Catheter treatment package and method

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] This invention relates to a catheter treatment package and method thereof.

Background Art

[0002] Catheters suitable for draining a patient's bladder include indwelling catheters. Indwelling catheters include Foley catheters, which are typically adapted for surgical and medical patients who at least temporarily require assistance with bladder voiding. Common applications 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 in an intensive care unit (ICU), benign prostatic hyperplasia, incontinence, or the effects of various surgical interventions including the bladder or prostate.

[0003] The standard Foley catheter design includes a balloon disposed at the distal end of the catheter to secure the catheter in 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 drainage lumen and has an interface with a fitting for drainage and sampling. The second port is connected to the inflation lumen with a valve such that when the inflation fluid is filled, the inflation fluid remains within the lumen and the balloon. The tip of the standard Foley catheter extends into the bladder beyond the side of the balloon and includes one or more openings, i.e., "eyelets," for draining fluid and debris from the bladder. Although catheters with various additional (e.g., mechanical anchors, etc.) and improved designs have been proposed and studied, this standard design has not changed 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 it does not have a retaining balloon or associated inflation lumen. Rather, an intermittent catheter is typically a single-lumen device with multiple drainage holes at the distal end and a funnel at the proximal end. Intermittent catheterization is commonly used for people with urinary tract dysfunction (e.g., those suffering from strictures or trauma) or those with disabilities that prevent them from urinating spontaneously (e.g., paraplegia or quadriplegia). Such individuals often self-catheterize several times a day with an intermittent catheter.

[0005] An intermittent catheter is generally a catheter or tube with a rounded, non-traumatic distal end that is inserted into a patient's bladder. The molded funnel is usually connected to a proximal end that remains outside the patient's or user's body. The distal end may include a slot or opening in the shaft to facilitate the drainage of urine after the end has been positioned inside the bladder.

[0006] Non-limiting suitable examples of urethral catheters, trays, insertion devices, etc., can be found, for example, in Patent Documents 1-4, which are incorporated herein by reference in their entirety. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 8328792 [Patent Document 2] U.S. Patent No. 8998882 [Patent Document 3] U.S. Patent Application Publication No. 2016 / 0228676 [Patent Document 4] U.S. Patent Application Publication No. 2017 / 0216558 [Overview of the project] [Problems that the invention aims to solve]

[0008] Studies suggest that there is variability in all aspects of urine sampling, including where urine samples are collected from the collection system, how urine sampling areas are cleaned, the devices used to collect urine samples, and how urine samples are transported to the laboratory. Nursing decision-makers believe that such variability and inadequate urine sampling techniques increase the risk of contamination and lead to false-positive catheter-related urinary tract infections (CAUTIs). Up to 70% of urine cultures not only reflect false-positive results that lead to inaccurate CAUTI diagnoses and inappropriate antibiotic treatment, but also artificially undermine the time and resources that hospitals are spending to reduce the risk of CAUTI through other means. This issue presents an ongoing challenge for those trying to lower CAUTI rates.

[0009] This specification discloses a catheterization package and method for facilitating catheterization and urine sampling in efforts to reduce CAUTI and false positive results that lead to inaccurate CAUTI diagnoses. [Means for solving the problem]

[0010] Disclosed herein are catheterization packages, including, in some embodiments, catheterization package components and a catheterization tray configured to facilitate catheterization. The catheterization package components include a urethral catheter, a urination bag fluidly connected to the urethral catheter, and a sampling port access device. The sampling port access device is configured to fluidly connect to the urine sampling port of the urethral catheter or to the urination bag for sterile 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 the urethral 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 the urination bag. A third compartment of the catheterization tray is configured to hold the sampling port access device. Step-by-step instructions for facilitating catheterization are incorporated into the catheterization tray.

[0011] In some embodiments, the urination 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 using 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 or urination bag of a urethral catheter. The needle is fluidly connected to the tip of the barrel, but the tip of the needle is directed away from the tip of the barrel.

[0013] In some embodiments, the catheterization component further includes one or more test tubes with septum stoppers configured for use with a sampling port access device. Each test tube in the one or more test tubes has an internal pressure lower than atmospheric pressure. Each test tube is independently configured to contain a preparation for urinalysis, a preparation for microbiological analysis, or to be free of additives and preservatives.

