shown only in Figs. 6 and 7, the catheterization package 100, 300, 600, or 800 can include a package of antiseptic skin cleanser 182, which can be, for example, a povidone-iodine solution for pouring into the well 117 of the skin cleansing compartment 118 to soak one or more swab heads of the one or more swabs 180, respectively, for skin cleaning. Alternatively, the one or more swabs 180 are packaged in the package of antiseptic skin cleanser 182.

[0056] The container containing the lubricant 190 may be a syringe of lubricating jelly configured to facilitate lubrication of the urinary catheter 130 in the well 122 of the catheter lubrication compartment 120 of the catheter procedure tray 110 or the well 322, 622, or 822 of the urinary catheter compartment 112 of the catheter procedure tray 310, 610, or 810 following a catheter procedure.

[0057] Although not shown, the catheterization components of the catheterization tray 110, 310, 610, or 810 may further include, but are not limited to, one or more pairs of exam gloves and an underpad. The one or more pairs of gloves and the underpad are configured for use during a catheterization procedure, such as during skin cleaning with an antiseptic skin cleanser, during lubrication of the urinary catheter 130 with a lubricant in a container containing the lubricant 190, and during insertion of the urinary catheter 130 into a patient. The one or more pairs of gloves may be positioned in or on any compartment of the catheterization tray 110, 310, 610, or 810. The underpad may be folded and placed under one or more pairs of gloves, between one or more pairs of gloves, or on top of one or more pairs of gloves.

[0058] Although not shown, the catheterization package 100, 300, 600, or 800 further includes packaging for the catheterization package 100, 300, 600, or 800. The packaging includes a sheet of paper or paperboard, a CSR wrap, and an outer packaging for the catheterization package 100, 300, 600, or 800.

[0059] The sheet of paper or paperboard is configured to cover the catheterization tray 110, 310, 610, or 810 and the catheterization components therein. Figures 1-4, 6, and 7 show a lip around the catheterization tray 110, 310, 610, or 810 onto which the sheet of paper or paperboard is configured to be placed. Optionally, the paper or paperboard includes additional instructions to the product information or step-by-step instructions printed thereon.

[0060] The CSR wrap is configured to maintain the sterility of at least the catheterization components of the catheterization package 100, 300, 600, or 800 while the CSR wrap is wrapped around the catheterization tray 110, 310, 610, or 810 and the catheterization components therein.

[0061] The outer packaging is configured to prevent loss of the contents of the catheter procedure package 100, 300, 600, or 800 from the time the catheter procedure package 100, 300, 600, or 800 is assembled to the time the catheter procedure package 100, 300, 600, or 800 is used. The outer packaging is also configured to prevent contamination of the contents of the catheter procedure package 100, 300, 600, or 800 from the time ethylene oxide sterilization of the catheter procedure package 100, 300, 600, or 800 to the time the catheter procedure package 100, 300, 600, or 800 is used.

[0062] method A method for manufacturing the catheterization package 100, 300, 600, or 800 includes molding the catheterization tray 110, 310, 610, or 810, incorporating step-by-step instructions for a catheterization procedure into the catheterization tray 110, 310, 610, or 810, and disposing catheterization components on the catheterization tray 110, 310, 610, or 810. The molding includes molding the urinary catheter compartment 112, molding the urine drainage bag compartment 114 connected to the urinary catheter compartment 112 by an inter-compartment connection 113, and for at least some embodiments of the catheterization tray 110 and the catheterization tray 310, molding the sampling port access device compartment 116. Placing the catheterization components in the catheterization tray 110, 310, 610, or 810 includes placing the urinary catheter 130 in the urinary catheter compartment 112, placing the urinary drainage bag 140 in the urinary bag compartment 114, and placing the sampling port access device 150 in the sampling port access device compartment 116 if such a compartment is present. Otherwise, the sampling port access device 150 may be placed in the urinary bag compartment 114, if desired. The urinary catheter 130 is fluidly connected to the urinary drainage bag 140 such that the urinary catheter 130 is positioned across the inter-compartment connection 113 when placing the urinary catheter 130 and the urinary drainage bag 140 in the urinary catheter compartment 112 and the urinary bag compartment 114, respectively.

[0063] Placing the catheterization components in the catheterization tray 110, 310, 610, or 810 may further include placing one or more septum-stoppered test tubes 160 for use with the sampling port access device 150 in the urine bag compartment 114, either above or below the urine bag 140.

