CN110913938A

CN110913938A - Catheterization tray with integrated instructions

Info

Publication number: CN110913938A
Application number: CN201780092085.2A
Authority: CN
Inventors: D·胡戈特; R·里谢尔; J·戈德
Original assignee: CR Bard Inc
Current assignee: CR Bard Inc
Priority date: 2017-04-13
Filing date: 2017-04-14
Publication date: 2020-03-24
Anticipated expiration: 2037-04-14
Also published as: EP3609561A1; KR102622098B1; AU2023203963A1; AU2017409008A1; CN110913938B; AU2017409008B2; WO2018190865A1; CA3058887A1; BR112019021090A2; MX2019012210A; SA519410281B1; ZA201906629B; JP2020518322A; KR20230026519A; JP7013481B2; EP3609561A4; KR20190132698A

Abstract

An improved medical procedure tray or catheterization tray for inclusion in an improved medical procedure or catheterization package. The improved medical procedure tray or catheterization tray is intuitively arranged and includes instructions printed thereon to improve medical procedure or catheterization performance and results. In one embodiment, the urinary catheterization package and tray have a component layout and/or arrangement that may help reduce CAUTI rates by facilitating ease of use and helping with proper aseptic techniques during insertion. The medical procedure package or catheterization package and/or the medical procedure tray or catheterization tray may include various implements, chambers, and components necessary and/or useful for a medical procedure or catheterization, including, for example, a modified swab and a modified chamber for holding a swab.

Description

Catheterization tray with integrated instructions

Priority

The present application claims the benefit of U.S. patent application No. 15/487,297 filed on day 4 and 13 in 2017, which is a continuation-in-part application of U.S. patent application No. 15/029,613 filed on

day

4 and 14 in 2016, which is the U.S. national phase of international patent application No. PCT/US2014/060963 filed on day 16 in 2014, which claims the benefit of U.S. provisional patent application No. 61/891,496 filed on day 16 in 10 in 2013 and U.S. provisional patent application No. 62/015,206 filed on day 20 in 6 in 2014, each of which is incorporated herein by reference in its entirety.

Background

Urinary drainage systems are commonly used in hospitals and healthcare facilities when it is desired to facilitate, control, monitor the urination of a patient, and when it is desired to collect urine from a patient. These urinary drainage systems allow the patient to remain in bed without having to use a bedpan or move the patient to a bathroom. The urinary drainage system may include a catheter (e.g., a urinary catheter, such as an intermittent catheter or Foley catheter), a collection container/bag (e.g., a bag made of polymeric material or PVC film), a urine meter, tubing connecting the Foley catheter to the collection container/bag or urine meter, and/or other equipment. In operation, a patient is first catheterized and a catheter is connected to a drainage container/bag and/or urine meter by a length of tubing (e.g., drainage tubing). Urine drains through the catheter, tubing, and then ultimately into a collection container/bag and/or urine meter. Urine can move from the catheter into the collection bag due to gravity alone. On average, patients produce about 80-90mL of urine within 1 hour.

Accurate monitoring of urine helps clinicians detect irregularities in urine flow rate or volume that can signal the clinician that the patient is suffering from certain problems. However, if the drainage system attached to the Foley catheter is unreliable, or if the Foley catheter and drainage system are improperly used, then urine output cannot be accurately measured. Further, hospitals are using lower and lower posture (low-profile) beds in order to reduce the number of people who fall from the bed and are injured. The amount of available height to allow the tubing to drain is reduced due to the use of a lower profile bed. Drainage tubing and associated ventilation systems used in hospitals have also undergone changes/modifications. The change in ventilation combined with the lower and lower attitude of the hospital bed results in poor drainage performance. For example, urine has been observed to pool in the tubing. This prevents accurate urine output measurements and accurate urine flow rate measurements that are critical to many patients.

Currently, the second common form of hospital-acquired infection (HAI) is catheter-associated urinary tract infection (CAUTI). Hospitals are interested in methods to cut CAUTI rates by adhering to strict aseptic techniques as a standard of care. However, there are many factors that affect the ability of a hospital to meet standard of care. These factors include: experience and training of the healthcare practitioner/nurse, patient factors (e.g., overall health, weight, and anatomy), environmental factors, tray layout, and contents and instructions/directions. A catheterization package and/or tray with program-optimized components and intuitive layout may improve compliance with sterile techniques, thereby potentially reducing CAUTI rates.

In the field of health care, there is a need for a more reliable, safe and easy way to insert a catheter, such as a urinary catheter, e.g. an indwelling catheter or an intermittent catheter, into a patient. More particularly, there is a need to provide a urinary bag and/or tray (e.g., Foley catheter tray) that improves and standardizes the procedure for inserting urinary catheters, such as indwelling Foley catheters, into a patient.

The present disclosure provides a urinary catheter, catheter tray, and drainage system configured to better meet patient needs, improve reliability and ease of use, reduce CAUTI events, improve safety, and address other problems described above and elsewhere herein.

Disclosure of Invention

Described herein are embodiments and enhancements of packages, systems, trays, assemblies, devices, methods, etc. for medical treatment in general and for catheterization in particular.

The goals described herein may be met by providing an improved medical kit and/or tray (e.g., an improved catheterization kit and/or an improved catheterization tray). The retrofit medical procedure package may include a retrofit medical procedure tray therein, and the medical procedure tray may be arranged visually and may include instructions or procedure instructions for improving the implementation and results of the medical procedure. The medical procedure package and/or medical procedure tray can include various instruments and components necessary and/or useful for a medical procedure. For example, the improved catheterization package may include an improved catheterization tray, a povidone-iodine swab or swab stick that allows for greater coverage and saturation, a hand sanitizing gel with improved efficacy and that can be used with one hand, tubing that disrupts the surface tension of the fluid for improved drainage, and/or other components described herein.

According to various embodiments, the present disclosure provides a urinary catheterization package and a urinary catheterization tray having a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and helping to achieve proper aseptic techniques during insertion. The present disclosure also provides methods of catheterization and the use of a catheterization package and/or a catheterization tray that may facilitate easier and more sterile catheterization to help reduce CAUTI rates. Further, the present disclosure provides a system that may improve drainage performance, which in turn: (1) help eliminate fluid in the drain tube, and (2) increase the accuracy of urine measurements (e.g., measurements of output volume and flow rate).

In some embodiments, a urinary catheterization package is provided that includes a urinary catheterization tray and a sterile wrap surrounding the urinary catheterization tray. The catheterization tray may include catheterization instructions directly imprinted on the catheterization tray. The urinary tray may further include a first portion, a second portion, and a third portion, wherein one or more dividers may separate at least the third portion from the first and second portions. The first portion may hold a drainage system, the second portion may hold a container containing a lubricant, and the third portion may hold the swab in an inclined position. The absorbent head of the swab may be angled downwardly into the well of the third portion, and the elongated member of the swab may be angled upwardly for grasping and removing the swab.

In such embodiments, the urinary catheterization package may further include a perineal care kit, a binder, and a packaging label. The perineal care kit may be packaged with the catheterization tray, but outside the sterile wrap. One example of a suitable perineal care kit is disclosed in PCT application publication No. WO 2016/126555, the disclosure of which is incorporated herein by reference in its entirety. The abdominal band may be external to the sterile wrap, holding the sterile wrap in a folded configuration around the urinary catheterization tray. The packaging label may be used to identify the catheterization package outside the sterile wrap.

In such embodiments, the third portion of the catheterization package may include a swab chamber, an overflow chamber, and a corner storage chamber that holds the sample container. The swab chamber may include a well and a channel configured to hold a swab. The channel may include at least two snap tabs to hold the swab in the channel below the snap tabs, wherein each longitudinal side of the channel includes at least one of the at least two snap tabs. The channel may also be configured to convey fluid into the well when the swab is not in the channel and fluid is poured in the channel. The overflow chamber may be fluidly connected to the well through the channel.

In such embodiments, the one or more dividers of the urinary catheterization package that separate the third portion from the first and second portions may further separate the second portion from the first portion. A second portion of the one or more dividers may have a maximum height equal to a height of the urinary catheterization tray, wherein a bottom of the second portion may be elevated above the bottom of the urinary catheterization tray. Alternatively, the second partial divider of the one or more dividers may have a maximum height that is less than the height of the catheterization tray, wherein the bottom of the second portion and the bottom of the catheterization tray are substantially coplanar.

In some embodiments, a medical procedure package is provided that includes a tray having medical procedure instructions directly imprinted on the tray, at least some of which are revealed in synchronization with steps of a medical procedure. The tray may include a first portion, a second portion, and a third portion, wherein one or more dividers separate at least the third portion from the first and second portions. The tray may also include a drainage system, a container containing a lubricant, and one or more swabs. The first part may comprise at least a drainage system, the second part may comprise at least a container containing a lubricant, and the third part comprises at least one or more swabs.

In such embodiments, the medical kit may further comprise a sample container. The third portion may include a swab chamber, an overflow chamber, and a corner storage chamber including a sample container. The swab chamber may include a well and one or more channels configured to retain the one or more swabs in the one or more channels, respectively, using snap tabs. The one or more channels may also be angled relative to the bottom of the tray such that the handle end of each of the one or more swabs held below the snap tab is elevated relative to the absorbent head end when the absorbent head end is in the well. The overflow chamber may be fluidly connected with the well by the one or more channels, wherein the one or more channels may be further configured to convey fluid poured therein to the well when the one or more swabs are removed from the one or more channels.

In such embodiments, the medical kit may further include a third portion separator of the one or more separators at the well end of the swab chamber that directly separates the well from the second portion. Alternatively, the well end of the swab chamber may share an inner wall of the tray with the tray.

In such embodiments, the one or more dividers of the medical package that separate the third portion from the first and second portions may further separate the second portion from the first portion. A second portion of the one or more dividers may have a maximum height equal to a height of the tray, wherein a bottom of the second portion may rise above the bottom of the tray. Alternatively, the second partial divider of the one or more dividers may have a maximum height that is less than a height of the tray, wherein a bottom of the second portion and a bottom of the tray are substantially coplanar.

In some embodiments, a urinary catheterization package is provided that includes a tray having catheterization instructions directly imprinted on the tray, at least some of which are revealed in synchronization with the steps of catheterization. The tray may include a first portion, a second portion, and a third portion, wherein one or more dividers separate at least the third portion from the first and second portions. The tray may also include a drainage system, a container containing a lubricant, a sterile liquid (such as water or, in some cases, saline) syringe, and a skin preparation kit. The first portion may include at least a drainage system, which may include a Foley catheter, a drainage tube, and a drainage bag. The second part may comprise at least a reservoir containing a lubricant. The first portion may include a sterile liquid (such as sterile water) syringe, which may be configured to inflate a balloon of a Foley catheter using sterile water. According to certain embodiments, a water syringe may be connected to the inflation port of the Foley catheter during manufacture of the assembly. Providing a syringe pre-connected to a Foley catheter may help minimize the number of steps required to catheterize a patient. The third portion may include at least a skin preparation kit, which may include a sanitizer pack and one or more swabs.

In such embodiments, the catheterization package may also include a sample container and a label for the sample container. The third portion may include a swab chamber, an overflow chamber, and a corner storage chamber including a sample container. The swab chamber may include a well and one or more channels configured to retain the one or more swabs in the one or more channels, respectively, using snap tabs. The overflow chamber may be fluidly connected to the well by the one or more channels, wherein the one or more channels may be further configured to send disinfectant poured therein to the well when the one or more swabs are removed from the one or more channels. A disinfectant pack may be placed over the swab chamber, the overflow chamber, the corner storage chamber, or a combination thereof.

In such embodiments, the urinary catheterization package may further include a third portion separation divider of the one or more dividers at the well end of the swab chamber that directly separates the well from the second portion. Alternatively, the well end of the swab chamber may share an inner wall of the tray with the tray.

In such embodiments, the one or more dividers of the urinary catheterization package that separate the third portion from the first and second portions may further separate the second portion from the first portion. A second portion of the one or more dividers may have a maximum height equal to a height of the tray, wherein a bottom of the second portion may rise above the bottom of the tray. Alternatively, the second partial divider of the one or more dividers may have a maximum height that is less than a height of the tray, wherein a bottom of the second portion and a bottom of the tray are substantially coplanar.

In such embodiments, the urinary catheterization package may further include a sterile wrap, a perineal care kit, a binder, and a packaging label. The sterile wrap may be in a folded configuration around the tray. The perineal care kit may be packaged with the catheterization tray, but outside the sterile wrap. The abdominal band may be external to the sterile wrap, holding the sterile wrap in a folded configuration around the urinary catheterization tray. The binder may also include instructions on how to orient the tray prior to opening the sterile wrap. The packaging label may be used to identify the catheterization package outside the sterile wrap. In addition, the package label may include information that emphasizes key features of the urinary catheter package in an easy to read manner.

In some embodiments, the urinary catheterization package includes a urinary catheterization tray, the urinary catheterization tray including: a first chamber holding a drainage system; a second chamber holding a syringe; a third chamber holding a swab in a tilted position such that an absorbent head of the swab is biased downwardly into a well of the third chamber and an elongate member of the swab is angled upwardly for easier grasping and removal; and a catheterization instruction or program instruction directly imprinted on the catheterization tray. The urinary catheterization package may also include a sterile wrap (e.g., CSR wrap) wrapped around the urinary catheterization tray. The absorbent head of the swab may be formed of absorbent foam and the elongated member of the swab may have a generally rectangular cross-section with rounded edges. The urinary catheterization package may further include a perineal care kit packaged with the urinary catheterization tray at a location external to the sterile wrap. The urinary catheterization package may also include a belly band outside the sterile wrap that includes instructions or procedural instructions as to how to orient the catheterization tray prior to opening the sterile wrap. Additionally, the urinary catheterization package may include a packaging label outside the sterile wrap, wherein the packaging label includes at least three sides folded to a different plane than the top of the label, which are visible when the urinary catheterization package is viewed from one or more sides of the urinary package, and/or wherein the packaging label includes information features (e.g., information squares) that each emphasize key features of the urinary package in an easy-to-read manner. The catheterization package may include an externally sealed container or bag (e.g., a plastic transparent bag) around other components to maintain sterility during transport and storage.

In some embodiments, a medical procedure package includes three or more chambers holding instruments for performing a medical procedure; and instructions/procedures instructions directly imprinted on or included on the medical procedure tray that instruct a user how to perform medical procedure steps, wherein the three or more chambers, the instructions/procedures instructions, and the instruments of the medical procedure tray are arranged in an arrangement such that a medical procedure visually proceeds from one step to another based on the arrangement. The arrangement may include stacking various components or implements (e.g., 2 to 20 implements/components or 4 to 10 implements/components) on top of each other in the order they are to be used (e.g., a component or implement to be used before another component or implement is on top of the other component or implement to be used later).

In some embodiments, a method of treating a patient includes providing a medical procedure tray comprising three or more compartments including instruments for performing a medical procedure and instructions/procedure instructions directly imprinted on the medical procedure tray that instruct a user how to perform the steps of the medical procedure. The method may further include performing the medical procedure on the patient while following the instructions/procedure instructions imprinted on the medical procedure tray. The three or more compartments, instructions/procedure instructions, and/or instruments of the medical procedure tray are arranged such that the medical procedure intuitively proceeds from one step to another based on how they are arranged on/in the medical procedure tray.

In some embodiments, a method of catheterizing a patient includes providing a catheterization package having a catheterization tray including: a first chamber holding a drainage system comprising a catheter; a second chamber holding a swab in an inclined position such that an absorbent head of the swab is biased downwardly into a well of the second chamber and an elongate member of the swab is angled upwardly; the method includes pouring a disinfectant solution into the well, contacting the absorbent head with the disinfectant solution, using the swab to clean the patient in the area where the catheterization is to be performed, and inserting a portion of the catheter into the urethra of the patient. A sealed container or bag may be disposed about the catheterization tray, and the method may include unsealing the sealed container or bag. The sterile wrap may be wrapped around the catheterization tray, and the method may include unpacking the sterile wrap prior to pouring the disinfectant solution into the well. The urinary catheterization package may further include a perineal care kit located outside the sterile wrap, and the method may include cleaning a portion of the patient's perineum using the perineal care kit prior to unpacking the sterile wrap. The abdominal band may be positioned outside the sterile wrap, the abdominal band may include one or more instructions/program instructions regarding how to properly orient the catheterization tray prior to unwrapping the sterile wrap, and the method may include orienting the tray according to the instruction (s)/program instruction(s) prior to unwrapping the sterile wrap.

In some embodiments, a method of manufacturing a urinary catheterization package includes providing a urinary catheterization tray including a first chamber, a second chamber, a third chamber (having a channel for holding a swab) having an angled portion of the chamber bottom, and a urinary catheterization instruction/program instruction printed directly on the urinary catheterization tray; wherein the first chamber, the second chamber, and the third chamber are all at least partially separated from one another by a divider. The method may further include positioning a drainage system in the first chamber, positioning a syringe in the second chamber, and positioning a swab in the third chamber such that an absorbent head of the swab is biased downward into a well of the third chamber and an elongate member of the swab is angled upward for easier grasping and removal. The method may further include wrapping the catheterization tray in a sterile wrap and positioning a belly band around a portion of the sterile wrap, the belly band including one or more instructions/procedural instructions regarding how to properly orient the catheterization tray prior to opening the sterile wrap. Further, the method may include adding a perineal care kit including a zippered pouch containing a cleaning tissue, hand sanitizing gel, and instructions/procedures for cleaning the patient to the catheterization tray outside of the abdominal belt and sterile wrap. The method may include adding a file with detailed catheterization instructions and/or program instructions to the catheterization package. Further, the method may include: placing a packaging label on top of the urinary catheter, the packaging label comprising at least three side portions folded from a top portion; and/or placing a packaging label on top of the urinary catheter, the packaging label comprising one or more informational features that each emphasize one or more key features of the urinary catheter in an easy to read manner. The one or more information features may be one or more information blocks. The method may further comprise sealing (e.g., by heat sealing) the transparent plastic bag around the catheterization package.