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

[0015] In some embodiments, the catheter treatment tray further includes an isolated fourth compartment. The fourth compartment is configured to hold one or more cotton swabs, a package of antiseptic skin wash, or a package of one or more cotton swabs in an antiseptic skin wash.

[0016] In some embodiments, the fourth compartment includes a well and one or more channels, each having a snap-in tab configured to hold one or more swabs therein. The one or more channels are angled with respect to the top or bottom of the catheter treatment tray such that when snapped into the one or more channels, one or more swab heads of the one or more swabs are positioned within the well.

[0017] In some embodiments, the catheterization component further includes a container containing a lubricant configured to lubricate a urethral catheter in accordance with the catheterization procedure. In some embodiments, the catheter treatment tray further includes a fifth compartment at least partially enclosed by the first compartment. The fifth compartment is configured to hold a container containing a lubricant. The fifth compartment is also configured to hold the 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 a urination bag.

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

[0020] In some embodiments, the catheter treatment component further includes a pair of examination gloves and an underpad. In some embodiments, the catheterization package further includes packaging for the catheterization package. The packaging includes a sheet of paper or cardboard, a central sterile supply (CSR) wrap, and outer packaging for the catheterization package. The sheet of paper or cardboard is configured to cover the catheterization tray and the catheterization components within it. The central sterile supply (CSR) wrap is configured to wrap around the catheterization tray and the catheterization components within it to maintain the 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 until 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 the catheterization package is sterilized with ethylene oxide until the time the catheterization package is used.

[0021] Disclosed herein are catheterization packages, in some embodiments, comprising a catheterization package component and a molded catheterization tray configured to facilitate catheterization. The catheterization package component includes a urethral catheter, a urination bag fluidly connected to the urethral catheter, a sampling port access device fluidly connected to a urine sampling port incorporated into the outlet port of the urination bag for sterile collection of one or more urine samples, one or more cotton swabs configured for use with an antiseptic skin wash, and a container containing a lubricant configured to lubricate the urethral catheter. The catheterization tray includes several compartments configured to hold the catheterization package component. The urethral catheter compartment of the catheterization tray is configured to hold the urethral catheter. The urination bag compartment of the catheterization tray is connected to the urethral catheter compartment by an inter-compartment connection. The urination bag compartment is configured to hold the urination bag. The sampling port access device compartment of the catheterization tray is configured to hold the sampling port access device. An isolated skin cleansing compartment is configured to hold one or more cotton swabs. The catheter lubrication compartment is substantially surrounded by the urethral catheter compartment. The catheter lubrication compartment is configured to hold a container containing lubricant. The catheter lubrication compartment is also configured to hold lubricant dispensed from the lubricant container. Step-by-step instructions for facilitating catheterization 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 catheterization become apparent when the catheterization package components are removed from the catheterization tray.

[0022] Disclosed herein is a method for manufacturing a catheter treatment package, the method comprising molding a catheter treatment tray configured to facilitate catheter treatment, incorporating step-by-step instructions for catheter treatment into the catheter treatment tray, and placing catheter treatment package components on the catheter treatment tray. The molding includes molding a urethral catheter compartment, molding a urine drainage bag compartment connected to the urethral catheter compartment by a compartment connection, and molding a sampling port access device compartment. Placing the catheter treatment package components on the catheter treatment tray includes placing a urethral catheter in the urethral catheter compartment, placing a urine drainage bag in the urine drainage bag compartment, and placing a sampling port access device in the sampling port access device compartment, wherein the sampling port access device is configured to be fluidly connected to a urine sampling port or a urine drainage bag of the urethral catheter for aseptic collection of one or more urine samples. The urine drainage bag is fluidly connected to the urethral catheter such that when the urethral catheter and the urine drainage bag are placed in the urethral catheter compartment and the urine drainage bag compartment, respectively, the urethral catheter is disposed across the compartment connection.

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

[0024] In some embodiments, molding the catheter treatment tray further includes molding an isolated skin cleansing compartment. Placing a catheter treatment package component on a catheter treatment tray further includes placing one or more cotton swabs in the skin cleaning compartment, placing a package of a disinfectant skin cleaning agent in the skin cleaning compartment, or placing a package of one or more cotton swabs in the disinfectant skin cleaning agent in the skin cleaning compartment.