[0064] Molding the catheter procedure tray 110, 310, 610, or 810 may further include molding a separated skin cleansing compartment 118. Placing the catheterization components in the catheterization tray 110, 310, 610, or 810 may further include placing one or more swabs 180 in the skin cleaning compartment 118, placing a package of antiseptic skin cleanser 182 in the skin cleaning compartment 118, or placing a package of one or more swabs 180 in antiseptic skin cleanser in the skin cleaning compartment 118.

[0065] Molding the catheter procedure tray 110, 310, 610, or 810 may further include molding a catheter lubrication compartment 120 at least partially surrounded by a catheter lubrication compartment 320, 620, or 820 between the urinary catheter compartment 112 or the skin cleansing compartment 118 and the urinary bag compartment 114.

[0066] Placing the catheter procedure components in the catheter procedure tray 110, 310, 610, or 810 may further include placing a container containing lubricant 190 in the catheter lubrication compartment 120, 320, 620, or 820.

[0067] Placing the catheter procedure components on the catheter procedure tray 110, 310, 610, or 810 may include placing one or more pairs of examination gloves in or on a compartment of the catheter procedure tray 110, 310, 610, or 810, and folding an underpad and placing the underpad over the one or more pairs of examination gloves.

[0068] The method may further include placing a sheet of paper or paperboard on the catheterization tray 110, 310, 610, or 810 containing the catheterization components to form a paper or paperboard covered catheterization tray, wrapping the paper or paperboard covered catheterization tray in a CSR wrap to form a CSR-wrapped catheterization tray, placing the CSR-wrapped catheterization tray in an outer packaging to form a catheterization package, and sterilizing the catheterization package 100, 300, or 600 by ethylene oxide sterilization.

[0069] 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 understood by those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter procedure package comprising a catheter procedure component, the catheter procedure component comprising: A urinary catheter, a urine drainage bag fluidly connected to the urinary catheter; a container containing a lubricant configured to lubricate the urinary catheter following a catheterization procedure; and a catheter procedure tray configured to facilitate catheterization, the catheter procedure tray comprising: a first compartment configured to hold the urinary catheter; a second compartment connected to the first compartment by an inter-compartment connection and configured to hold the urine drainage bag; a catheter lubrication compartment configured to hold the container containing the lubricant and the lubricant dispensed from the container, the catheter lubrication compartment being at least partially surrounded by the first compartment; and step-by-step instructions for a catheterization procedure incorporated into the catheterization tray; The first compartment comprises: a first portion and a second portion positioned on opposite sides of the catheter lubrication compartment; a third portion connecting the first portion and the second portion to each other; A catheter treatment package comprising:

2. The catheter procedure package of claim 1 , wherein the third portion of the first compartment is connected to the inter-compartment connection via the first portion or the second portion.

3. 1. A method for manufacturing a catheter procedure package, comprising: forming a catheterization tray configured to facilitate catheterization; incorporating step-by-step instructions for a catheterization procedure into said catheterization tray; placing catheter procedure components on the catheter procedure tray; Equipped with Molding the catheter procedure tray comprises: forming a urinary catheter compartment; forming a urinary drainage bag compartment connected to said urinary catheter compartment by an inter-compartment connection; molding a catheter lubrication compartment configured to hold a container containing a lubricant and configured to hold lubricant dispensed from the container, the catheter lubrication compartment being at least partially surrounded by the urinary catheter compartment; Equipped with The urinary catheter compartment comprises: a first portion and a second portion positioned on opposite sides of the catheter lubrication compartment; a third portion connecting the first portion and the second portion to each other; Equipped with Placing the catheter procedure components on the catheter procedure tray comprises: placing a urinary catheter in the urinary catheter compartment; placing a urinary drainage bag in the urinary bag compartment, the urinary drainage bag being fluidly connected to the urinary catheter such that placing the urinary catheter and the urinary drainage bag in the urinary catheter compartment and the urinary drainage bag compartment, respectively, includes placing the urinary catheter across the inter-compartment connection; placing the container containing the lubricant in the catheter lubrication compartment; A method comprising:

4. The method of claim 3 , wherein the third portion of the urinary catheter compartment is connected to the inter-compartment connection via the first portion or the second portion.

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