In some embodiments, the catheterization system includes a container for securing the catheterization component. The container has a housing defining a general shape of the container and a plurality of chambers within the housing. Each of the plurality of chambers is separated from one or more adjacent chambers of the plurality of chambers by one or more dividers. The plurality of chambers includes a first chamber sized and configured to contain a conduit assembly, and one or more secondary chambers separated from the first chamber by the one or more dividers. At least one of the one or more secondary chambers includes at least one partial divider (e.g., a divider including a reduced height portion) of the one or more dividers.

In some embodiments, a catheterization system for performing catheterization is provided. The urinary catheterization system includes a urinary catheterization tray having a housing defining a general shape of a container and a plurality of chambers within the housing. Each of the plurality of chambers is separated from one or more adjacent chambers of the plurality of chambers by one or more dividers. The plurality of chambers may include a first chamber containing a conduit assembly, and one or more secondary chambers separated from the first chamber by one or more dividers. At least one of the one or more secondary chambers may include at least one partial divider of the one or more dividers (e.g., a divider including a reduced height portion). Additionally, the catheterization system includes one or more swabs located within a second chamber of the one or more secondary chambers.

Drawings

Embodiments and enhancements of the disclosed packs, trays, devices, systems, and methods can be better understood with reference to the following drawings. Some of the material in this patent document is subject to copyright protection by the copyright laws of the united states and other countries. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the U.S. patent and trademark office publicly available file or records, but otherwise reserves all copyright rights whatsoever.

Fig. 1 shows a top view of a medical procedure tray including integrated instructions/procedures in the form of a catheterization tray.

Fig. 2 shows a top right front (or proximal) perspective view of the medical procedure tray of fig. 1.

Fig. 3 shows a right side elevation view of the medical procedure tray of fig. 1.

Fig. 4 shows a rear (or distal) elevation view of the medical procedure tray of fig. 1.

Fig. 5 shows a top view of another medical procedure tray that includes integrated instructions/procedure instructions in the form of a catheterization tray that is larger than the tray in fig. 1.

Fig. 6A shows a top view of a swab or swab stick that may be included in a urinary catheterization bag and/or tray.

Fig. 6B shows a side perspective view of the swab or swab stick of fig. 6A.

Fig. 6C shows an end view of the swab or swab wand of fig. 6A to show the cross-sectional shape of the elongated member or wand.

Fig. 7A shows a top view of a swab or swab stick that may be included in a urinary catheterization bag and/or tray.

Fig. 7B shows a side perspective view of the swab or swab stick of fig. 7A.

Fig. 7C shows an end view of the swab or swab wand of fig. 7A to show the cross-sectional shape of the elongated member or wand, which is different from the cross-sectional shape shown in fig. 6C.

Fig. 8 shows a top view of the swab chamber and the small storage or overflow chamber of a catheterization tray that includes a swab or swab stick similar to the swab or swab stick shown in fig. 7A-7C, with one of the swabs or swab sticks rotated approximately 90 ° to release it from the fastening feature (security feature) of the swab chamber.

Figure 9 shows a top view of a urinary catheterization package sealed in a sealed bag and having a package label with information squares on its top and sides that provide easy viewing characteristics even if the urinary bag is in a stack of other urinary catheterization bags.

Figure 10 shows a top front perspective view of another catheterization package (different from that shown in figure 9) sealed in a sealed bag and having a package label with information squares on its top and sides (one of which is visible) that provide easy viewing characteristics even if the catheterization package is in a stack of other catheterization packages.

Fig. 11 shows a top view of the fig. 9 urinary catheter package outside the sealed bag, but still having the same packaging label thereon.

FIG. 12 shows a top expanded view of the package label of the urinary catheter of FIG. 10, including lines added to show where the sides may be folded when placed over the other components of the urinary catheter prior to sealing the urinary catheter in the sealed pouch.

Fig. 13 shows a top view of a catheterization package (e.g., the catheterization package of fig. 9 or 10) after removal of the sealed pouch and packaging label, and a detailed instructions/program instructions file or instructions for use (DFU) file is shown thereon.

FIG. 14A shows one page of a detailed catheterization description/procedure instruction file or a usage Description (DFU) file that may be included in a catheterization package.

FIG. 14B shows another page of the detailed catheterization description/procedure instruction file or usage Description (DFU) file of FIG. 14A.

FIG. 14C shows another page of the detailed catheterization description/procedure instruction file or usage Description (DFU) file of FIG. 14A.

FIG. 14D shows another page of the detailed catheterization description/procedure instruction file or usage Description (DFU) file of FIG. 14A.

Fig. 15A shows a front side of a patient educational information sheet/book that may be included in a urinary catheterization package.

Fig. 15B shows the back of the patient educational information sheet/book of fig. 15A.

Fig. 16 shows a top view of the catheterization package of fig. 13 without a specification/program instruction file or a instructions for use (DFU) file and showing a label or insert thereon.

Fig. 17 shows a top view of a urinary catheterization package without a label or insert (e.g., similar to the urinary catheterization package of fig. 16), and shows a perineal care or perineal care kit/package thereon.

Fig. 18 shows a top view of a urinary catheterization package without a label or insert (e.g., similar to the urinary catheterization package of fig. 16), and shows another different perineal care or perineal care kit/package thereon.

Fig. 19 shows an isolated view of the components of the perineal care (or perineal care) kit or pack of fig. 18.

Fig. 20 shows a top view of a catheterization package (e.g., similar to the catheterization package of fig. 17 or 18) without a perineal care (or perineal care) kit or bag and shows the abdominal belt with instructions/procedures included thereon.

Fig. 21 shows a top view of a urinary catheterization package without a binder (e.g., similar to the urinary catheterization package of fig. 20 or 21), and shows the sterile wrap folded/wrapped only partially around the urinary catheterization tray.

Fig. 22 shows a top view of the fig. 22 urinary catheterization package with the sterile wrap fully unfolded, but remaining under the catheterization tray, and showing the contents of the catheterization tray prior to removal of any components, or after all components within the sterile wrap have been placed within the catheterization tray during manufacturing/packaging.

FIG. 23 shows a top view of the catheterization package of FIG. 23 with the sterile glove bag partially unfolded and positioned on top of the catheterization tray.

Fig. 24 shows a top view of the catheterization package of fig. 24 without a sterile glove bag and reveals a padding/hole towel (representing the waterproof padding and/or hole towel) on top of the catheterization tray.

Fig. 25 shows a top view of the catheterization package of fig. 25 with the padding/hole towel moved out of the wipe chamber and revealing a povidone-iodine solution package located in the wipe chamber and extending over the mini-storage or overflow chamber of the catheterization tray.

Fig. 26 shows a top view of the urinary catheterization package of fig. 26 without the povidone-iodine solution, and reveals a swab or swab wand in the swab chamber, with the proximal end of the swab wand extending above the mini-storage or overflow chamber of the urinary catheterization tray.

Fig. 27 shows a top view of the urinary catheter of fig. 27 with a sterile liquid syringe attached to the inflation port of the catheter.

FIG. 28 shows a top view of the FIG. 28 urinary catheter package with the distal portion of the catheter in a syringe or catheter chamber (system or catheter kit) and a lubricous gel syringe adjacent the syringe or catheter chamber ready to dispense lubricous gel on top of the distal region or distal end of the catheter.

Fig. 29 shows a top view of the urinary catheterization package of fig. 29 after the catheter has been removed from the tray and inserted into the patient, with the drainage tube extending in the direction of the patient.

FIG. 30A is a top view of the catheterization system;

FIG. 30B is a top view of the catheterization tray of the catheterization system of FIG. 30A wrapped in a wrapper;

figure 31A is an isometric view of a catheter tray and its contents;

FIG. 31B is an isometric view of the catheterization tray of FIG. 31A with some of the contents removed therefrom;

FIG. 31C is a back isometric view of the catheterization tray of FIG. 31A;

FIG. 32 is a top view of the catheterization tray of FIG. 31A with all contents removed therefrom;

FIG. 33 is a top view of the urinary catheterization system;

FIG. 34 is a top view of a hole towel;

FIG. 35 is an isometric view of a swab;

FIG. 36A is an isometric view of a catheterization system;

FIG. 36B is an isometric view of a catheterization tray of the catheterization system of FIG. 36A;

FIG. 37A is an isometric view of a catheterization system;

FIG. 37B is an isometric view of a partially deployed catheterization tray of the catheterization system of FIG. 37A; and

FIG. 37C is a partial isometric view of a deployed catheterization tray of the catheterization system of FIG. 37A.

Fig. 38A shows a view of another medical procedure tray, according to some embodiments.

Fig. 38B shows another view of the medical procedure tray of fig. 38A.

Fig. 38C shows another view of the medical procedure tray of fig. 38A along with a lid.

Fig. 38D shows another view of the medical procedure tray of fig. 38A along with a lid.

Fig. 39A shows a view of another medical procedure tray, according to some embodiments.

Fig. 39B shows another view of the medical procedure tray of fig. 39A.

Fig. 39C shows a view of a medical procedure tray including a plurality of holders in a first configuration, according to some embodiments.

Fig. 39D shows a view of a medical procedure tray including a plurality of holders in a second configuration, according to some embodiments.

Fig. 40A shows a view of another medical procedure tray, according to some embodiments.

Fig. 40B shows another view of the medical procedure tray of fig. 40A.

Fig. 41A shows a view of another medical procedure tray, according to some embodiments.

Fig. 41B shows another view of the medical procedure tray of fig. 41A.

Fig. 41C shows another view of the medical procedure tray of fig. 41A.

Fig. 42A shows a view of another medical procedure tray, according to some embodiments.

Fig. 42B and 42C show other views of the medical procedure tray of fig. 42A.

Fig. 43 shows a view of another medical procedure tray, according to some embodiments.

Fig. 44A shows a view of a removable retainer on a divider or side of a medical procedure tray, according to some embodiments.

Fig. 44B shows another view of a removable holder with hidden instruction labels on a divider or side of a medical procedure tray, according to some embodiments.

Fig. 44C shows another view of a removable holder with an exposed instruction label on a divider or side of a medical procedure tray, according to some embodiments.

Fig. 45 shows a view of an add-on retainer on a side of a medical procedure tray, according to some embodiments.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Detailed Description

The following description and drawings that describe and illustrate certain embodiments are intended to present, in a non-limiting manner, several possible configurations of medical procedure packages, medical procedure trays, catheterization packages, catheterization trays and associated components, assemblies, systems, etc., as well as various methods of manufacture and methods of using these methods in accordance with various aspects and features of the present disclosure.

Various packages, kits, trays, systems, assemblies, devices, and methods are described herein, including packages, kits, trays, systems, assemblies, devices, and methods for various medical procedures, including, for example, catheterization. Although specific embodiments have been described herein by way of example, the described embodiments and examples are not intended to be limiting. Thus, while aspects of the invention may be described as, for example, a catheterization package, a catheterization tray, a catheterization procedure, etc., the disclosure is not limited to catheterization-related packages, trays, systems/components, procedures, etc. Rather, the inventive principles associated with the embodiments described herein may be applied to other embodiments and other types of packages, trays, systems/assemblies, devices, methods, and the like.

According to various embodiments, the objects described above and elsewhere herein may be achieved by providing an improved medical procedure package or kit that includes a medical procedure tray, e.g., having a more intuitive or better organized layout, instructions/procedure instructions, etc., included on the tray. For example, an improved catheterization package or kit may be provided to improve ease of use, improve adherence to appropriate techniques, reduce the likelihood of infection, and the like.

According to various embodiments, a medical procedure tray may be included in the medical procedure package. The medical procedure package may also include any other components necessary or useful for a medical procedure. The medical procedure tray(s) contemplated herein may be a single layer tray or have multiple layers. The medical procedure tray(s) can have various shapes and sizes. For example, the medical procedure tray may have a generally or approximately rectangular, square, circular, oval, triangular, hexagonal, polygonal, or other shape. By way of non-limiting example, a generally rectangular medical procedure tray may have a length in the range of 7 inches to 20 inches, a width in the range of 4 inches to 12 inches, and a height in the range of 1 inch to 4 inches. In one embodiment, a generally rectangular medical procedure tray (e.g., similar to the catheterization tray shown in fig. 1-4) may have a length of approximately 11 inches, a width of approximately 8.5 inches, and a height of approximately 2 inches. In one embodiment, a generally rectangular medical procedure tray (e.g., similar to the trays shown in fig. 5, 31A-31C, and 32) may have a length of approximately 14 inches, a width of approximately 8.5 inches, and a height of approximately 2.5 inches.

The medical procedure tray(s) may also include multiple sections of various shapes and sizes, any of which may optionally form a chamber. A portion of the medical procedure tray may be designated for one or more specific uses (e.g., a well for iodine, a portion for storage, etc.), while a chamber may be a portion that is at least partially up to completely separated from one or more other portions, chambers, or combinations thereof by a physical feature such as one or more dividers, etc. The divider may be formed from the medical procedure tray itself (e.g., formed during an injection molding process), and the opposing faces of the divider may not be equal in height if the chamber is separated from other portions or chambers having a higher or lower height base. The divider may be formed separately from the same material as the medical procedure tray or from a different material than the medical procedure tray. The dividers may also be temporarily formed by any one or more other components necessary or useful for the medical procedure until the one or more other components are removed from the medical procedure tray. For example, with respect to the components necessary or useful for catheterization, the one or more dividers may be temporarily formed by a specimen or sample container, instructions/procedures, or other components necessary or useful for catheterization as described herein. As with these portions, the chambers may have a variety of shapes and sizes (e.g., the chambers may be any of the shapes described for the medical procedure tray itself, or other shapes).

According to various embodiments, the medical kit may be a catheterization package including one or more catheterization trays therein. For example, the catheterization package may include a modified catheterization tray that includes a more intuitive or organized layout and/or instructions/program instructions thereon. Although the different features are described below with respect to a catheterization package and/or a catheterization tray, the described features may also be included in or applied to medical packages and/or trays used with procedures other than catheterization.

The catheterization package may include any components necessary or useful for catheterization. Some components useful for catheterization that may be included in a urinary catheterization package include: drainage system, drainage/collection bag, drainage tube, catheter (e.g., Foley catheter), drainage outlet, stabilization device (e.g., c.r.bard., inc.)

Foley stabilization device), a urine meter, a swab or swab stick, a preparation ball (e.g., a cotton wool swab), a forceps, a sample or specimen container, a label that can be filled with details about the sample and adhered to the sample or specimen container, a sterile skin cleanser pack or container (e.g., a povidone iodine solution pack or container), a lubricant pack or container (e.g., a lubricous gel syringe), a sterile liquid syringe (e.g., a 1O cc sterile water syringe for inflating a retention balloon of a Foley catheter), a catheter to be placed in a patientA hole towel on the person, a drape to be placed under the patient's buttocks (e.g., a waterproof absorbent drape), gloves (e.g., a pack of rubber gloves, latex-free gloves), sterile wrap (e.g., CSR wrap), abdominal band (e.g., to hold the sterile wrap in a folded configuration), perineal care pack, hand sanitizing gel (e.g., sanitizing gel hand sanitizer), wet wipes (e.g., a pack of olive soap paper towels), instructions/procedural instructions (e.g., instruction sheet for a health care provider and/or instruction sheet for the patient), safety considerations/procedure checklists, patient information charts, insert sheets, packaging labels, external containers (e.g., sealed bags), and/or other components. The components included in the catheterization package may be included in one or more chambers of the catheterization tray, in a separate bag or pouch (e.g., a bag external to the tray), or in a second catheterization tray.

The catheterization tray(s) may be marked with step-by-step instructions/program instructions arranged at reasonable positions on the tray(s). The catheterization tray(s) may have a layout and design that makes catheterization more intuitive. A single layer catheterization tray, such as that shown in fig. 1-4 and described below, has a generally rectangular shape, includes a plurality of differently shaped chambers, includes step-by-step instructions, and has an improved layout. Other similar single-layer catheterization trays are also shown in fig. 5, 31A-31C, and 32.

According to various embodiments and as shown, for example, in fig. 1-5, a catheterization tray may include: a main chamber 1; a syringe chamber or catheter chamber 2; a swab chamber 3; a small reservoir or overflow chamber 4; and corner storage compartments 5. The tray also includes reinforcing ribs (e.g., reinforcing ribs 20 shown in fig. 2; see also reinforcing ribs 205 in fig. 31A-31C) that help to strengthen the tray and prevent the tray from bending when held (e.g., when held with one hand).

Referring to fig. 1, 2 and 5, the main chamber 1 is the largest chamber in the tray and may contain any number of items for catheterization, such as drainage systems, collection bags, hole towels, pads, inflation syringes and/or gloves. The drainage system, which may be included in the catheterization package and/or in the main chamber 1, may include, for example: drainage/collection bags, drainage tubing, catheters (e.g., Foley catheters), drainage ports, urine meters, and/or other drainage system components. The drainage system components may be pre-connected and stored in a pre-connected state in the catheterization package, or the drainage system components may be stored as separate components to be assembled/connected later.

The drainage system and tubing included in the urinary catheter can be configured and arranged in a manner that helps to improve drainage of urine through the system and tubing. For example, a tube or other component of the drainage system may be designed to break the surface tension of the fluid in order to improve drainage. The drain tube may be shorter to accommodate lower bed attitudes, or may have an adjustable length for beds of various sizes. The tubing or other drainage system components may have a coating (e.g., a lubricious coating) thereon to facilitate drainage therethrough. Optionally, the tubing or other drainage system components may include a superhydrophobic pattern thereon to facilitate drainage.