[0025] In some embodiments, forming the catheter treatment tray further includes forming a catheter lubrication compartment at least partially surrounded by the urethral catheter compartment.

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

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

[0028] In some embodiments, the method further includes placing a sheet of paper or cardboard on top of a catheter treatment tray containing catheter treatment components to form a catheter treatment tray covered with paper or cardboard, wrapping the catheter treatment tray covered with paper or cardboard with a CSR wrap to form a catheter treatment tray wrapped with a CSR wrap, placing the catheter treatment tray wrapped with a CSR wrap in an outer package to form a catheter treatment package, and sterilizing the catheter treatment package by ethylene oxide sterilization.

[0029] These and other features of the concepts provided herein will become more apparent to those skilled in the art in consideration of the accompanying drawings and the following description, which disclose in more detail specific embodiments of such concepts. [Brief explanation of the drawing]

[0030] [Figure 1] A diagram showing at least a portion of a first catheter treatment package according to several embodiments. [Figure 2] A diagram showing several catheterization components removed from the catheterization tray of a first catheterization package, according to several embodiments. [Figure 3] A diagram showing at least a portion of a second catheter treatment package according to several embodiments. [Figure 4] A diagram showing several catheterization components removed from the catheterization tray of a second catheterization package, according to several embodiments. [Figure 5] A diagram showing at least a portion of a urination bag according to several embodiments. [Figure 6] A diagram showing an exploded view of a third catheter treatment package according to several embodiments. [Figure 7] A diagram showing at least a portion of a third catheter treatment package according to several embodiments. [Figure 8] A diagram showing at least a portion of a fourth catheter treatment package according to several embodiments. [Modes for carrying out the invention]

[0031] Before certain specific embodiments are disclosed in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that are easily separable from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of several other embodiments disclosed herein.

[0032] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of multiple features or steps and do not provide serial or numerical limitations. For example, the "1st," "2nd," and "3rd" features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left," "right," "up," "down," "front," and "back" are used for convenience and do not, for example, imply a specific 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 explicitly indicated in the context.

[0033] With respect to “proximal,” “proximal portion,” or “proximal end portion,” for example, the catheters disclosed herein include the portion of the catheter 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 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 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 may include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily 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 the 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 intended to be near or within the patient when the catheter is used in a patient. Similarly, for example, the “distal length” of a catheter includes the length of the catheter intended to be near or within the patient when the catheter is used in a patient. For example, the “distal end” of a catheter includes the end of the catheter intended to be near or within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter does not necessarily 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 those generally understood by those skilled in the art. This specification discloses a catheterization package and method for facilitating catheterization and urine sampling in efforts to reduce CAUTI and false positive results that lead to inaccurate CAUTI diagnoses.

[0036] Catheter treatment package Figure 1 shows at least a portion of the first catheter treatment package 100 according to several embodiments. Figure 2 shows several catheter treatment components removed from the catheter treatment tray 110 of the first catheter treatment package 100 according to several embodiments. Figure 3 shows at least a portion of the second catheter treatment package 300 according to several embodiments. Figure 4 shows several catheter treatment components removed from the catheter treatment tray 310 of the second catheter treatment package 300 according to several embodiments. Figure 6 shows an exploded view of the third catheter treatment package 600 according to several embodiments. Figure 7 shows at least a portion of the third catheter treatment package 600 according to several embodiments. Figure 8 shows at least a portion of the fourth catheter treatment package 800 according to several embodiments.

[0037] As shown, the catheterization packages 100, 300, 600, or 800 include the catheterization trays 110, 310, 610, or 810 and the catheterization components described below, both of which are configured to facilitate catheterization. The catheterization packages 100, 300, 600, or 800 are configured to facilitate catheterization by the catheterization components contained in the catheterization packages 100, 300, 600, or 800, by how the catheterization components are arranged in the catheterization trays 110, 310, and by the step-by-step instructions incorporated into the catheterization trays 110, 310, 610, or 810.