In addition, there are a range of suitable hardnesses for the tubing or other drainage system components. However, for components (e.g., drainage tubing and/or catheters) that can be coiled in a tray, it is desirable to have tubing stiffness that does not tend to maintain a set shape at room temperature. For example, one may experiment with different hardnesses to ensure that the hardness ultimately used to coil the part does not cause the part to retain the coiled shape when removed from the tray and put into use. For example, it is desirable that the drainage tubing have such a hardness that, despite being packed in the main chamber in a coiled state, the drainage tubing does not remain coiled when connected to a patient, but tends to straighten out to facilitate drainage. The drainage tube may be made of polyvinyl chloride (PVC), silicone, latex, teflon, or another polymeric material.

As shown in figure 1, the

sides

8 and 9 of the tray form two orthogonal inner walls of the main chamber 1 and form corners of the main chamber 1 where the

sides

8 and 9 meet each other. Two additional

internal dividers

10 and 12 separate main chamber 1 from the other chambers. The two

internal dividers

10 and 12 include reduced height sections 14 and 16 (reduced height compared to the full height divider, inner wall or side of the tray).

Furthermore, main chamber 1 includes an internal fillet 18 at the corner formed between the floor of main chamber 1 and its inner wall. Such rounded corners 18 may reinforce the corners of the main chamber 1.

For example, as shown in fig. 1, 2 and 5, the main compartment of the pallet may include instructions/programming and/or other information integrated thereon. For example, the main chamber may include a logo or brand name written thereon, such as "SureStep^TMFoley pallet system "and" BARD ". The main chamber may also or alternatively include instructions/programming relating to catheterization printed or otherwise included thereon. For example, the main chamber may include instructions/programming for how to catheterize a patient, or instructions/programming for steps to be taken after catheterisation. Optionally, the main chamber may include instructions/procedures for appropriate Foley care and maintenance. For example, as shown in fig. 1 and 5, the instructions/program instructions integrated on the main chamber may include an instruction program instruction narrative, "(1) with

Fastening Foley "," (2) placing a urine bag under the bladder "," fastening a tube to a bed sheet with a clip "," (3) recording the date of insertion "," (4) maintaining a red stamp according to hospital policy "," (5) assessing catheter requirements routinely ". The instructions/program instructions or other information may be in uppercase letters, bolded, or otherwise highlighted to enhance visibility to ensure that the clinician reads the instructions/program instructions or other information. Optionally, instructions/procedural instructions may be printed or otherwise included on the main chamber to remind the health care provider/clinician to direct the patient how to properly care for and maintain the catheter after catheterization. Instructions/procedural instructions may be written to help the healthcare provider/clinician remember the important instructions related to the patient that should be given.

The syringe chamber or catheter chamber 2 has an elongate shape and spans about the entire length of the tray. The divider and the inner wall of the tray help to form the syringe chamber or tubing chamber 2. A divider 12 spans between the opposing inner walls of the tray and separates the syringe or catheter chamber 2 from the other chambers, i.e. from the main chamber 1 and from the swab chamber 3. The syringe chamber or catheter chamber 2 is sized and shaped to contain one or more syringes (e.g., a lubricous gel syringe and a sterile liquid syringe for inflating a retention balloon) and/or catheters, such as Foley catheters. For example, a lubricated jelly syringe and a 1O cc sterile water syringe may be packaged in the syringe chamber or catheter chamber 2, but the end user (e.g., a clinician) may remove the syringe during catheterization and place the catheter in the syringe chamber or catheter chamber 2 prior to insertion into a patient (e.g., to facilitate lubrication of the catheter).

A portion of the divider 12 separates the conduit chamber 2 from the main chamber 1. Some dividers 12 have full height (e.g., extending as high as the sides of the tray), but dividers 12 also include reduced height portions 16 and 22 (having a reduced height relative to the full height of the dividers 12, the inner walls, or the sides of the tray). The reduced height portion 16 of divider 12 may act as a gap or opening in the divider that may place the syringe or conduit chamber 2 in fluid communication with main chamber 1, and vice versa. Along the reduced height portion 16, the divider 12 may form a small step between the injector or conduit chamber 2 and the main chamber 1, for example, as shown in fig. 2 and 6 (see also fig. 31A to 31C). The step may also be formed by main chamber 1, which main chamber 1 has a lower/deeper floor than the floor of injector or conduit chamber 2, for example, as shown in fig. 2 and 6 (see also fig. 31A to 31C).

In fig. 1 and 2, another reduced height portion of the divider (i.e., reduced height portion 22) separates the syringe or tubing compartment 2 from the swab compartment 3. The reduced height portion 22 of the divider 12 has a partial or reduced height relative to the entire height of the inner wall or side of the tray. Fig. 5 shows an alternative arrangement of reduced height portions 16, in which both reduced height portions 16 are located along the divider between the injector or conduit chamber and the main chamber (i.e. there is no reduced height portion 22 between the injector or conduit chamber and the swab chamber). Other arrangements and configurations are also possible. If the syringe is packaged or included in the syringe compartment or tubing compartment 2, the reduced height portions (e.g., reduced height portions 16 and 22) facilitate easy removal of the syringe from the syringe compartment or tubing compartment 2 by providing the end user with more open space to reach into the tray and grasp the syringe. This makes removal of the syringe easier than if the divider 12 did not have any reduced height portions and the clinician had to attempt to grasp the syringe in a narrower area.

For example, as shown in fig. 1 and 5, the syringe compartment or catheter compartment of the tray may also include instructions/programming and/or other information integrated thereon. For example, the syringe chamber or catheter chamber may optionally include instructions/programming associated with the catheterization written thereon. As shown in fig. 1 and 5, the instructions/programming integrated on the syringe chamber or catheter chamber may include instructions/programming instructions stating "dispense and lubricate Foley here" (alternatively, the instructions may simply write "lubricate Foley", "dispense lubricant", or the like), "withdraw genitals (non-dominant hand)," prepare the patient with a swab (dominant hand), "insert the catheter and inflate the balloon (dominant hand)". As shown in fig. 1 and 5 and described above, the instructions/program instructions may inform the healthcare provider which hand, e.g., dominant or non-dominant, to use in a given step. The instructions/program instructions or other information may be in uppercase letters, bolded, or otherwise highlighted to enhance visibility to ensure that the clinician reads the instructions/program instructions or other information.

Note that the sides of the catheterization tray may also include instructions/programming or other information thereon. For example, as shown in fig. 1, 2, and 5, side 6 may include an instruction/program instruction 47 of "open iodine" and side 7 may include an instruction/program instruction 49 of "attach water syringe". The instructions/program instructions or other information may be in uppercase letters, bolded, or otherwise highlighted to enhance visibility to ensure that the clinician reads the instructions/program instructions or other information.

As shown in fig. 3 and 4, the base 55 of the syringe chamber or catheter chamber 2 may be offset from the base of all other chambers. In other words, the base 55 of the injector or conduit chamber 2 may not be as deep as, for example, the base 57 of the main chamber 1 or separate from the top of the tray. The bottom/floor of the injector or conduit chamber is offset from the bottom/floor of the other chambers, including the bottom/floor of main chamber 1, due to the offset of substrate 55 from the substrate of the other chambers.

The swab chamber 3 spans along a portion of the tray inner wall along the side 6 of the tray; the portion of the inner wall forms a side of the swab chamber 3. The swab chamber 3 may contain various items, such as a swab or swab stick, and one or more disinfectants, such as iodine (e.g., iodophors, such as povidone iodine, iodine tincture, water iodine, etc.). Portions of divider 10 and divider 12 extend along two other sides of swab chamber 3, forming the other two sides of swab chamber 3, and separating swab chamber 3 from main chamber 1 and syringe chamber or conduit chamber 2, respectively. Further, a small reservoir or spill chamber 4 extends along the fourth side of the swab chamber 3. In one embodiment, for example, as shown in fig. 1 and 2, divider 10 has an overall height that separates swab chamber 3 from main chamber 1, while divider 12 has a reduced height (i.e., at reduced height portion 22) that separates swab chamber 3 from syringe chamber or conduit chamber 2. In one embodiment, for example, as shown in fig. 5, both divider 10 and divider 12 have full height, regardless of whether they separate swab chamber 3 from main chamber 1 and syringe chamber or conduit chamber 2.

The swab chamber 3 has an angled bottom/floor that spans between the small storage or overflow chamber 4 and the syringe or conduit chamber 2 with a downward slope between them (i.e., the bottom/floor of the swab chamber 3 near the conduit chamber 2 is lower than the bottom/floor near the storage chamber 4). Thus, fluid poured into the swab chamber may flow in a direction toward the conduit chamber 2 and pool in the lowest/deepest portion or well 24 of the swab chamber proximate the divider 12 (e.g., proximate the reduced height portion 22 of fig. 1 and 2), where the divider separates the swab chamber 3 from the conduit chamber 2. Similar to the rounded corners 18 in the main chamber 1, rounded corners may be included in the corners of the swab chamber 3, e.g. as shown in fig. 1 and 2.

Fig. 8 shows a larger view of the swab chamber 3 and the adjacent small storage or overflow chamber 4, with the swab or swab stick contained in the swab chamber 3. Near the small storage or overflow chamber 4, the bottom/floor of the swab chamber 3 may be supported by another divider 30 (shown on fig. 2) that separates the small storage or overflow chamber 4 from the swab chamber 3. Also, the divider 30 may extend only up (from the bottom/floor of the small storage or overflow chamber 4) to the bottom/floor of the swab chamber 3, so that the bottom/floor of the swab chamber 3 is unobstructed near the small storage or overflow chamber 4 (thus, a swab or swab stick with a longer stick/rod may extend from the bottom/floor of the swab chamber 3 over a portion of the small storage or overflow chamber 4, such as shown in fig. 8). This design or arrangement also allows the small reservoir or overflow chamber 4 to act as an overflow well in the event that excess fluid/iodine is poured into the swab chamber 3.

The swab chamber 3 includes one or more channels 28 extending at least partially along the area between the mini-reservoir or flood chamber 4 and the well 24 at the bottom/floor of the swab chamber 3. On the side of the swab chamber 3 adjacent to the conduit chamber 2, the channel 28 extends to and is in fluid communication with the lowest/deepest part of the well 24 adjacent to the divider 12, so that liquid poured into the channel(s) 28 can flow down the channel(s) 28 along a downward slope and collect in the lowest/deepest part of the well 24. The channel(s) 28 may be designed to hold elongated devices (e.g., swabs or swab sticks), and each channel 28 may be separated by one or more barriers 26 to help space the elongated devices (e.g., swabs or swab sticks) apart. The channel(s) 28 may also include an undercut or snap feature 32 (e.g., snap tabs) that may aid in securing an elongated device, such as a swab, a swab bar, or a swab bar, in the channel 28.

For example, as shown in fig. 1, 5, and 8, the swab chamber of the tray may also include instructions/program instructions and/or other information integrated thereon. For example, the swab chamber (e.g., on one of the barriers 26) may optionally include instructions/program instructions related to catheterization printed or otherwise included thereon. As shown in fig. 1, 5, and 8, the instructions/program instructions integrated on the swab chamber may include instructions/program instructions that recite "pour iodine herein". The instructions/program instructions or other information may be in uppercase letters, bolded, or otherwise highlighted to enhance visibility to ensure that the clinician reads the instructions/program instructions or other information.

One or more swabs or swab sticks (e.g., the swab or swab stick 34 shown in fig. 6A-8) may be packaged in the swab chamber 3 and retained in the channel 28 (e.g., as shown in fig. 8). The swab or swab wand may be specifically designed to fit within the swab chamber 3 and remain within the channel 28. The wipe chamber 3 may also include iodine or povidone-iodine solution. The iodine or povidone-iodine solution may be packaged in the swab chamber 3 in its own container, pack, or syringe, such as the povidone-iodine pack 52 shown in fig. 26. Alternatively, the iodine or povidone-iodine solution may be stored and/or sealed in the swab chamber 3 in direct contact with the swab(s) or swab stick(s) 34 (e.g., packaged/sealed in contact with a portion of the bottom/floor of the swab chamber 3).

Fig. 6A-6C show one embodiment of a swab or swab stick 34 having an elongated member or stick/rod 38 with rounded sides (e.g., cross-section) that is more rounded than the swab or swab stick 34 shown in fig. 7A-7C. Fig. 7A-7C show one embodiment of a swab or swab stick 34 having an elongated member or rod/stem 38, the swab or swab stick 34 having non-round or more angled sides than the swab or swab stick 34 shown in fig. 6A-6C. As shown in fig. 6A-7C, the swab or swab stick 34 represents other possible swabs or swab sticks that may be included. The swab or swab wand 34 includes an absorbent head 36 and an elongated member or wand/rod 38. The absorbent head 36 is designed to allow for greater saturation (saturation) in the cleaning solution (e.g., iodine or povidone-iodine solution) and to allow for greater contact with the surface area of the area to be cleaned. The absorbent head 36 may be formed from a variety of materials, including foam, rayon (e.g., a puff of rayon or a spiral of rayon), cotton, other materials, and/or combinations of one or more of these materials. To improve the saturation of the absorbent head, the absorbent head 36 is desirably made of a material that readily absorbs and dispenses cleaning solution. Any material that absorbs a significant portion of its weight in the cleaning solution is desirable for use in the absorbent head, particularly if it also releases a significant portion of the absorbed cleaning solution, i.e., it is desirable to use a material that absorbs a significant amount of the cleaning solution and also releases a significant amount of the cleaning solution when used to clean a patient. It has been found that a foam-forming (as opposed to rayon or other material) absorbent head 36 provides improved cleaning solution absorption and cleaning solution saturation for the absorbent head 36. Further, when the foam absorbing head is in contact with the area to be cleaned of the patient, and when the foam absorbing head is slightly pressed against the area to be cleaned, the foam absorbing head easily releases a large amount of the cleaning solution. This easy release of the cleansing solution makes it easier to clean the area of the patient and allows the end user to be more gentle when cleaning the patient. If the absorbent head 36 is made entirely or partially of foam, the foam may be open cell foam, closed cell foam, polyurethane foam, high density foam, latex foam, honey gold foam, or other types of foam. The absorbent head may be heated to bond it to the elongated member or rod (e.g., the foam may be heated to bond to the rod), or other attachment means may be used, such as the use of an adhesive.

Preferably, the foam or other material(s) selected for the absorbent head will not degrade or at least resist degradation when in contact with the cleaning solution. In one embodiment, the swab or swab stick may be stored in contact with iodine or povidone-iodine solution, and therefore become saturated when they are first accessed in a catheterization package. For example, a seal may be placed in or over the swab chamber 3 that keeps the cleaning solution in contact with the swab(s) or the absorbent head(s) of the swab stick before the seal is removed, while preventing leakage. It is critical that the absorbent head not degrade over time when packaged and stored in contact with the cleaning solution. For example, honey gold foam has sufficient resistance to degradation when contacted with iodine or povidone-iodine solutions.

The absorbent head 36 can have a variety of sizes and shapes. Preferably, the foam is shaped in a manner so as to provide greater contact with the surface area of the area to be cleaned. For example, the absorbent head 36 may be shaped such that the distal or distal end region (e.g., the region in contact with the patient) is substantially larger than the region that is less likely to be in contact with the patient (e.g., the proximal end or where the absorbent head 36 is attached to the elongate member or rod 38). This provides a greater surface area at the patient contacting end of the absorbent head and makes cleaning the patient faster and easier. Further, as the distal region of the absorbent head becomes larger, most of the iodine is absorbed into the region that contacts the patient (conversely, when the largest region of the absorbent head is not at or near the distal end, most of the iodine is wastefully absorbed into the location that does not contact or clean the patient). The absorbent head 36 may be shaped as shown in fig. 6A-7B and may be wider than it is thick. The absorbent head 36 may also be shaped to be generally or approximately circular, rectangular, or trapezoidal. Alternatively, the shape of the absorbent head 36 may be generally or approximately conical, pyramidal, teardrop, oval or triangular (with the larger bottom end located at the distal end of the swab or swab stick), or may be another shape. If generally pyramidal in shape, the base of the pyramidal shape may be generally triangular, square, pentagonal, hexagonal, etc. Even if generally conical, pyramidal, or another shape, the edge of the absorbent tip at the distal end may be curved or tapered (e.g., the distal edge is curved as in fig. 6A-7B). Further, the distal end of the elongated member or wand 38 may also be curved (e.g., the distal end may be semi-circular rather than flat across the top or distal-most edge) because the curvature is less likely to harm the patient when cleaning with a swab or swab wand.

In one embodiment, the absorbent head may be between 0.5 inches and 2 inches in length (in one embodiment, the length may be approximately 1 inch), the absorbent head may be between 0.5 inches and 2 inches in width at its widest point (in one embodiment, the width at its widest point may be approximately 1 inch), and the absorbent head may be between 0.1 inches and 1 inch in width at its narrowest point (in one embodiment, the width at its narrowest point may be approximately 1/2 inches). Further, if the absorbent head shape is not generally conical or pyramidal (i.e., such that its surrounding width and thickness are the same), it may have a thickness that is less than its width, such as a thickness between 0.1 inch and 1 inch (in one embodiment, the thickness may be approximately 3/8 inches).

In one embodiment, the elongated member or rod 38 may have a length of between 2 inches and 7 inches (e.g., the elongated member or rod 38 may have a length of between 3.5 inches and 4.5 inches, or approximately 4.25 inches). The length of penetration of the rod 38 into the absorbent head 36 (i.e., the length of the rod 38 extending distally beyond the proximal end of the absorbent head) may be between 0.25 inches and 1 inch (e.g., the penetration length may be approximately 0.5 inches). It is preferable to ensure that the penetration length is within a good range with respect to the total length of the absorbent head. If the wand 38 extends too far into the absorbent head 36, the patient's skin may be too easily damaged by the wand 38 (e.g., the patient may be more easily scratched during cleaning, and may not be adequately packed with foam). However, if the wand 38 does not extend far enough into the absorbent head 36, the absorbent head 36 will lack structure and fall around (especially if saturated with liquid), which makes it more difficult for the end user to guide the swab or swab wand absorbent head and effectively clean the patient. Desirably, the penetration length of the rod 38 will extend between 35% and 70% of the length of the absorbent head 36 (e.g., the penetration length may be about 50% of the length of the absorbent head). The elongated member or rod 38 may be formed from a variety of materials, including plastic or polymeric materials.

The elongated member or rod 38 may have a variety of different cross-sectional sizes and shapes. For example, the swab or swab stick may be biased to be relatively flat or have a generally rectangular cross-section (or a rectangular-like cross-section, but with rounded edges, such as shown in fig. 6C, or with cut edges, such as shown in fig. 7C), and thus be easier to hold. The elongated member or rod 38 shown in fig. 6A-6C has rounded edges, but otherwise has a generally rectangular shape. This shape is easier to hold and manipulate when cleaning a patient than a rod with a circular cross-section. Further, this and similar cross-sectional shapes of the elongated member or wand 38 make it possible for the swab or swab wand to be snapped into the tray or held under the feature 32 to prevent the swab or swab wand from moving during transport or prior to use. To remove a swab or swab stick having this cross-section, the elongated member or stick 38 may simply be twisted in a clockwise or counterclockwise direction, and the feature 32 easily releases the swab or swab stick for use. For example, fig. 8 shows two swabs or swab sticks that snap into or remain in place under the feature 32, and also shows one swab or swab stick that has been twisted so that the feature 32 no longer holds the swab stick or prevents its removal. This not only makes the swab or swab stick very secure in the swab chamber 3 during transport and before use, but also makes removal of the swab or swab stick during catheterization very simple and easy.

In one embodiment, if the elongated member or rod has a generally flat (e.g., generally rectangular) shape, the width or diameter of the elongated member or rod 38 may be between approximately 1/8 inches and 3/4 inches (e.g., the width may be approximately 1/4 inches) and the thickness may be between 1/16 inches and 1/2 inches (e.g., the thickness may be approximately 1/8 inches). If the elongated member or rod has a generally circular cross-section or is generally cylindrical in shape, the diameter of the elongated member or rod 38 may be between 1/8 inches and 1/2 inches (e.g., the diameter may be about 1/4 inches).

The swabs or swab sticks are loaded into the tray and held in such a way that the absorbent heads 36 are located in the lowest/deepest portion or well 24 at the bottom of the swab chamber 3 so that they are exposed to the iodine that collects in the lowest/deepest portion or well 24 at the bottom of the swab chamber 3 and are readily saturated with iodine or povidone-iodine solution. However, the elongated member or wand 38 may be loaded into the tray and held in such a way that the elongated member or wand 38 itself is not exposed to the iodine or povidone-iodine solution.

The small reservoir or overflow chamber 4 spans along a portion of the side 6 of the tray that forms the inner wall of the tray and the side of the small reservoir or overflow chamber 4. The other three sides of the mini-reservoir or overflow chamber 4 are formed by partial height dividers that separate the mini-reservoir or overflow chamber 4 from the main chamber 1, swab chamber 3 and corner chambers 5. These chambers may surround three sides of the small reservoir or overflow chamber 4. A small reservoir or overflow chamber 4 may act as an overflow well to collect any fluid overflowing from the swab chamber. Optionally, the mini-reservoir or overflow chamber 4 may store or hold one or more items useful for catheterization.

For example, as shown in fig. 1 and 5, the mini-reservoir or overflow compartment of the tray may also include instructions/programming and/or other information integrated thereon. For example, the mini-reservoir or overflow chamber may optionally include instructions/programming relating to the catheterization printed or otherwise included thereon. As shown in fig. 1 and 5, the information integrated on the small storage or overflow chamber may include a reminder that the healthcare provider/clinician should "refer to instructions for use to get a complete description". The instructions/program instructions or other information may be in uppercase letters, bolded, or otherwise highlighted to enhance visibility to ensure that the clinician reads the instructions/program instructions or other information.

The corner storage compartments 5 span along portions of the

sides

6 and 9 of the tray, which form the sides and corners of the corner storage compartments 5. The other two sides of the corner storage chamber 5 may be formed by partial height dividers that separate the corner storage chamber 5 from the main chamber 1 (e.g., reduced height section 14) from the mini-storage or overflow chamber 4. These chambers surround both sides of the corner storage chamber 5.

The bottom/floor of the corner storage compartment 5 may be non-planar; that is, the base/floor may have a non-planar, rounded or partially cylindrical shape. This shape may be particularly useful for holding a specimen or sample container. The corner storage compartment may store or hold various implements for catheterization. For example, the corner storage chambers may hold labels that may be filled out by a clinician on a first side and adhered to a specimen or sample container on a second side. The second side may already include an adhesive thereon; the adhesive may be covered by a removable cover sheet which may be removed upon adhesion. The corner storage chamber may also include a specimen or sample container 54.

In one embodiment, at least some of the chambers may be sealed in a manner that prevents contamination. In one embodiment, at least one chamber can be unsealed independently of at least one other chamber. For example, the user may first unseal the main chamber, leaving the other chambers sealed. After using the items contained in the main chamber, the user can decrypt the other chamber and use the items contained in the chamber.

In one embodiment, the user may decrypt the sealed sub-chamber 3 before decrypting the sealed syringe chamber or catheter chamber 2 or main chamber 1. The user may pour iodine or another disinfecting solution into the swab chamber, and may apply the disinfecting solution to the swab using the swab chamber and clean the patient using the iodine soaked swab. The user can then decrypt the syringe chamber or catheter chamber 2 and dispense lubricant therein before decrypting the sealed main chamber 1. The user can then unseal the main chamber 1 to access the conduit. The shape and size of the catheter chamber facilitates lubrication of the catheter (e.g., the tip of the catheter may rotate within the elongated shape of the catheter chamber and collect lubricant on its surface during rotation). The catheter may be lubricated in the syringe chamber or catheter chamber 2 and then inserted into the patient's urethra.

According to various embodiments, and as shown in fig. 1, 2 and 5 and discussed above, the tray may have ordered, step-by-step instructions/procedures thereon for suitable or preferred catheterization techniques.

Other aspects or features of the urinary bag(s) and tray(s) are also described below in the context of non-limiting procedures or methods of using the urinary bag and tray, as well as in the context of manufacturing or packaging the urinary bag. The aspects or features described below may be incorporated into the various implementations already discussed above. The arrangement of the components and how they are accessed is part of the overall intuitive design of the catheterization package, i.e., the components and features are arranged in a logical fashion with a stepwise flow to make the catheterization more intuitive and to make the procedure easier and/or faster to complete. The stepwise ordering of the components in the catheterization package helps the user/clinician logically know what to do next. For example, a first item may be revealed in the package, and then once the first item is used, a second item underneath the first item, which is the next logical item to be used in the catheterization, is revealed. Once the second item is used, a third item may be revealed underneath the second item, the third item being the next logical item to be used in the catheterization, and so on.

The catheterization package(s) and catheterization tray(s) described herein may be used in many different ways. Non-limiting methods of use are described below. However, the clinician may change the steps or procedures described herein, may reorder the steps, may perform additional steps in addition to those described, and/or may omit certain steps depending on the circumstances and the unique needs of the patient. Further, the following description may be considered a description of an entire procedure having many steps, or may be considered a series of separate methods or procedures, each including only a subset of the described steps.

First, a catheterization package such as that illustrated in fig. 9 and 10 may be provided (e.g., the health care provider/clinician may obtain or select the catheterization package from a shelf or through purchase, or may place the catheterization package in a patient's room awaiting catheterization). As seen in fig. 9 and 10, the urinary catheter package may be sealed, for example, by an outer container 60 (e.g., a sealed bag) surrounding the other contents of the urinary catheter package, such that the contents remain sterile and are properly contained. A paper or cardboard packaging label 62 may be included in the urethral catheterization package just inside the sealed bag (or other outer container). The outer container 60 (or sealed bag) may be transparent, or at least partially transparent, so that the label 62 or portions of the label may be visible to the clinician. The labels 62 may include foldable sides 64 so that they extend down the sides of the urinary catheter package. The label may comprise one, two, three or four sides. For example, fig. 11 and 12 each show a label 62: a

larger top

66, and 3 smaller sides or sides 64 that can be folded to a different plane than the plane in which the larger top 66 lies. The lines on fig. 12 show the locations where folds can be made to form sides or side portions. In one embodiment, the label has four sides or sides 64 instead of three.

Packaging label 62 may include instructions and or other information thereon. For example, the label 62 may include an initial description for the catheterization. Label 62 may include a logo, trademark, or product name printed or otherwise included thereon, such as "SureStep^TMFoley tray System'

I.C.Complete

"and/or" BARD ". The label 62 may also or alternatively include instructions written thereon relating to catheterization. For example, the label may include the instruction(s) 40 to verify that the patient is in compliance with CDC guidelines for use of an indwelling urethral catheter, as shown in the lower left quadrant of the top portion 66 of the label 62 in fig. 9-12. The label may include a manifest 41 to qualify the patient for different factors for indwelling urethral catheter use according to CDC guidelines, for example, also as shown in the lower left quadrant of the top portion 66 of the label 62 shown in fig. 9-12. The label 62 may also include a list of components 42 of the urinary catheter, as shown on the right side of the top portion 66 of the label 62 in fig. 9-12. The directions or other information may be in capital letters, bold, or otherwise highlighted to enhance visibility to ensure that the clinician reads the directions or other information.

Packaging label 62 may also include key information or variables highlighted in a manner that is simplified and easy to read. For example, visual identifiers, squares, other shapes, and/or other features may be included, all with an indication of a piece of key information or variable being highlighted and easily read. In fig. 9-12, the label 62 is shown to include information blocks 44, each of which includes an indication of a piece of critical information about the urinary catheter. The information block 44 essentially separates and characterizes the information specific to the catheterization tray from a range of possibilities or variables. Various features or variables may be highlighted, including: (1) whether the tray includes a drainage bag or urine meter, (2) French size of the catheter, (3) type of catheter included, (4) type of backing of materials used in the catheter or other components, e.g. latex or latex-free, (5) special components orFeatures, e.g. comprising

Fastening devices, including special infection control coatings or other features. This highlighting of a particular variable (separate from all other variables) allows the health care provider to see the contents of the catheterization package or tray at a glance. Thus, the health care provider can quickly determine what the key distinguishing elements of the urinary catheterization package or tray are. For example, if the FIG. 9 and FIG. 10 urinary catheterization packages are both stored on the same shelf, the healthcare provider can quickly discern the primary differences between the urinary catheterization packages simply by looking at the information block 44. As can be readily seen from the information block 44 in FIG. 9, the catheterization package in FIG. 9 includes an 18 French size catheter, a drainage bag, Bard

And is a non-latex catheter. As can be readily seen from the information block 44 in FIG. 10, the catheterization package in FIG. 10 includes a 16 French size catheter, a drainage bag and a Bard

Further, packaging label 62 may be designed to be visible in multiple planes. The label may be designed to be folded at the edge of the urinary catheter, such that the label (or a portion of the label) forms a side or side portion, which is visible from the side in addition to the top when the urinary catheter is viewed from the side. In fig. 9-12, the label 62 is designed so that the information block 44 is visible from the top of the urinary catheter and at least two sides of the tray. Alternatively, the label may also be designed so that the information patch 44 appears on all sides of the urinary catheter package (e.g., three sides or four sides). Thus, the label is visible regardless of how the urisheath is stored. Further, multiple catheterization packages may be stacked on top of each other, but due to the information squares on one or more sides of the catheterization packages, the clinician may still quickly discern from the sides of the packages in the stack which catheterization package in the stack is the one intended for the particular patient.

The catheterization package may be selected based on the information block 44, for example, after reviewing the information block 44. After providing/obtaining/selecting the catheterization package, the user may open the container (e.g., sealed bag) and remove it from around the remainder of the catheterization package. After the container (or sealed bag) has been removed, the remainder of the catheterization package appears, for example, as shown in fig. 11.

The user may then remove the label 62 and put it aside to reveal other components underneath the label 62. For example, when the label is removed from the catheterization package shown in fig. 9-11, a catheterization specification or use instruction file 68 for the catheterization package or tray may be revealed, for example, as shown in fig. 13. Thus, the specification and/or information regarding security considerations is one of the first accessed items in the catheterization package. The detailed description provided in advance allows the user/clinician/healthcare provider to review the entire procedure prior to any other steps and prior to breaking the sterile field formed by the CSR wrap surrounding the catheterization tray. This helps the program to run more efficiently and safely. The pages of the specification can be seen on multiple pages of the document 68 in fig. 14A-14D. Any one or more of the steps contained in fig. 14A to 14D may be executed as a catheterization method or program.

In addition, there may be associated patient educational information, whether enclosed in the specification or separately placed in the catheterization package. The healthcare provider may use the patient educational information to guide the patient through the indwelling catheter, and may ultimately be provided to the patient for reference. Fig. 15A and 15B illustrate an embodiment of patient educational information on a patient sheet/book 70 that may be included in the catheterization tray. Fig. 15A shows a first side of the patient educational information sheet 70 in english, and fig. 15B shows a second side of the patient educational information sheet 70 in spanish.

Below the specification or use specification, the catheterization package may include a list of safety considerations/steps, a patient information chart, or an insert sheet including safety considerations/steps and a patient information chart combined on the same insert sheet. Fig. 16 shows an insert sheet 72 on which patient information may be recorded or graphed and includes safety information. The insert sheet 72 may be accessed after the specification is removed from the package. It may be beneficial to have the insertion sheet 72 in this position so that the last safety check is made before the patient is treated and important patient information is available on hand. The insert sheet 72 may be configured as a sticker label, for example, the insert sheet 72 may include a backing that protects the sticker adhesive, and when the backing is removed, the insert sheet 72 may be affixed to a file or chart associated with the patient.

After the specification 68 and insert sheet 72 are removed from the catheterization package, a perineal care (or perineal care) package or kit 74 (as shown in fig. 17 and 18) is exposed and can be accessed. The perineal care kit helps provide initial cleaning of the area for catheterization before further cleaning and disinfecting the area with an iodine solution. This is especially true for patients who are very dirty and must be initially cleaned before the iodine solution will be most effective. The perineal care kit can generally include any article that facilitates initial cleaning or perineal care of the patient's perineum. For example, as shown in fig. 18 and 19, the perineal care kit may include a hand sanitizing gel 76 (e.g., a sanitizing gel hand cleanser) for sanitizing his/her hands by the healthcare provider, a wet wipe 78 (e.g., a pack of olive soap wipes), instructions/program instructions 80 (e.g., instructions/program instructions for the healthcare provider and/or instructions for the patient). The hand sanitizing gel can be designed to have improved efficacy and/or be capable of single-handed use.

As shown in fig. 17-19, the articles of the perineal care kit may be included in a bag 82 (e.g., zip-lock bag) or other bag to hold the articles/components together. In one embodiment, the type of bag used is a bag that includes a zipper 84. It has been found that this type of pouch is easier to open with gloves than, for example, a pouch without a zipper or a pouch that must be opened by tearing. However, bags having perforations on the bag rather than zippers or zip-lock features are also contemplated, as such bags would be less expensive to manufacture.

A perineal care instructions/procedure indication 80 is shown in fig. 17-19. The instructions 80 may inform the health care provider to: "1. wash hands and don gloves", "2. explain the procedure to the patient and open the perineal care kit", "3. clean the periurethral area of the patient using the supplied paper towel pack", and "remove gloves, perform hand hygiene with the supplied alcohol hand sanitizer gel". Other specifications/program instructions are also possible. The method may include performing some or all of the four steps described above as illustrative steps.

The method can be carried out in three main phases, namely (a) an initial perineal care phase, (B) a catheterization phase, and (C) a catheter care and maintenance phase. Each of these stages is represented by a large "a", "B" or "C" on the description/procedural instructions and/or other materials to indicate a different primary stage. As can be seen on the perineal care instructions 80, there is a large "a" on top of the instructions/procedure instructions to indicate the first stage. As discussed elsewhere herein, the abdominal belt 46 includes a large "B" to indicate the second stage, and the main chamber 1 of the catheterization tray includes a large "C" to indicate the third stage.

After removal and use of the perineal care kit, the binder/indicator wrap 46 (see also indicator wrap 140 in fig. 30B) can be revealed as shown in fig. 20. The abdominal belt 46 may encircle the tray in at least one direction. The abdominal band 46 may help keep the CSR wrap intact and maintain a sterile barrier. The webbing 46 may also help to retain all of the contents inside the tray so that the items do not move around.

Instructions/program instructions and/or other information may be included on the binder/indicator wrap 46. For example, as shown in fig. 20 (see also fig. 30B), the abdominal belt may include instructions/programming that tell the health care provider how to orient the tray relative to the patient. For example, the abdominal belt may be written "oriented towards the insertion site" and have an arrow pointing towards the end of the urinary catheterization tray that should be positioned closest to the perineum and urinary tract of the patient. This ensures that the tray is positioned most properly for the most logical and intuitive use when opening the CSR wrap.

Further, as shown in fig. 20 (see also indicator wrap 140 in fig. 30B), abdominal belt 46 may include instructions/program instructions to "use appropriate aseptic technique", "(1) open CSR wrap", "(2) put on sterile gloves", "(3) place dunnage", "(4) place hole towel", and (5) "follow the tray instructions". These instructions/program instructions include a large "B" on the top to indicate that the instructions/program instructions are part of the second or catheterization stage. The instructions/program instructions inform the health care provider to open the CSR wrapper, and perform other steps upon opening the CSR wrapper. Providing this information prior to breaking the sterile barrier allows the healthcare provider to preview the procedure and ensure that he/she is ready when the sterile barrier is broken by opening the CSR wrap. Alternatively, a label or sticker may be used in place of the abdominal band, which may provide the same information as the abdominal band described herein.