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

[0039] The urethral catheter compartment 112 of the catheter treatment tray 110, 310, 610, or 810 is configured to hold a urethral catheter. The urination bag compartment 114 of the catheterization tray 110, 310, 610, or 810 is connected to the urethral catheter compartment 112 by an inter-compartment connection 113. The urination bag compartment 114 is configured to hold at least a urination 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 lubricant. The catheterization tray 610 or 810 includes a catheter lubrication compartment 620 or 820 configured to hold a container containing lubricant instead of a separate sampling port access device compartment. The catheter lubrication compartment 320, 620, or 820 is also configured to hold lubricant dispensed from the lubricant container into wells 322, 622, or 822 shared with the urethral catheter compartment 112. In some embodiments of the catheterization trays 310, 610, or 810, there is no sampling port access device compartment; therefore, if the sampling port access device is included in the catheterization packages 300, 600, and 800, the urination bag compartment 114 also functions as the sampling port access device compartment for the catheterization trays 310, 610, or 810.

[0041] The skin cleansing compartment 118 of the catheterization tray 110, 310, 610, or 810 is isolated from the other compartments of the catheterization tray 110, 310, 610, or 810, which may be important for maintaining a sterile area at least around the urethral catheter compartment 112. The skin cleansing compartment 118 is configured to hold one or more swabs configured for skin cleansing 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 cleansing compartment 118 includes a well 117 and one or more channels 119, each having a snap-in tab 121 configured to hold one or more swabs therein. One or more channels 119 are angled relative to the top or bottom of the catheter treatment tray 110, 310, 610, or 810 such that when one or more stick members of one or more swabs are snapped into one or more channels 119, one or more swab heads of one or more swabs are positioned in each well 117. One or more stick members are angled upward when snapped into one or more channels 119 so that one or more stick members can be grasped and one or more swabs can be removed from one or more channels 119. Wells 117 are configured to hold an antiseptic skin wash within them. When one or more swab heads are positioned in wells 117 containing the antiseptic skin wash, the antiseptic skin wash immerses one or more swab heads for antiseptic skin washing by each of the swabs.

[0042] The catheter lubrication compartment 120 of the catheter treatment tray 110 is at least partially or substantially surrounded by the urethral catheter compartment 112. The catheter lubrication compartment 120 is configured to hold a container containing lubricant. The catheter lubrication compartment 120 is also configured to hold the lubricant dispensed from the lubricant container in a well 122 shared with the urethral 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 urethral catheter compartment 112. The specimen container compartment 324 is configured to hold a specimen container. For the specimen container compartment 324 in the catheterization tray 310, 610, or 810, the urethral catheter compartment 112 also functions as the catheter lubrication compartment of the catheterization tray 310, 610, or 810, which includes wells 322, 622, or 822 configured to hold lubricant. However, the wells 322, 622, or 822 are smaller in size compared to the well 122 of the catheterization tray 110.

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

[0045] As shown in Figures 1 and 2 or Figures 3 and 4, when the catheterization components are removed from the catheterization tray 110 or 310, at least some of the step-by-step instructions for catheterization become apparent. Also, although not shown, when the catheterization components are removed from the catheterization tray 610 or 810, at least some of the step-by-step instructions for catheterization become apparent. By making the instructions for catheterization apparent in this way, the instructional information is reduced to information that is urgent 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 certain embodiments of the catheterization package, 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 catheterization tray 310 may include all three: a sampling port access device compartment 116, a catheter lubrication compartment 320, and a specimen container compartment 324. Such a configuration may include a catheterization tray 310 with a catheter lubrication compartment 320 and a urination bag compartment 114 as shown in Figure 3, and an additional compartment (not shown) corresponding to a sampling port access device compartment 116 between the catheter lubrication compartment 320 and the urination bag compartment 114.

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

[0048] With regard to catheterization components comprising catheterization trays 110, 310, 610, or 610, the catheterization components may include, but are not limited to, a urethral catheter 130, a urination bag 140 or 640, a sampling port access device 150, a test tube 160 with one or more septum stoppers, a specimen container 170, a container containing one or more cotton swabs 180, a lubricant 190, or a combination thereof.

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

[0050] Figure 5 shows at least a portion of the urination bag 140 according to several embodiments. The urination 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 using a sampling port access device 150. Also, as shown in Figure 5, the urination bag 140 includes an optional channel 148 configured to receive intermittent catheters, such as urethral catheters 130, following their use, for disposing of intermittent catheters together with the urination bag 140.

[0051] The urination bag 640 differs from the urination bag 140, at least in terms of the arrangement 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. Furthermore, the tubing clamp 642 is coupled to the urination bag 640 so that it 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 urethral catheter 130.