Once the tray is oriented and the health care provider has read the binder description/program instructions, the next step is to open and/or remove the binder. After removal of the abdominal band, the sterile wrap 56 (e.g., CSR wrap) may be opened. Fig. 21 shows a catheterization tray with three corners of the sterile wrap 56 unfolded to represent the unfolding of the sterile wrap 56. Note that the sterility barrier of the catheterization tray and its components is not breached until the abdominal band and sterile wrap are opened. This maintains a sterile barrier at the completion of the initial perineal care phase and when the tray is properly positioned and oriented for catheterization. By keeping the sterile barrier intact during the initial steps of the method, the chances of contamination and resulting infection of the patient are reduced.

If the catheterization tray is oriented as indicated by the abdominal belt 46, the tray is properly oriented when the sterile wrap 56 (e.g., CSR wrap) is opened for reasonable and convenient use of the catheterization tray and its components. As described herein, the trays are arranged and ordered for logical step-by-step use. Fig. 22 shows an initial view of the tray after sterile wrap 56 has been fully opened. (a break line is used to indicate that the actual edge of the sterile wrap 56 extends beyond the break edge shown in fig. 22-29.) note that the sterile wrap 56 may remain underneath the catheterization tray to form a sterile field for catheterization. The tray shown in fig. 22 and other figures is biased toward a right-handed person for easier use by a right-handed healthcare provider when standing near the lower edge of the catheterization tray with the syringe chamber or catheter chamber positioned furthest away from the healthcare provider (i.e., if the abdominal band is directed toward the genitals between the legs, the right-handed person stands on the side closest to the patient's right leg). Alternatively, the catheterization tray may be left-handed (e.g., substantially a mirror image of the tray shown in fig. 22-29 with the reflector placed along the tray side 7 or along the syringe chamber or catheter chamber).

As indicated on the abdominal band 46, after first opening the CSR wrap, the health care provider then takes the sterile gloves provided in the tray. As shown in fig. 22, the top item in the tray after the CSR wrap is opened is a sterile glove pack 58 (note that the cuff end of the glove may be indicated on the pack 58). The sterile gloves may be made of any material known to be suitable, for example, latex, rubber, or latex-free materials. Placing the gloves on top of the tray under the sterile wrap helps the healthcare provider intuitively know that he/she should don the gloves before proceeding further (because this is intuitive, it may not be necessary to refer back to instructions/program instructions on the abdominal belt 46). The glove bag 58 can be opened by folding the cuff down to the nearest health care provider and then opening the package like a book, as shown in fig. 23. If opened in this intuitive, logical manner, the left-hand glove is located on the left side of the healthcare provider and the right-hand glove is located on the right side of the healthcare provider for easy donning of the gloves. Symbols or other indications may be included on the bag 58 to identify the left and right hand gloves, such as shown in fig. 23.

After wearing the gloves, the healthcare provider places the drape under the patient's buttocks, as indicated on the abdominal belt 46. As shown in fig. 24, once the glove package is removed from the tray, the drape and hole towel are revealed. The folded single/hole towel 86 shown in fig. 24 represents: (1) a waterproof sheet, and (2) a separate hole towel. The sheet may have a waterproof side and a liquid-absorbing side. If so, the absorbent side is placed under the patient and the waterproof (or plastic) side is placed under. As indicated on the abdominal belt 46, after placement of the padding, the health care provider places a hole towel over the patient so that the genitals are visible through the central opening in the hole towel. Although fig. 24 does not show the drape and hole towel as distinct pieces, both are included in the area of the drape/hole towel 86 and are arranged such that the drape is on top of the hole towel (i.e., the hole towel is revealed for subsequent placement as the drape is placed first). The hole towel is logically positioned and folded so that it is intuitive to open the hole towel away from the clinician, which is preferable for how best to use the hole towel.

As indicated on the abdominal belt 46, after placement of the hole towel, the health care provider follows the instructions/procedures and/or proceeds with the steps written on the catheterization tray itself. As shown in fig. 25, removal of the drape and the hole towel reveals a sterile solution pack 52 (e.g., povidone-iodine solution). (note that fig. 25 shows a hole towel moving from above swab chamber 3 into main chamber 1. moving the hole towel in this manner or placing the hole towel on the patient will reveal the disinfecting solution in the swab chamber.) further, a first instruction/program instruction 47 on the tray (i.e., "(1) open iodine"; but this or other instructions may vary) is visible on the left side of the tray (which is also the side closest to the patient and the area to be catheterized, if oriented as indicated by abdominal belt 46). Placing the first description 47 to the left is logical in that people read english from left to right, and the beginning description to the left is intuitive (but this can be adjusted in countries that do not read from left to right). Furthermore, the instructions/program instructions are located in the tray near the sanitizing or iodine solution 52, which makes it easier and more intuitive to follow the instructions/program instructions.

Assuming that the clinician is right-handed and has oriented the tray as indicated by the abdominal belt 46, the antiseptic or iodine solution 52 is automatically positioned proximate the patient. (however, as discussed above, another arrangement is possible in which the tray is biased toward the left-handed person (e.g., substantially a mirror image of the tray in the figure) such that positioning the tray as instructed by the binder by the left-handed user will also automatically position the antiseptic or iodine solution in a position closest to the patient (e.g., the left-handed clinician stands on the opposite side of the tray from the position of the right-handed clinician stand or on the side closest to the left leg of the patient)). Placing the disinfectant or iodine solution (and swab chamber) in the closest proximity to the patient is preferred for use of the tray. It is beneficial to have the swab chamber 3 and iodine solution well in close proximity to the patient because it prevents the swab saturated with disinfectant or iodine solution from being dragged or moved across the tray (if moved over other components of the tray, they may drip onto other components of the tray).

Fig. 26 shows the catheterization tray after removal of the povidone-iodine solution. Note that the sterile or iodine solution pack 52 is removed, revealing the swab or swab stick 34 and the second instructions/program instructions 48 on the tray. This intuitively results in the health care provider logically following the second instructions 48 after picking up the package of antiseptic or iodine solution. The second instructions 48 on the tray are in the swab chamber 3 and write "(2) pour iodine here >" and point to the lowest/deepest point or well of the swab chamber 3 (although this or other instructions may vary). If the disinfectant or iodine solution is poured onto the barrier or channel of the swab chamber 3, the bevel ensures that the solution will flow to the lowest/deepest point or well.

Once the health care provider has poured the disinfectant or iodine solution into the well of swab chamber 3 such that the absorbent head of the swab begins to absorb the disinfectant or iodine solution, the health care provider may then attach sterile liquid syringe 88 to the inflation port of catheter 92 (e.g., Foley catheter) as indicated by third instructions/procedure instructions 49. The third description 49 is logically located on the side 7 of the tray, not far from the well of the swab chamber where the health care provider has just poured the disinfectant or iodine solution, and near the sterile liquid injector to be used in the third description. The third description 49 writes "(3) attach water injector" (although this description or other description/program instructions may vary). Fig. 27 shows a sterile liquid or water syringe 88 that has been attached to the inflation port of the catheter 92.

Once the sterile liquid syringe 88 is removed from the syringe chamber or catheter chamber, the fourth instructions/program instructions 50 (which were previously obscured by the sterile liquid syringe) are revealed. The fourth instruction 50 may inform the healthcare provider "(4) to lubricate the catheter" or "(4) to dispense and lubricate Foley" or similar text herein (again, this instruction or other instructions/program instructions may vary). Indeed, lubricating the catheter is the next step that the health care provider takes. To this end, the healthcare provider removes the lube gel injector 89, which reveals the fifth, sixth, and seventh instructions/program instructions that were previously obscured by the lube gel injector 89. The lubricating jelly may be provided in other suitable containers known to those of ordinary skill in the art in light of the present disclosure, including, by way of non-limiting example, bellows, ampoules, and the like. The health care provider may then lubricate the catheter in any desired manner. In one embodiment, the health care provider may remove the plastic wrap 90 (shown in fig. 27 and 28) from over the catheter 92 (which may be a Foley catheter) and move a portion of the catheter 92 into the syringe chamber or catheter chamber 2, such as shown in fig. 28. Placing the distal end 94 of the Foley catheter 92 in the syringe chamber or catheter chamber 2 helps to align the catheter 92 for lubrication and catheterization. For example, as shown in fig. 28, when the distal end 94 of the catheter 92 is located near the left-most side of the injector room or catheter room 2, the distal end 94 of the catheter 92 is located very close to the patient and the area to be catheterized (assuming the tray has been oriented as indicated by the abdominal band 46). Further, the distal end of the catheter 92 is positioned such that it is directed substantially toward the area to be catheterized, such that the health care provider can simply lift the catheter 92 and move it a short distance in the direction in which it is directed to begin inserting the catheter 92 into the patient. Once the catheter 92 is positioned in the syringe compartment or catheter compartment 2, the user may dispense the lubricating jelly from the syringe 89 into the syringe compartment or catheter compartment 2, onto the distal portion of the catheter 92 (e.g., the syringe may be dispensed on the left side of the syringe compartment or catheter compartment, near the patient and the area to be catheterized), and thread the catheter 92 into the lubricating jelly to ensure that it is properly lubricated.

Although the above-described lubrication method is beneficial for the reasons described above, other methods of lubricating the conduit 92 are possible. In one embodiment, the health care provider may dispense a lubricating jelly onto a portion of the sterile/CSR wrap surrounding the tray and place the tip of the catheter into the lubricating jelly for lubrication. In one embodiment, the user may dispense the lubricous gel directly into the syringe chamber or catheter chamber 2 prior to moving the catheter 92 from the main chamber 1 and then move the distal portion of the catheter 92 into the lubricous gel.

After lubricating the catheter 92, the health care provider may leave the catheter 92 temporarily in the syringe and catheter chamber 2 while he/she uses his/her hands free to withdraw the genitalia and use his/her hands to prepare and disinfect the patient with a swab or swab stick saturated with a disinfecting or iodine solution. The swab or swab stick (e.g., the swab or swab stick 34 having the absorbent head 36 and the stick 38 as described above) may be twisted clockwise or counterclockwise to easily release them from the channel of the swab chamber as described above. Preferably, each swab or swab stick will be used for only one wipe of the patient. For female patients, the patient may be cleaned by: (1) wiping down with a swab or swab stick to clean the right labia minora and discarding the swab or swab stick; (2) wiping down with another swab or swab stick to clean the left labia minora and discarding the swab or swab stick; and (3) cleaning the intermediate region between the labia minora with a third swab or swab stick. For male patients, the swab or swab stick may be used to cleanse the patient by moving a circular motion outward from the urethral opening. After the patient is prepared and sterilized in this manner, the healthcare provider uses his/her hands-in-use to insert the catheter into the patient's bladder (as the catheter enters the bladder, urine becomes visible in the tubing, but should be inserted two more inches beyond this point to allow the retention balloon to enter the bladder), and to inflate the retention balloon in the bladder by injecting sterile liquid from the sterile liquid syringe 88 through the inflation port into the catheter 92. In fact, these steps are indicated in the fifth, sixth and seventh steps, respectively, on the pallet, which respectively write: "(5) retrieve genitalia (non-dominant hand)", "(6) prepare patient with swab (dominant hand)" and "(7) insert catheter and inflate balloon (dominant hand)". These descriptions/program instructions or other descriptions/program instructions may vary. Once inflated, the health care provider may pull the catheter gently until the inflated balloon is gently resting against the bladder neck. These steps complete the catheterization phase or phase "B" of the procedure.

Fig. 29 shows how the tray will look immediately after the catheter has been properly placed in the patient. Note that the drain tube 95 easily follows the catheter 92 toward the patient and away from the tray. A folded urine collection bag 96 is located in main chamber 1 in fig. 29 and may be packaged pre-connected to tubing 95, catheter 92, and/or other components of the catheter assembly. The urine collection bag 96 may be unfolded and suspended beneath the patient to collect urine as it drains from the patient.

After the patient has catheterized (i.e., after the catheter has been inserted and the retention balloon inflated in the patient's bladder), additional steps may be performed. For example, in phase "C" or the care and maintenance phase, the health care provider may: (1) securing Foley catheter to patient (e.g., using)

Devices), (2) positioning the urine bag and/or urine meter under the patient's bladder (e.g., hanging the urine bag on a hook on a bedrail at the foot of the bed) and securing the tubing to the bed sheet (e.g., with a clip) in such a way that the tubing does not kink, (3) recording the date of insertion by indicating the time and date of catheter insertion on a label and/or chart (e.g., label/sheet 72 shown in fig. 16) and recording the procedure according to hospital protocols, (4) maintaining the catheter (e.g., if it has a sterile red stamp, then maintaining the red stamp), (5) reevaluating indwelling catheter requirements, periodically evaluating whether the catheter becomes unnecessary, (6) and/or other care or maintenance steps.

Phase "C" and associated instructions/program instructions are identified in the main chamber of the catheterization tray, as shown in fig. 1, 2 and 5. For example, the phase "C" specification/program indication may include: "(1) using

Fastening Foley "," (2) placing a urine bag under the bladder "," fastening a tube to a bed sheet with a clip "," (3) recording the date of insertion "," (4) maintaining a red stamp according to hospital policy "," (5) periodically assessing catheter demand ". These descriptions/program instructions or other descriptions/program instructions may vary. A urine sample may be taken according to the instructions in fig. 14D. Finally, the catheter may be removed as indicated in fig. 14C.

The catheterization package(s) and catheterization tray(s) described herein may be manufactured/packaged in different ways. For example, the manufacturer or supplier of the urinary catheterization package may alter the steps or procedures described herein, may reorder the steps, may perform additional steps than those described, and/or may omit certain steps, as may be required by the situation and particular needs. Further, any of the features, components, arrangements, designs, ordering of components, etc. described above (e.g., features or arrangements that make use of the urinary catheterization package more intuitive or reasonable) may be added to or included in the urinary package during manufacturing, e.g., in the manufacturing/packaging process. However, non-limiting manufacturing/packaging methods are described below. The steps described herein may be performed in the order described or out of order.

In one embodiment, the urinary catheterization package is manufactured/packaged by providing a urinary catheterization tray (e.g., a urinary catheterization tray similar to or including those features shown in fig. 1-5 and described above). The tray may be purchased or formed by the manufacturer of the urinary catheterization package. If manufactured, the tray may be formed using an injection molding process or other suitable process. Instructions/program instructions may be integrated, printed, or otherwise included on the tray, as described above and shown, for example, in fig. 1, 2, and 5.

Various components (e.g., any of the components discussed above or elsewhere herein) may be added to the tray. In one embodiment, a pre-connection drainage system may be added to/included in a tray, for example, in main chamber 1 as shown in fig. 26. The drainage system may include: drainage/collection bag 96, drainage tube 95, catheter 92 (e.g., Foley catheter), drainage port, urine meter, or other drainage component. A swab or swab stick 34 may be added to/included in a tray, for example, the swab chamber 3 as shown in fig. 8 or 26. The specimen or sample container 54 and the label which may be filled with details about the specimen and adhered to the specimen or sample container may be added to/included in a tray, for example, in the corner storage compartment 5 as shown in fig. 26. A sterile skin cleanser bag or container 52 (e.g., a povidone iodine solution bag or container) may be added to/included in a tray, for example, on top of swab wand 34 in swab chamber 3 as shown in fig. 25. A package or container of lubricant 89 (e.g., a lubricous gel syringe) may be added to/included in a tray, e.g., a syringe chamber or catheter chamber 2 as shown in fig. 26. A sterile liquid syringe 88 (e.g., a 10cc sterile water syringe for inflating the retaining balloon of a Foley catheter) may be added to/included in a tray, e.g., in the syringe chamber or catheter chamber 2 as shown in fig. 26, on top of or part of the lubricating jelly syringe 89. A hole towel to be placed on the patient may be added to/included in the tray, for example on top of other components, and may span across portions of more than one chamber, as shown in fig. 24. A sheet to be placed under the patient's buttocks (e.g., a waterproof absorbent sheet) may be added to/included in the tray, e.g., on top of a hole towel or other component, and may span portions of more than one chamber. Both the drape and the hole towel are represented in the figures by the drape/hole towel 86. Gloves (e.g., rubber gloves, latex-free glove bag 58) may be added to/included in the tray, e.g., on top of the drape or other component, and may span portions of more than one chamber, as shown in fig. 22.

As shown in fig. 20-21, the tray and components may be sterilized and a sterile wrap 56 (e.g., CSR wrap) may be folded or wrapped around the catheterization tray. As shown in fig. 20, a belly band 46 may be included around the sterile wrap 56 (e.g., to maintain the sterile wrap in a folded configuration and to help maintain all contents inside the tray so the items do not move around). A perineal care (or perineal care) pack or kit 74 (e.g., as shown in fig. 17-19) may be added to/included in the urinary catheter, e.g., placed over the abdominal belt 46 and/or sterile wrap 56 as shown in fig. 17 and 18. The perineal care pack or kit 74 may include a hand sanitizer gel 76 (e.g., a sanitizer gel hand cleanser), a wet wipe 78 (e.g., a pack of olive soap wipes), instructions 80 (e.g., instructions for a health care provider and/or instructions for a patient), and/or other components (e.g., see fig. 19). An insert sheet or label 72 with instructions or other information may be added to/included in the catheterization package, for example, an insert sheet or label 72 with a list of safety considerations/steps and/or patient information charts may be included on top of the perineal care pack or kit, as shown in fig. 16. A detailed instruction file (e.g., as shown in fig. 14A-14D) and/or patient educational information (e.g., as shown in fig. 15A and 15B) may be added to/included in the catheterization package, e.g., a instructions for use (DFU) file 68 and/or patient educational book 70 may be included on top of the drop sheet, as shown in fig. 13. A packaging label 62 (e.g., as described above and illustrated in fig. 9-12) may be added to/included in the catheterization package, such as on top of all other components, with the edges folded down to cover the sides of the catheterization tray. The catheterization package may be sterilized and sealed, for example, in a sealed container or bag 60 as shown in fig. 9 and 10. Other components useful for catheterization or care may also be included.