[0052] The sampling port access device 150 is configured to fluidly connect to a urine sampling port on a urethral catheter 130 (e.g., a urine sampling port on a Foley catheter) or a urine sampling port 146 on a urination 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 on the urethral catheter or the urine sampling port 146 on the urination bag 140 (see Figure 3 for the sampling port access device 150 fluidly connected to the urine sampling port 146 on the urination 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] One or more test tubes 160 with septum stoppers are configured for use with a sampling port access device 150. Each of the one or more test tubes 160 has an internal pressure lower than atmospheric pressure so that urine is drawn into the test tube from the urine sampling port 146 of the urethral catheter 130 or the urine sampling port 146 of the urination bag 140 when certain conditions are met. For example, when the urination 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 urination bag 140, and the septum stopper of the test tube is punctured by the needle 156 of the sampling port access device 150, urine is drawn into the test tube. Each test tube is independently configured to contain a preparation for urinalysis, a preparation for microbiological analysis, or to be free of additives and 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 outlet port 144 of the urination bag 140, thereby providing an alternative means of sterile collection of one or more urine samples as needed. As shown at least in Figure 6, the specimen container 170 includes a cap 172 configured to seal the urine sample inside the specimen container 170. A label 174 is optionally included in the catheterization package 100, 300, 600, or 800 to label the specimen container 170 according to any urine sample inside. Clean collection of one or more urine samples utilizes the outlet port 144 of the urination bag 140 and the specimen container 170 to reduce the transfer of microorganisms from healthcare workers and the environment to one or more urine samples. However, in order to reduce as well as prevent the transfer of microorganisms from healthcare workers and the environment to one or more urine samples, sterile collection of one or more urine samples requires the use of a sampling port on a urethral catheter or a sampling port 146 on a urination bag 140, a sampling port access device 150, and one or more test tubes 160.

[0055] One or more cotton swabs 180 are configured for skin cleansing with an antiseptic skin cleanser. Optionally, one or more cotton swabs 180 are already snapped into one or more channels 119 of the skin cleansing compartment 118 by one or more stick members within a catheter procedure package 100, 300, 600, or 800. As shown only in Figures 6 and 7, the catheter procedure package 100, 300, 600, or 800 may include a package of antiseptic skin cleanser 182, which may be, for example, a povidone-iodine solution to be poured into the wells 117 of the skin cleansing compartment 118 to immerse one or more swab heads of the one or more cotton swabs 180, respectively, for skin cleansing. Alternatively, one or more cotton swabs 180 are packaged in a package of antiseptic skin cleanser 182.

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

[0057] Although not shown, the catheterization components comprising the catheterization trays 110, 310, 610, or 810 may, but are not limited to, include one or more pairs of examination gloves and underpads. The one or more pairs of gloves and underpads are configured for use during catheterization procedures, such as during skin cleansing with an antiseptic skin wash, during lubrication of the urethral catheter 130 with a lubricant in a container containing a lubricant 190, and during insertion of the urethral catheter 130 into the patient. The one or more pairs of gloves can be placed in or on any compartment of the catheterization trays 110, 310, 610, or 810. The underpads can be folded and placed under, between, or on top of one or more pairs of gloves.

[0058] Although not shown, catheterization packages 100, 300, 600, or 800 further include packaging for catheterization packages 100, 300, 600, or 800. Packaging includes a sheet of paper or cardboard, CSR wrap, and outer packaging for catheterization packages 100, 300, 600, or 800.

[0059] A sheet of paper or cardboard is configured to cover the catheterization tray 110, 310, 610, or 810 and the catheterization components within it. Figures 1–4, 6, and 7 show the lip around the catheterization tray 110, 310, 610, or 810, on which the sheet of paper or cardboard is placed. Optionally, the paper or cardboard may contain product information or additional instructions to step-by-step instructions printed thereon.

[0060] The CSR wrap is configured to maintain the sterile condition 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 catheterization package 100, 300, 600, or 800 from the time of assembly until the time of use. The outer packaging is also configured to prevent contamination of the contents of the catheterization package 100, 300, 600, or 800 from the time of ethylene oxide sterilization until the time of use.

[0062] method A method for manufacturing a catheterization package 100, 300, 600, or 800 includes molding a catheterization tray 110, 310, 610, or 810; incorporating step-by-step instructions for catheterization into the catheterization tray 110, 310, 610, or 810; and arranging catheterization components in the catheterization tray 110, 310, 610, or 810. Molding includes molding a urethral catheter compartment 112; molding a urination bag compartment 114 connected to the urethral catheter compartment 112 by an inter-compartment connection 113; and, in some embodiments of the catheterization tray 110 and the catheterization tray 310, molding a sampling port access device compartment 116. Placing catheterization components in catheterization trays 110, 310, 610, or 810 includes placing the urethral catheter 130 in the urethral catheter compartment 112, the urination bag 140 in the urination bag compartment 114, and, if such a compartment exists, placing the sampling port access device 150 in the sampling port access device compartment 116. Otherwise, the sampling port access device 150 may be placed in the urination bag compartment 114 as needed. The urethral catheter 130 is fluidly connected to the urination bag 140 such that the urethral catheter 130 is positioned across the inter-compartment connection 113 when the urethral catheter 130 and the urination bag 140 are placed in the urethral catheter compartment 112 and the urination bag compartment 114, respectively.

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

[0064] Molding the catheter treatment trays 110, 310, 610, or 810 may further include molding an isolated skin cleansing compartment 118. Placing catheterization components within the catheterization tray 110, 310, 610, or 810 may further include placing one or more cotton swabs 180 within the skin cleansing compartment 118, placing a package of disinfectant skin cleanser 182 within the skin cleansing compartment 118, or placing a package of one or more cotton swabs 180 in disinfectant skin cleanser within the skin cleansing compartment 118.

[0065] Molding the catheter treatment 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 a urethral catheter compartment 112 or a skin cleansing compartment 118 and a urination bag compartment 114.

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

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

[0068] The method may further include: placing a sheet of paper or cardboard on a catheterization tray 110, 310, 610, or 810 containing catheterization components to form a paper or cardboard-covered catheterization tray; wrapping the paper or cardboard-covered catheterization tray with CSR wrap to form a CSR wrap-wrapped catheterization tray; placing the CSR wrap-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] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can be understood by those skilled in the art, and in broader embodiments, these adaptations and / or modifications are also encompassed. Thus, one can deviate from any particular embodiment disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheterization package, comprising a catheterization component, the catheterization component is Urethral catheter and A urinary bag fluidly connected to the urethral catheter, A container containing a lubricant configured to lubricate the urethral catheter in accordance with catheterization procedures, The system comprises a catheter treatment tray configured to facilitate catheter procedures, and the catheter treatment tray is A first compartment configured to hold the urethral catheter, A second compartment is connected to the first compartment by an inter-compartment connection and is configured to hold the urination bag, A container containing the lubricant, and a catheter lubrication compartment configured to hold the lubricant dispensed from the container, wherein the catheter lubrication compartment is at least partially surrounded by the first compartment, The catheter procedure tray includes step-by-step instructions for catheter procedures, The first compartment is, The first and second parts are located on opposite sides of the catheter lubrication compartment, A third part that connects the first part and the second part, A catheterization procedure package equipped with the following features.

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

3. A method for manufacturing a catheter treatment package, To mold a catheterization tray configured to facilitate catheterization, The step-by-step instructions for catheter procedures are incorporated into the catheter procedure tray, The catheter treatment components are placed in the catheter treatment tray, Equipped with, Molding the aforementioned catheter treatment tray is To shape the urethral catheter compartment, To form a urination bag compartment connected to the urethral catheter compartment by inter-compartment connection, A catheter lubrication compartment configured to hold a container containing a lubricant and to hold the lubricant dispensed from the container, and the catheter lubrication compartment being at least partially surrounded by the urethral catheter compartment, Equipped with, The urethral catheter compartment is, The first and second parts are located on opposite sides of the catheter lubrication compartment, A third part that connects the first part and the second part, Equipped with, Placing the catheter treatment components in the catheter treatment tray is The urethral catheter is placed in the urethral catheter compartment, Placing the urination bag in the urination bag compartment, wherein the urination bag is fluidly connected to the urethral catheter, such that placing the urethral catheter and the urination bag in the urethral catheter compartment and the urination bag compartment, respectively, includes arranging the urethral catheter so as to cross the compartment-to-compartment connection, The container containing the lubricant is placed in the catheter lubrication compartment, A method that includes [a certain feature].

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

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