In one embodiment, the catheterization system may include a ureteral catheter assembly and/or materials or supplies suitable or necessary for ureteral catheterization (e.g., catheterization elements or components, such as disinfecting liquids, lubricants, inflation liquids, gloves, etc.). For example, a catheterization system may include a catheterization tray having a plurality of chambers for receiving and/or securing a ureteral catheter assembly (e.g., an assembly including a Foley catheter) and other sterile and/or non-sterile catheterization elements, including any of the elements described above. The sterile catheterization element may be contained in the catheterization tray in such a way that the sterile element remains free from contamination by non-sterile catheterization elements.

The catheterization tray may include one or more visual program instructions or instructions that may assist the user during catheterization. For example, the program instructions may assist a user in orienting the catheterization tray (and component or element thereof) relative to the patient such that the catheterization component and/or element may be positioned in a predictable and suitable or desired position and/or orientation relative to the user and/or patient. Additionally or alternatively, the program instructions may assist the user in using the catheterization parts sequentially and/or removing the parts from the catheterization tray.

As mentioned above, catheterization trays and systems including such trays may facilitate sterile techniques during catheterization. In one embodiment, as shown in fig. 30A, the catheterization system 100 includes a container 110 (e.g., a sealed bag) that may be hermetically sealed or contain a catheterization tray and a catheterization member. For example, the container 110 may help maintain the sterility of the sterile catheterization component. For example, the container 110 may be a plastic bag (e.g., a polyethylene bag). Moreover, the container 110 may include a peelable side 111 that can be separated from a non-peelable side 112 to form an opening in the container 110 (the container 60 described above may have similar features and characteristics); the contents located in the container 110 may be removed through the opening.

In one embodiment, the catheterization tray and at least some of its contents (i.e., the catheterization component) may be at least partially surrounded or enclosed by the identification cover 120. In one embodiment, the package label or identification cover 120 (e.g., similar to the package label 62 discussed above) may include one or more visual identifiers including key information or variables, such as

visual identifiers

121, 122, 123 (e.g., these may be similar to the information squares discussed above), which may provide an indication related to the type and/or contents of the catheterization system 100.

For example, the package label or label cover 120 may be made from a sheet material, such as paper, cardboard, plastic (e.g., plastic film), and the like. The

visual identifiers

121, 122, 123 may be configured to convey sufficient information to the user to identify the particular type of the catheterization system 100 and/or its contents. For example, visual identifier 121 may identify a size of the catheter (e.g., a 16 french size, etc.). In one embodiment, the visual identifier 122 may indicate that the catheterization system 100 includes a urine meter (which may be attached to a catheter), and/or the visual identifier 123 may indicate that the catheterization system 100 includes a catheter stabilization device (e.g., STATLOCK).

The

visual identifiers

121, 122, 123 may be visually separated or isolated from each other. For example, the

visual identifiers

121, 122, 123 may include a generally square or rectangular perimeter outline that may define or define the exterior outline thereof. In other words, the identification information of the

visual identifier

121, 122, 123 may be contained within the generally rectangular outline of the

visual identifier

121, 122, 123. Thus, for example, a user may easily and/or quickly locate information relating to the identification cover 120 to identify and/or select a particular catheterization system 100 that is appropriate for the procedure.

One, some, or all of the

visual identifiers

121, 122, 123 may include any visual indication or information that may inform the user of the details of the catheterization system 100. For example, the

visual identifiers

121, 122, 123 may include text, images, symbols, and the like. Moreover, the

visual identifiers

121, 122, 123 and/or portions thereof may have any suitable color or colors that may assist a user in identifying and/or distinguishing the

visual identifiers

121, 122, 123. In one embodiment, at least one of the

visual identifiers

121, 122, 123 may have a different color than the others.

It should be appreciated that the particular outline shape, size, thickness, or combination thereof, surrounding or containing the identifying information of the

visual identifiers

121, 122, 123 may vary from implementation to implementation. Thus, the

visual identifiers

121, 122, 123 may have a generally circular, triangular, or polygonal shape. Further, the identification cover 120 may include any number of suitable materials that may carry the

visual identifiers

121, 122, 123 as a function of embodiment. For example, the

visual identifiers

121, 122, 123 may be printed, embossed, or otherwise transferred onto the identification cover 120.

The identification cover 120 can include any number of visual identifiers. In other words, the

visual identifiers

121, 122, 123 may be located on any number of suitable locations on the identification cover 120 and/or may be duplicated. For example, the identification cover 120 may include

visual identifiers

121, 122, 123 on its major faces and its minor faces. In one embodiment, the

visual identifiers

121, 122, 123 may be located on one, some, or all visible sides of the urinary catheterization system 100 (e.g., one, some, or all of the

visual identifiers

121, 122, 123 may be visible from either side of the urinary catheterization system during storage of the urinary catheterization system 100).

The identification cover 120 may be removed from the catheterization tray. For example, the identification cover 120 may be generally separable from the catheterization tray (e.g., the identification cover 120 may be located on the catheterization tray and may be secured relative to the catheterization tray by the receptacle 110). Further, as shown in fig. 30B, removal of the identification cover may expose a catheterization tray, which may be wrapped by or within a Central Supply Room (CSR) sterile wrap 130. Thus, the CSR sterile wrap 130 may at least temporarily secure the components in the catheterization tray.

The CSR sterile wrap 130 may be disassembled and removed from the catheterization tray and may be used during catheterization. For example, the CSR sterile wrap 130 may be placed near and/or under the patient to provide an at least partially sterile environment near the site of the catheterization, thereby reducing the risk of infection associated with the catheterization. The CSR sterile wrap 130 may be substantially opaque such that the contents of the catheterization tray, and/or the location of the catheterization components, are obscured or not visible to the user. Optionally, the CSR sterile wrap 130 may be translucent or transparent so that a user may view and/or visually identify the catheterization components contained in the catheterization tray.

The urinary catheterization system 100 may include a belly band or directional indicator wrap 140, which belly band or directional indicator wrap 140 may provide an indication of the relative positioning and/or orientation of the components in the urinary catheterization tray, which may not be visible to the user. For example, the binder or indicator wrap 140 may include a directional arrow 141 that a user may align to point at the catheterization site, which may orient the urinary tray and the urinary catheterization components therein relative to the patient. For example, orienting the catheterization tray with directional arrow 141 directed toward the insertion site may position the catheterization components and/or elements at least partially sequentially so that the catheterization components and/or components used earlier in the procedure are closer to the patient than the catheterization components intended to be used later in the procedure.

In addition, the binder or indicator wrap 140 may include a warning indicator 142 to alert the user to the proper sterility technique for catheterization. For example, alert indication 142 may include one or more particular elements that identify particular steps as appropriate or necessary to perform an appropriate sterile procedure. In one embodiment, warning indication 142 identifies one or more of the following steps: (1) opening the CSR sterile wrap 130; (2) wearing sterile gloves; (3) placing a cushion sheet; (4) placing a hole towel; or (5) following the procedure instructions located inside the catheterization tray.

Although the indicator wrap material 140 may be wrapped around the CSR sterile wrap 130, the present disclosure is not so limited. For example, a sticker or adhesive label may be attached to the CSR sterile wrap and may include the same or similar instructions as the instruction wrapper material 140. Alternatively or additionally, the indication may be placed directly on the CSR sterile wrap 130 (e.g., may be printed, embossed, or otherwise transferred thereto).

After removal or unpacking of the CSR sterile wrap 130 from the urinary tray, the contents of the urinary tray may be exposed. Fig. 31A shows the catheterization tray 200 of the catheterization system 100. The catheterization tray 200 may include a plurality of chambers that may secure or house various catheterization components. The shape and size of the urinary tray 200 may be defined by its sides. For example, the

sides

201, 202, 203, and 204 may define a generally rectangular outer shell or perimeter of the catheterization tray 200.

The urinary tray 200 may be molded (e.g., injection molded, thermoformed) or stamped (e.g., made of a plastic material). Accordingly, sides 201, 202, 203, and 204 may be formed from a sheet of material. One or more of

sides

201, 202, 203, or 204 may include stiffening ribs 205, which may provide stiffness and/or rigidity to

sides

201, 202, 203, 204. The stiffening ribs 205 may have a generally tapered shape and/or may protrude outward from the

respective side

201, 202, 203, or 204. More specifically, for example, the lower portion of the stiffening rib 205 (the portion closer to the bottom/floor of the urinary catheterization tray 200) may protrude more out of the

respective side

201, 202, 203, or 204 than the upper portion of the stiffening rib 205 (the portion closer to the opening of the urinary catheterization tray 200). At least a portion of one, some, or all of the strengthening ribs 205 may have a partial conical shape.

The urinary tray 200 may include a swab chamber 210, which may include one or more swabs 150 in the swab chamber 210. Additionally or alternatively, the chamber 210 may include a cleaning/sanitizing solution or sanitizer package 160 that may contain one or more sanitizers or cleaning/sanitizing solutions (e.g., containing a povidone-iodine solution). The chamber 210 may be positioned adjacent to and at least partially defined by the side 201 of the urinary tray 200. In some cases, the exterior of the sanitizer pack 160 can be non-sterile. Thus, the cleaning/disinfecting solution or disinfectant packet 160 may be placed in another package or bag, which may have a sterile exterior that may prevent or reduce contamination of other catheterization components in the catheterization tray 200 by non-sterile cleaning solution or disinfectant packet 160. The plastic bag may include a zipper or similar mechanism that a user may operate to open and access the bag 160 and/or other components therein.

The catheterization instructions may include images and descriptions of various steps or actions taken during catheterization. In some cases, the instructions may also identify specific step or action numbers, suggesting a specific sequence of steps or actions for catheterization. The catheterization instructions, which may be non-sterile, may be placed in a sterile container, such as a plastic bag, to isolate or separate the non-sterile instructions from the sterile catheterization components in the catheterization tray 200. Also, in some examples, the catheterization system may include multiple sets of catheterization instructions, which may improve compliance with sterile catheterization. For example, the catheterization instructions may be attached or adhered (e.g., as a sticker) to the inside of a sterile plastic bag and/or to another catheterization or component (e.g., a sterile container with a disinfectant pack 160), an external sleeve or portion of a catheterization system, and the like.

Chamber 210 may be configured to contain a sanitizing substance (e.g., a liquid) that may be dispensed into chamber 210 from sanitizer pack 160. For example, as described in more detail below, the chamber 210 may have a sloped bottom/floor such that cleaning or sanitizing solution (e.g., povidone-iodine solution) or sanitizer from the packet 160 may pool near and/or at a lowermost corner between the bottom/floor and a side (e.g., the divider 211) of the chamber 210. Further, the end of the swab 150 may be located at or near the lowermost corner between the bottom/floor and the sides of the chamber 210, such that the end of the swab 150 is located in the dispensed sanitizing liquid.

The chamber 210 may be at least partially defined by the side 201 or a portion of its inner wall, a divider 211, a divider 212, and an angled bottom/floor. For example, the lowest portion of the chamber 210 may be located at the corner edge formed between the divider 211 and the sloped bottom/floor. Thus, positioning the end/absorbent head of the swab 150 near the sloped bottom/floor and/or near the divider 211 of the chamber 210 may position the end/absorbent head of the swab 150 at or near the lowermost portion of the chamber 210.

As mentioned above, the urinary catheterization tray 200 may be oriented relative to the patient in such a way that the side 201 and the chamber 210 are closer to the insertion site than the side 203 of the urinary catheterization tray 200. In other words, orienting the catheterization tray 200 based on the directional arrows of the directional indicator wrap (while the contents and compartments of the catheterization tray 200 are hidden or covered by the CSR sterile wrap 130 (fig. 30B)) may place the sides 201 and compartments 210 near the insertion site. In some cases, the insertion site may be first sterilized with the swab 150, the swab 150 possibly being saturated with the sterilizing liquid from the sterilant packet 160. Thus, positioning the chamber 210 with the swab 150 and the antiseptic bag 160 near the insertion site may reduce spillage of the antiseptic liquid (e.g., on one or more of the urethral catheterization components in the urethral catheterization tray 200) and/or contamination of the swab 150, which may result in contamination of the insertion site.

As described in more detail below, the chamber 210 may have a sloped bottom/floor. For example, an upper edge (or surface) of the urinary catheterization tray 200, such as the upper edge 206, may lie in an imaginary plane, which may be substantially parallel to a support surface (e.g., a surface of a hospital bed) supporting the urinary catheterization tray 200. The sloped bottom/floor of the chamber 210 may have a non-parallel orientation with respect to an imaginary plane of the upper edge 206 and/or with respect to the support surface.

Further, the bottom/floor of the chamber 210 may be non-parallel with respect to the bottom/floor of one or more other chambers in the urinary catheterization tray 200. For example, the urinary catheterization tray 200 may be disposed on a support surface such that the bottom/floor of one or more chambers supports and/or orients the urinary catheterization tray 200 on the support surface. Thus, as described above, the bottom/floor of the chamber 210 may have a non-parallel orientation with respect to the support surface.

The catheterization tray 200 may include a side chamber 220. For example, the chamber 220 may extend along substantially the entire side or length of the urinary tray 200 (e.g., the chamber 220 may extend between the

sides

201 and 203 and/or may be partially defined thereby). Thus, in some cases, one side of chamber 220 may be defined by a side (such as side 204).

The chamber 220 may contain any number of suitable elements or components of a catheterization kit. For example, chamber 220 may comprise: a syringe 170 with a liquid that can be used to inflate the balloon of the catheter (as described below), and/or a syringe 180 that may contain a lubricant. Thus, the chamber 220 may be wide enough to accommodate the

syringes

170, 180. In some cases, the

syringes

170, 180 may be oriented longitudinally along the chamber 220 and may be arranged in a single row with one syringe in front of the other.

The catheterization tray 200 may include one or more cutouts or recesses in the divider 221, which may separate the chamber 220 from the adjacent chamber(s) (e.g., from the catheter chamber 230). For example, one or more recesses in the divider 221 may have a top edge that is below the upper edge 206 of the catheterization tray 200. More specifically, in some cases, the recess may provide access to one or more of the

syringes

170, 180 from the chamber 230. Thus, instead of or in addition to the access chamber 220, a user of the catheterization kit may remove the syringe 170 and/or the syringe 180 by accessing the chamber 230.

In one embodiment, the size of the

syringes

170 and 180 may be different. Thus, in one embodiment, at least a portion of the chamber 220 may be narrower than another portion thereof to accommodate different

sized syringes

170, 180. For example, the chamber 210 may include a narrowing protrusion (222), and the narrowing protrusion 222 may extend into the space of the chamber 220, thereby narrowing a portion of the chamber 220. For example, the syringe 170 may have a smaller diameter or peripheral dimension than the syringe 180. Thus, the narrowing protrusion 222 may narrow the width of the chamber 220, which chamber 220 may be wide enough to accommodate the syringe 180 (e.g., the narrowing protrusion 222 may prevent or limit lateral movement of the syringe 170 in the chamber 220).

As mentioned above, the urinary catheterization tray 200 may include a main chamber or catheter chamber 230. The chamber 230 may have a substantially rectangular shape. For example, chamber 230 and its shape may be at least partially defined by side 203, at least a portion of side 202, and

dividers

212, 221. While the chamber 230 may have a generally rectangular shape in one embodiment, it is understood that the shape of the chamber 230 may vary from embodiment to embodiment.

In any case, the chamber 230 is sized (e.g., perimeter size and depth), shaped, or otherwise configured to contain or house the catheter assembly 190. For example, catheter assembly 190 may include a catheter 191 that may be connected to a urine collection bag and/or urine meter 192. In some cases, the chamber 230 may also contain or house a STATLOCK 193 that can secure at least a portion of the catheter assembly 190 during catheterization.

The chamber 230 may have a substantially flat or planar bottom/floor, as described in more detail below. For example, the bottom/floor of the chamber 230 may support the urinary tray 200 on a support surface. Thus, in one embodiment, the bottom/floor of chamber 210 may have a non-parallel orientation with respect to the bottom/floor of chamber 230.

As mentioned above, the chamber 230 may have a generally rectangular shape. Further, the chamber 230 may have rounded or chamfered interior corners 231 between interior walls that define the perimeter of the chamber 230. Additionally or alternatively, the inner wall and/or the upper portion of the divider may have one or more chamfers or fillets 232 that may extend at least partially along their respective lengths.

The catheterization tray 200 may also include an auxiliary chamber 240 that may contain or house an auxiliary container 195 (e.g., a specimen or sample container). For example, the auxiliary container 195 may be generally cylindrical and may include a cap. Additionally, the chamber 240 may be shaped, sized, and configured to secure the auxiliary container 195 therein. In one embodiment, the length of chamber 240 may be similar to the length of auxiliary container 195 (e.g., chamber 240 may include a small gap or may be an interference fit with auxiliary container 195). In one embodiment, the bottom/floor of the chamber 240 may be semi-cylindrical or generally arcuate and may generally follow the generally cylindrical shape of the auxiliary container 195. Thus, for example, the bottom/floor of the chamber 240 may be at least partially wrapped around the auxiliary container 195.

For example, as shown in fig. 31B, chamber 240 may have a partially rounded bottom/floor 241. The chamber 240 may be separate from the chamber 210 in the catheterization tray 200. For example, the urinary tray 200 may include an overflow chamber 250 located between the

chambers

240, 210. In one embodiment, overflow chamber 250 may form a recess or depression between chamber 210 and chamber 240. For example, overflow chamber 250 may prevent or limit overflow of the sanitizing liquid dispensed into chamber 210. Also, the user may tap excess sanitizing liquid from the end of the swab 150 into the overflow chamber 250 prior to applying the sanitizing liquid at or near the insertion site.

The sloped bottom/floor 213 of the chamber 210 may be elevated or stepped above the overflow chamber 250. For example, the sloped bottom/floor 213 may terminate in a fillet or radius 214, and the fillet or radius 214 may extend from the sloped bottom/floor 213 downward toward the overflow chamber 250 or an edge thereof. Radius 214 may provide a transition between sloped bottom/floor 213 and at least a portion of overflow chamber 250 located below sloped bottom/floor 213. In any event, the sloped bottom/floor 213 may slope downward and away from the overflow chamber 250.

As mentioned above, the sanitizing liquid can be dispensed at the lowermost portion 215 of the chamber 210 (e.g., at or near the lowermost portion of the sloped bottom/floor 213). Further, the sanitizing liquid dispensed in the chamber 210 can generally flow toward and collect at the lowermost portion 215 of the chamber 210. Further, the end 151 of the swab 150 may be disposed or positioned in a disinfecting liquid. Thus, the user may remove the swab 150 from the chamber 210 and apply the sanitizing liquid at the insertion site without further action.

The swab 150 may be secured in the chamber 210 by positioning the tip(s) or absorbent head 151 in the sterile liquid dispensed in the chamber 210. For example, one, some, or each of the swabs 150 may include an elongated rod/stick 152 and an end/absorbent head 151 attached to the rod/stick 152. Also, the chamber 210 may include a channel 216 that may receive and secure the elongated stem/rod 152 of the swab 150. Thus, the stem/rod 152 of the swab 150 may be secured in the channel 216 of the chamber 210.

Channel 216 may include one or more retaining features (e.g., stops, protrusions) that may secure rod/stick 152 therein. For example, the stem 152 may have a generally rectangular shape or a generally rectangular cross-sectional shape. The retention feature may secure the elongated rod 152 in the channel 216 when the rod/stick 152 is oriented along the longer side of its rectangular cross-sectional shape. Also, rotating or twisting the swab 150 in the channel 216 (e.g., such that the shorter side of the rectangular cross-sectional shape of the stem 152 may be oriented to be located within the channel 216) may loosen the stem 152 from the channel 216.

In other words, the spacing between the retention features of the channel 216 may be less than the width of the long side of the rectangular cross-sectional shape of the elongated rods 152 such that the retention features may restrain the elongated rods/sticks 152 within the channel 216. Also, the spacing between the retention features may be greater than the length of the short side of the rectangular cross-sectional shape of the elongated rod/bar 152. Thus, twisting or rotating the swab 150 within the channel 216 may allow the elongated rod/wand 152 to pass between the retention features of the channel 216 in order to remove the elongated rod/wand 152 therefrom.

The urinary tray 200 (as well as the urinary trays shown in fig. 1-5) may be manufactured in any number of suitable ways and with any number of suitable manufacturing techniques. As mentioned above, the catheterization tray(s) may be injection molded, thermoformed or otherwise mass produced. For example, the urinary catheterization tray may be made from a plastic sheet that may be treated by compressing and heating the sheet into a suitable configuration, as described herein. Thus, one or more of the sides of the catheterization tray(s) may include a relatively thin plastic material (e.g., 0.005 inches, 0.010 inches, 0.020 inches, 0.050 inches, 0. catheterization system 100 inches, etc.). As mentioned above, the catheterization tray(s) may include stiffening ribs on one or more sides thereof, which may provide rigidity to such sides.

The catheterization tray(s) may include stiffening ribs as described herein on one or more dividers that divide the interior space of the catheterization tray(s) into chambers as described herein. Also, as described in more detail below, the divider (e.g., divider 221) may comprise a folded or double-ply sheet. The stiffening ribs may protrude away from the chambers (e.g., away from

chambers

210, 220, 230) and into the space between the layers of the sheet.

As described above, the interior corners and/or edges formed between the bottom/floor and the inner walls, sides, and/or dividers in the chamber may include rounded or chamfered corners. For example, such fillets or chamfers may reduce stress at interior corners or edges of the chamber. Accordingly, the fillets and/or chamfers formed at the interior corners and/or edges of the chamber may reduce or prevent breakage or failure of the sheet forming the urinary catheterization tray 200.

The bottom/floor of the chamber 230 may be substantially flat. Additionally or alternatively, the bottom/floor of the chamber 230 may have a protruding platform 232 and a recessed portion 233. For example, the recessed portion 233 may be lower or further from the upper edge 206 of the urinary tray 200 than the platform 232. Further, recessed portion 233 may wrap at least partially or completely around platform 232. Thus, for example, the recessed portion 233 can house at least a portion of a catheter, which can be wrapped around the platform 232.

As described above, the catheterization tray 200 may be placed on a support surface, such as the surface of a hospital bed. For example, as shown in fig. 31C, the recessed portion 233 of the chamber 230 may form a protrusion on the exterior of the urinary tray 200, while the platform 232 may form a recess on the exterior of the urinary tray 200. Thus, the outer surface of the recessed portion 233 may provide or form a surface that may orient and/or support the urinary catheter tray 200 on a support surface. Also, in one embodiment, the exterior surface of the recessed portion 233 may be substantially parallel to an imaginary plane of the upper edge 206.

Also, as mentioned above, the channels 216 of the chamber 210 may be generally parallel to the sloped bottom/floor 213 and may be sloped or non-parallel with respect to the support surface. The channels 216 of the chamber 210 may have a non-parallel orientation with respect to the exterior surface of the recessed portion 233. For example, on the exterior of the urinary catheter tray 200, the channel 216 may protrude outwardly away from the sloped bottom/floor 213.

The chamber (e.g., chamber 210) of the catheterization tray, or a portion thereof, may carry a disinfecting or cleaning liquid (e.g., povidone-iodine solution) therein. For example, at least a portion of the chamber may carry a sanitizing liquid and may be sealed by a peelable lid. Thus, during catheterization, the user may avoid pouring the sterile liquid from the bag (e.g., into a catheterization tray), which may prevent or reduce spillage of the sterile liquid. The swabs may be at least partially submerged in the disinfecting liquid and/or sealed together at least partially by a peelable cover. Alternatively or additionally, the swab may be located in another chamber of the catheterization tray.

As described above, the divider of the urinary catheterization tray 200 may be formed of two layers of sheet material. At least some of the separators may have spaces between the layers of sheet material. For example, the divider 221 can include a first layer 221a and a second layer 221b that are spaced apart from each other (e.g., the first layer 221a can define or form a perimeter of the chamber 230 and the second layer 221b can define or form a perimeter of the chamber 220.

The reinforcing ribs 205 on the first layer 221a of the separator 221 may protrude outward, away from the chamber 230 and into the space between the first layer 221a and the second layer 221 b. The stiffening ribs 205 on the second layer 221b may also protrude outward, away from the chamber 220 and toward the outer perimeter or circumference of the catheterization tray 200. In any case, as described above, the chamber of the urinary catheter tray 200 may have recesses corresponding to protrusions formed by the reinforcing ribs 205 on the outside of the urinary catheter tray 200.

The catheterization tray 200 may include one or more instructions or program instructions that may assist the user during catheterization. For example, as shown in fig. 32, the catheterization tray 200 may include

instructions

301 and 307, which may be printed on the catheterization tray 200. For example, during catheterization, the first indication 301 may instruct the user to open a bag containing a disinfecting liquid, and the second indication 302 may instruct the user to pour the disinfecting liquid in the chamber 210.

The third indication 303 may indicate to the user to attach a syringe containing a liquid for inflating the catheter balloon to the catheter. In one embodiment, the fourth indication 304 may indicate to the user that lubricant is to be dispensed, and/or may identify or suggest a location in the chamber 220 for dispensing lubricant. Moreover, the indications 305-307 may identify additional or alternative steps to be performed during catheterization (e.g., retrieving the genitals (using a non-dominant hand), preparing the patient with a swab (using a dominant hand), inserting a catheter, and inflating a balloon (using a dominant hand)).

The urinary tray 200 may include enlarged or bolded printing of the instructions 301-307 to improve visibility. Further, other enlarged instructions/instructions may be printed on the bottom/floor of the chamber 230, as shown in fig. 32. The presence of the indications 301-307 on the catheterization tray 200 may avoid or reduce the necessity of printing brochures or similar instructions.

In one embodiment, as shown in fig. 33, the catheterization system 100a may include one or more procedure instructions 260a on the CSR sterile wrap 130 a. Unless otherwise described herein, the catheterization system 100A and its elements and components may be similar or identical to the catheterization system 100 (fig. 30A-32) and its respective elements and components. For example, the catheterization system 100a may include a catheterization tray 200 and the catheterization elements and/or components described above in connection with the catheterization tray 200.

In one embodiment, CSR sterile wrap 130a may include one or more procedure instructions 260a that may assist the user during catheterization. For example, one or more of the program indications 260a may be individually isolated and/or delimited, or otherwise visually enclosed by a perimeter outline. In particular, isolating each program directive 260a may draw or focus the user's attention to the program directive and may facilitate its identification. The program indication 260a may contain similar or identical information as the indications 301-307 (fig. 32).

In one embodiment, the catheterization tray may include a hole towel that may partially cover the patient and may facilitate insertion of the catheter. Fig. 34 shows a hole towel 270. The hole towel 270 may have a generally rectangular shape. Further, the hole towel 270 may include perforations 271. In particular, the perforations 271 may generally form the shape of cuts in the hole towel 270 that may be formed by tearing a portion of the hole towel 270 defined by the perforations 271. In one embodiment, the central portion of the hole towel 270 has been opened, i.e., the central material inside the area bounded by the perforations 271 is removed prior to packaging the hole towel 270.

The shape defined by the perforations 271 or the shape of the central opening may be adapted to access the patient's genitals in order to perform catheterization after covering the patient with a hole towel 270. Also, in some cases, the hole towel 270 may include side cuts 272. For example, the side notches 272 may be generally V-shaped. In one embodiment, the side cuts 272 may facilitate placement of the hole towel 270 around the patient's leg.

As mentioned above, the catheterization system may include various components that may facilitate catheterization, such as a swab that may facilitate sterilization of the area near or at the catheterization site. Fig. 35 shows a swab 150. For example, the swab 150 may include an elongated member or rod/stick 152 and an end/absorbent head 151 attached to the rod/stick.

The tip/absorbent head 151 may have a generally rounded outward or distal portion and a tapered proximal portion (e.g., tapering toward the proximal end of the tip/absorbent head 151 and toward the elongated rod/wand 152). For example, the tip/absorbent head 151 may be narrower at the proximal end than the distal portion (i.e., the distal portion may be generally flared and its leading edge may be generally rounded).

The tip/absorbent head 151 may comprise any suitable material, which may vary from embodiment to embodiment. The tip/absorbent 151 may include or contain a liquid absorbent material that can absorb the disinfecting liquid and then dispense the disinfecting liquid onto and/or near the catheterization site. For example, the tip/absorbent head 151 may comprise a suitable foam, sponge, cotton, or the like.

The tip/absorbent head 151 may be attached to the elongated rod/wand 152 using any number of suitable mechanisms, which may vary from embodiment to embodiment. For example, the tip/absorbent head 151 may be attached to the elongated rod/wand 152 with an adhesive, may be ultrasonically welded to the rod/wand 152, and so forth. The elongated rod 152 may enter the tip/absorption head 151 to a predetermined depth, which may help to properly secure the tip/absorption head 151 and the elongated rod/wand 152 together while leaving a sufficient portion of the tip/absorption head 151 outside of the elongated rod/wand 152 (e.g., in a manner that avoids the elongated rod/wand 152 contacting and/or injuring the patient during application of the antiseptic liquid at the insertion site). For example, the tip/absorbent head 151 may have sufficient flexibility and sufficient elasticity and/or rigidity after being secured to the elongated rod/wand 152 such that the tip may remain substantially unflexed after absorbing the disinfecting liquid and may elastically bend during application of the disinfecting liquid to the insertion site.

As described above, in some embodiments, the catheter assemblies in the catheterization tray may be oriented generally parallel to the support surface supporting the catheterization tray. The catheter assemblies in the catheterization tray may be oriented generally vertically or perpendicular to the support surface. Fig. 36A-36B illustrate a catheterization system 100a including a catheterization tray 200a that secures a catheter assembly and/or one or more components or elements for catheterization. Unless described herein, the catheterization system 100A and its elements and components may be similar or identical to the catheterization system 100 (fig. 30A) and its elements or components. For example, unless described herein, the catheterization tray 200a and the catheterization elements and components contained in the catheterization tray 200a may be similar to the catheterization tray 200 (fig. 31A-32) and the catheterization elements or components contained therein.

For example, as shown in FIG. 36A, the catheterization tray 200a may have a generally rectangular shape, which may be defined by sides 201a-204 a. The sides 201a-204a may be generally planar and, thus, may define a box-like structure or perimeter of the catheterization tray 200 a. The catheterization tray 200a may also include a top chamber 210a, which may contain instructions and/or one or more catheterization components. In one embodiment, the top chamber 210a may be defined by dividers 211a, 212a and a bottom 213 a. In one embodiment, the dividers 211a, 212a and/or the bottom 213a are removable from the catheterization tray 200 a.

In one embodiment, removal of the dividers 211a, 212a and/or the bottom 213a may provide access to additional catheterization components contained in the catheterization tray 200 a. For example, as shown in fig. 36B, after removing the dividers 211a, 212a and the bottom 213a (fig. 36A), the central chamber 220a of the catheterization tray 200a may be exposed and/or accessible to the user. For example, chamber 220a may house or contain a catheter assembly 190. In one embodiment, chamber 210a may be separated from an adjacent chamber by one or more dividers (e.g., by dividers 221a, 222 a). As mentioned above, the catheter assembly 190 in the chamber 210a may be oriented substantially perpendicular relative to a support surface (e.g., when the urinary tray 200a is placed on a support surface, such as a surface of a hospital bed).

In one embodiment, the divider 221a, 222a may separate the central chamber 220a from the

adjacent chambers

230a, 240 a. The chambers 230a and/or 240a may house or contain various catheterization elements or components for a procedure, which may be similar or identical to the catheterization components described above in connection with the catheterization tray 200 (fig. 31A-32). In some cases, the dividers 221 and/or 222a may be removable from the catheterization tray 200a, which may facilitate removal of the catheterization elements or components from the catheterization tray 200 a.

The catheterization tray 200a may be constructed of any suitable material. For example, the urinary tray 200a may be constructed from a thick sheet of material or panel (e.g., plastic material). For example, the panel thickness may be one or more of the following ranges: about 0.1 inches to about 0.2 inches; about 0.15 inches to about 0.3 inches; about 0.25 inches to about 0.5 inches. However, it should be appreciated that the panel thickness may be less than 0.1 inches or greater than 0.5 inches. Also, the catheterization tray 200a may be reused after a catheterization procedure (e.g., the catheterization tray 200a may be sterilized and/or repackaged for reuse).

In one embodiment, the catheterization tray may be at least partially disassembled (e.g., in addition to or in lieu of removing the divider). FIG. 37A illustrates a catheterization system 100b that may include a catheterization tray 200b that may be deployed to access the contents therein. As mentioned above, the catheterization system 100b may include a catheterization tray 200b that may be wrapped in a CSR sterile wrap 130b that may be unpacked to access the catheterization tray 200 b. For example, initially, flap or portion 131b of CSR sterile wrap 130b may be deployed toward the patient (e.g., so as to cover the support surface with sterile portion 131b of CSR sterile wrap 130 b).

In one embodiment, the CSR sterile wrap 130b may include a pocket 132b that may be exposed when the CSR sterile wrap 130b is detached to expose the catheterization tray 200 b. In one embodiment, used items or trash may be placed in the pocket 132b during and/or after catheterization. The waste may then be disposed with the CSR sterile wrap 130 b.

A hole towel (e.g., hole towel 270) may be attached to the CSR sterile wrap 130b such that after unpacking the CSR sterile wrap 130b, the hole towel is exposed and may be removed from the CSR sterile wrap 130b and used for catheterization. In one embodiment, the hole towel 270 may be attached to the CSR sterile wrap 130b in any suitable manner, which may vary from embodiment to embodiment. In one embodiment, the hole towel 270 may be attached to the CSR sterile wrap 130b with a light colored adhesive, tape, label, or the like.

As mentioned above, the catheterization tray 200b may be exposed after unpacking the CSR sterile wrap 130 b. The catheterization tray 200b may include one or more identifiers 260b that may identify or suggest steps and/or sequences of use of the catheterization components in a catheterization procedure (e.g., the identifiers may be on one or more outer surfaces of the catheterization tray 200 b). For example, the identifier 260b may be located on the top surface of the catheterization tray 200b and may indicate a further step in the catheterization. According to one embodiment, the top panel 201b of the catheterization tray 200b may be opened to deploy the catheterization tray 200b and access the catheterization components in the catheterization tray 200 b.

As shown in fig. 37B, after opening the catheterization tray 200B, the user may access the chamber 210B, which may contain the catheter assembly 190 for catheterization. For example, the top panel 201b, together with the side panels 202b (connected thereto), may be unfolded away from the

panels

203b, 204b, 205 b. More specifically,

side panels

203b, 204b, and reinforcing ribs 205b may partially define the perimeter of chamber 210 b. Unfolding the side panel 202b and the top panel 201b from the

side panels

203b, 204b, 205b can provide access to the chamber 210b through the sides (from which the side panel 202b is unfolded) and through the top (from which the top panel 201b is removed). In one embodiment, the side panel 202b and top panel 201b may be deployed in a general direction opposite or away from the insertion site (e.g., in a manner that does not interfere with catheterization).

Also, on the inner surface of the faceplate 201b, the catheterization tray 200b may include additional or alternative catheterization components, such as a syringe 170 and a swab 150. Such a urethral catheterization component may be attached or secured to the top panel 201b and/or the side panel 202 b. For example, the injector 170 may be secured to the top panel 201b with one or more straps 220 b. Further, in some cases, the pledget 150 may be secured to the top panel 201b within one or more pockets 230 b. It should be appreciated that the urethral catheterization component (such as the syringe 170, swab 150, etc.) may be attached or secured to the top panel 201b (e.g., adhesive, label, etc.) in any number of suitable manners and with any number of suitable mechanisms. In any event, the urethral catheterization component secured within the top panel 201b and/or the side panel 202b may be accessible and removable therefrom after it is deployed away from the

side panels

203b, 204b, 205 b.

Further, the side panel 202b and/or the top panel 201b may include one or more program instructions 260b near one or more corresponding urethral catheterization components. For example, the program instructions 260b may identify the catheterization component with a number corresponding to a suggested step number in a suggested sequence of steps for catheterization. Further, the urethral catheterization components and corresponding procedure instructions 260b may be arranged in a sequential manner such that the instructions with higher numbers and corresponding urethral catheterization components are generally positioned farther and farther from the insertion site. In other words, the urethral catheterization member used earlier in catheterization may be located closer to the insertion site, while the urethral catheterization member used later in catheterization is located further away from the insertion site (based on the orientation of the urethral catheterization tray 200 b).

In one embodiment, the catheterization tray 200b may include a horizontal panel 207b that may be connected to and extend from the side panel 204b (e.g., the horizontal panel 207b may be folded into the chamber 210b and/or may be substantially parallel to a support surface supporting the catheterization tray 200 b). In some cases, horizontal panel 207b may support and/or secure one or more urinary catheterization components. For example, the horizontal panel 207b may secure the pouch 180b with lubricant that may be removed from the pouch and used in catheterization.

In one embodiment, the side panels 204b and the horizontal panel 207b can be unfolded away from the

side panels

203b and 205b, as shown in fig. 37C. For example, unfolding side panel 204b may provide access into compartment 210 b. Further, one or more urinary catheterization components may be attached to the inside (on the inner surface) of the side panel 204b and/or the horizontal panel 207 b. For example, the sanitizer pack 160 can be attached to the horizontal panel 207b and/or the side panel 204b (e.g., with a light colored adhesive). In addition, the catheterization tray 200b may include instructions 260b that identify the steps or specific order or location in the catheterization sequence in which the disinfectant pack 160 may be used.

As described above, the catheterization system may include a catheterization tray that is wrapped into a sterile wrap that may be used during catheterization. The catheterization system may include one or more catheterization components packaged and/or secured therein with a sterile wrap (e.g., directly in the sterile wrap, without a catheterization tray). Such a catheterization system may reduce waste or material discarded after catheterization. For example, after the catheterization material is completed, the sterile wrap may be disposed of and/or composted to reduce long-term waste from the catheterization system.

In light of the foregoing, fig. 38A, 39A, 40A, 41A, 42A, and 43A provide a medical procedure tray for a medical procedure package (e.g., a catheterization tray for a catheterization package) in accordance with some alternative embodiments of the foregoing medical procedure tray. For ease of illustration, features of the alternative embodiment that are shared with the medical procedure tray described in detail above will not be described in detail below. It should be understood that when alternative embodiments are described, the description of each shared feature is incorporated by reference into the name of the shared feature as appropriate. For additional illustrative convenience, each feature of the alternative embodiments shared with the previously described medical procedure tray will not be further described. Rather, it should be understood that the shared visual elements between the alternative embodiment and the previously described medical procedure tray represent shared features between the alternative embodiment and the previously described medical procedure tray. Thus, the shared visual elements provide a basis for the description of each shared feature incorporated by reference into alternative embodiments as appropriate. For example, fig. 2 and 38A provide a medical procedure tray that includes stiffening ribs. (see stiffener 20 of fig. 2 and description thereof.) although the stiffener of the alternative embodiment of fig. 38A is not explicitly described, the description of the stiffener is incorporated by reference in view of the shared visual elements that represent the stiffener.

Fig. 38A shows a view of another medical procedure tray 3800 according to some embodiments. Fig. 38B shows another view of the medical procedure tray 3800 of fig. 38A. Fig. 38C shows another view of the medical procedure tray 3800 of fig. 38A along with a lid 3801. Fig. 38D shows another view of the medical procedure tray 3801 of fig. 38A along with a lid 3801.

The medical procedure tray 3800 of fig. 38A, 38B, 38C, and 38D may include a first portion 3810, a second portion 3820, and a third portion 3830. As described herein, a portion of a medical procedure tray may be designated for one or more particular uses (e.g., a well for iodine, a portion for storage, etc.), and a portion may be at least partially and up to completely separated from one or more other portions by one or more physical features (e.g., one or more dividers), thereby forming a chamber for one or more particular uses. As shown, medical procedure tray 3800 includes a first divider 3842 formed from medical procedure tray 3800 itself. First divider 3842 or at least a first portion-facing face of first divider 3842 (see fig. 38A) has a first height h equal to the height of medical procedure tray 3800 at least one end of medical procedure tray 3800 including second portion 3820 (see fig. 38A)_i. The first divider 3842, or at least a face of the first divider 3842 facing the first portion (see fig. 38A), has a second height h, less than the first height, at least at an end of the medical procedure tray 3800 opposite the second portion 3820₂. In view of first divider 3842, first portion 3810 may be considered a first chamber 3810 that is at least partially separated from third portion 3830 and completely separated from second portion 3820. As further illustrated, the medical procedure tray 3800 includes a second divider 3844 formed by the medical procedure tray 3800 itself. The second divider 3844, or at least the third portion-facing face of the second divider 3844 (see fig. 38A or 38B), has a first height equal to the height of the medical procedure tray 3800. In view of the first and

second dividers

3842, 3844, the second portion 3820 may be considered a second chamber 3820 that is completely separated from the first and

third portions

3810, 3830. With further regard to the first and

second separators

3842, 3844, the third portion 3830 may be considered a third chamber 3830 that is at least partially separated from the first portion 3810 and completely separated from the second portion 3820.

As with the medical procedure trays previously described, medical procedure tray 3800 may include medical procedure instructions imprinted directly on medical procedure tray 3800, where at least some of the instructions may be revealed in synchronization with the steps of the medical procedure. When the medical procedure tray 3800 is incorporated into a medical procedure package having contents for a medical procedure (e.g., a drainage system for catheterization including a catheter, a lubricant container, a water syringe, a skin preparation kit, etc.), the step-by-step removal of the contents may reveal a step-by-step description of the medical procedure imprinted on the medical procedure tray 3800.

With respect to the first portion or chamber 3810, the first portion 3810 may be configured to accommodate a first set of contents for a medical procedure. In some embodiments, the medical procedure is catheterization, and the first set of contents may include, but is not limited to, a drainage system including a catheter (e.g., a Foley catheter), a drainage tube, and a drainage bag. The first set of contents may also include a sterile water syringe for inflating a balloon (such as a balloon of a Foley catheter). When the medical procedure tray 3800 is incorporated into a medical procedure package, the first portion 3810 may include a first set of contents. For visual reference, the medical procedure tray 3800 of fig. 38A, 38B, 38C, and 38D is shown with a sterile water syringe 3892. As shown in fig. 38A and 38B, sterile water syringe 3892 may simply be placed next to the interior wall of medical procedure tray 3800 or fitted into place next to the interior wall by a loose-fit interference fit at both ends of sterile water syringe 3892. As shown in fig. 38C and 38D, sterile water syringe 3892 may still be placed next to the inner wall of medical procedure tray 3800; however, sterile water syringe 3892 may be further placed within the folded portion or retainer 3803 of cap 3801.

Referring to fig. 38C and 38D, the medical procedure tray 3800 is displayed with a cover 3801, such as the package label 62 described with reference to fig. 11 and 12, the identification cover 120 described with reference to fig. 30A, or a combination thereof. As further illustrated, the cover 3801 may be folded to form a retainer 3803 for retaining certain contents of the medical kit in the first portion 3810. For example, retainer 3803 may be configured to hold sterile water syringe 3892 in first portion 3810 separate from certain other contents of the medical kit in first portion 3810. Other portions of the cap 3801 may be folded to form other retainers for retaining the contents of the medical procedure package in the appropriate portion. As shown, the cover 3801 may be configured to fit within the first portion 3810 of the medical procedure tray 3800; however, the cover 3801 may alternatively be configured to fit within the first portion 3810 and additional portions (e.g., the second portion 3820, the third portion 3830, etc.) of the medical procedure tray 3800, or portions thereof. The cover 3801 may alternatively be configured to fit over the medical procedure tray 4100 in any of the aforementioned configurations, up to the entire medical procedure tray 4100 except for the folded or otherwise shaped portion of the cover 3801 that forms a retainer for retaining the contents of the medical procedure package in the appropriate portion.

With respect to the second portion or chamber 3820, the second portion 3820 may be configured to receive a second set of contents for a medical procedure. In some embodiments, the medical procedure is catheterization, and the second set of contents may include, but is not limited to, a container containing a lubricant (e.g., a lubricant for Foley catheters). When the medical procedure tray 3800 is incorporated into a medical procedure package, the second portion 3820 can include a second set of contents. For visual reference, the medical procedure tray 3800 of fig. 38A and 38B is shown with a lubricant container 3894.

With respect to the configuration of the second portion or chamber 3820 for the second set of contents, the second portion 3820 may be configured as a retainer to retain or otherwise secure the second set of contents (e.g., lubricant container 3894) while providing an open access to facilitate easy removal of the second set of contents. The second divider 3844 formed by the medical procedure tray 3800 can have the previously described first height (e.g., equal to the height of the medical procedure tray 3800) at a face of the second divider 3844 facing the third portion (see fig. 38A or 38B); however, the second divider 3844 may also have a second height at a face of the second divider 3844 facing the second portion. The second height at the face of the second divider 3844 facing the second portion may be less than the first height at the face of the second divider 3844 facing the third portion, which in turn serves to lift the bottom 3822 of the second portion 3820 above the first portion 3810 or the bottom 3812 of the tray 3800 (see fig. 38B). Again, for visual reference, the medical procedure tray 3800 of fig. 38A and 38B is shown with a lubricant container 3894. The lubricant container 3894 may fit to a location beside the inner wall of the medical procedure tray 3800 (or a protrusion thereof) shared with the second portion 3820 and a face of the second divider 3844 facing the second portion, with a loose-fit interference fit at both sides of the lubricant container 3894, at both ends of the lubricant container 3894, or a combination thereof. The bottom 3822 of the second portion 3820 is raised above the bottom 3812 of the first portion 3810, or the tray 3800 provides an open access that facilitates easy removal of the second set of contents.

With respect to the third portion or chamber 3830, the third portion 3830 can be configured to receive a third set of contents for a medical procedure. In some embodiments, the medical procedure is catheterization, and the third set of contents may include, but is not limited to, a sample container, optionally a label for the sample container, and a skin preparation kit including a disinfectant package (e.g., an iodophor, such as povidone-iodine, iodine tincture, aqueous iodine, etc.) and one or more swabs. When the medical procedure tray 3800 is incorporated into a medical procedure package, the third portion 3830 can include a third set of contents. The medical procedure tray 3800 of fig. 38A and 38B is shown without a sample container or skin preparation kit; however, fig. 8, 26, and 27 provide a visual reference to the inclusion of the one or more swabs 34 in the medical procedure tray 3800, fig. 25-29 provide a visual reference to the inclusion of the sample container 54 in the medical procedure tray 3800, and fig. 25 provides a visual reference to the inclusion of the antiseptic bag 52 in the medical procedure tray 3800.

With respect to the configuration of the third portion or chamber 3830 for the third set of contents, the third portion 3830 may be configured with one or more additional sub-portions or sub-chambers. As shown in fig. 38A and 38B, the one or more additional subsections or subchambers can include a swab chamber 3832, an overflow chamber 3834, and a corner storage chamber 3836. Swab chamber 3832, in turn, may include a well 3831 and one or more channels, one of which is indicated as channel 3833. The well 3831 may be positioned at the base of a second divider 3844, which separates the second portion 3820 from the third portion 3830, as shown in fig. 38A and 38B. The well 3831 may be further positioned at a base of the one or more channels so as to abut each of the one or more channels at a well end thereof. The well 3831 may be configured to hold a fluid, such as a sanitizer for a medical procedure kit, when the fluid is poured therein.

The one or more channels may be configured to separately hold the one or more swabs of the skin preparation kit for subsequent use with a disinfectant in a disinfectant pack. Each of the one or more channels may be configured to optionally retain a respective one of the one or more swabs under at least one snap feature or snap tab located along a length or longitudinal side of the channel. Any two or more snap tabs (such as any three or more snap tabs) and, for example, any four or more snap tabs located along the length or longitudinal sides of the channel may be staggered relative to one another. As shown in fig. 38A and 38B, each of the one or more channels may include three staggered snap tabs along a longitudinal side thereof. (see also fig. 8 and description thereof.) each of the one or more channels may also be configured to be inclined or angled relative to the bottom 3812 of the tray 3800. Further, each of the one or more channels may be configured in a triangular or triangular shape at its well end adjacent to well 3831. With this configuration, the handle end of the swab held below the snap tab of the channel can be raised relative to the absorbent head end of the swab when the absorbent head end is positioned in its receiving triangle (acomodating delta). Thus, the absorbent head of the swab may be angled downward into the well 3831 of the swab chamber 3832 of the third portion 3830, and the elongated member of the swab may be angled upward for grasping and removal in the appropriate step of unpacking the medical kit containing the tray 3800 and swab.

An overflow chamber 3834 may be positioned at an end of the one or more channels opposite the well 3831. The overflow chamber 3834 may be fluidly connected to the well 3831 via the one or more channels, each of which may also be configured to convey fluid (e.g., a sanitizer of a skin preparation kit) along its length as the fluid is poured therein or thereon. If the medical procedure requires additional antiseptic agent for skin preparation or the like, the additional antiseptic agent may be safely added to the well 3831, ensuring that any volume of antiseptic agent that exceeds the total capacity of the swab chamber 3832 (e.g., the combined capacity of the well 3831 and the one or more channels) may overflow into the overflow chamber 3834 via the one or more channels.

With respect to the corner storage chamber 3836, the corner storage may be positioned between the overflow chamber 3834 and the inner wall of the tray 3800, and thereby share the inner wall of the tray 3800. The corner storage chambers 3836 may be configured to receive sample containers of medical procedure packages. Further, while the medical procedure package may include a sterilant package in or over the swab chamber 3832 and the overflow chamber 3834 as shown in fig. 25, the corner storage chambers 3836 may also be configured to receive at least a portion of the sterilant package. In this configuration, the disinfectant packet may be placed in or over swab chamber 3832, overflow chamber 3834, corner storage chamber 3836, or a combination thereof in the medical procedure packet containing tray 3800.

Fig. 39A shows a view of another medical procedure tray 3900 according to some embodiments. Fig. 39B shows another view of the medical procedure tray 3900 of fig. 39A.

The medical procedure tray 3900A of fig. 39A and 39B may have a configuration similar to the medical procedure tray 3800 described with reference to fig. 38A, 38B, 38C, and 38D. Thus, the tray 3900A may likewise include a first portion or first chamber 3910, a second portion or second chamber 3920, and a third portion or third chamber 3930, each of which may be configured to contain and hold contents for a medical procedure. However, as shown, the first portion 3910 of the tray 3900A may have a different configuration than the first portion 3810 of the tray 3800. For example, the first portion 3810 of the tray 3800 of fig. 38A, 38B, 38C, and 38D has a more square footprint, while the first portion 3910 of the tray 3900A of fig. 39A and 39B has a more rectangular footprint. This is due to the fact that the side of tray 3900A that surrounds first portion 3910 (e.g., the side of tray 3900A that is adjacent to sterile water syringe 3892 and the opposing side thereof) is longer than the similar side of tray 3800 that surrounds first portion 3810. Configuring first portion 3910 in this manner allows for a relatively greater capacity for relatively more of the contents of a medical package including tray 3900A.

Not only may the first portion 3910 of the tray 3900A have a different configuration than the first portion 3810 of the tray 3800, but also the one or more dividers of the tray 3900A may have a different configuration than the one or more dividers of the tray 3800. Although not shown in fig. 39A and 39B, a different configuration may include a disproportionately or proportionally shorter height for the one or more dividers of tray 3900A, which may have a height equal to the tray height (e.g., a maximum height), than the one or more dividers of tray 3800. For embodiments of disproportionately shorter heights, the first divider 3942 of the tray 3900A may have a disproportionately shorter height than the first divider 3842 of the tray 3800, wherein a similar first height h of the first divider 3942_iMay be greater than the first height h of the first divider 3842_iShort, and wherein a similar second height h of first divider 3942₂May be substantially the same as the second height h of the first divider 3842₂The same is true. Fig. 41B provides a visual reference for this disproportionately shorter height of first divider 3942 as compared to first divider 3842, it being understood that first divider 3942 of tray 3900A continues to the inner wall of tray 3900A as shown in fig. 39A and 39B. For proportionally shorter height embodiments, the second divider 3944 of tray 3900A may have a proportionally shorter height than the second divider 3844 of tray 3800. Fig. 41B also provides a visual reference of this proportionately shorter height of the second divider 3944 as compared to the second divider 3844. Configuring the one or more dividers of tray 3900A to be disproportionately or proportionately shorter in height than the one or more dividers of tray 3800 allows the bottom of second portion 3920 to be lower than bottom 3822 of second portion 3820 of tray 3800 while still providing an open path that facilitates easy removal of lubricant container 3894. For example, the bottom of the second portion 3920 may be substantially coplanar with the bottom of the first portion 3910 or the bottom of the tray 3900A. FIG. 41B is a schematic view of aAgain providing a visual reference to such a bottom of the second portion 3920 of the tray 3900A, it should be appreciated that the first divider 3942 of the tray 3900A continues to the inner wall of the tray 3900A, as shown in fig. 39A and 39B. The co-planar bottom of second portion 3920 of tray 3900A and the elevated bottom 3822 of tray 3800 provide an open path that facilitates easy removal of lubricant container 3894 because neither embodiment allows lubricant container 3894 to settle too deeply into the second portion well.

Although embodiments of an elevated second portion bottom of the tray (e.g., elevated bottom 3822 of second portion 3820 of tray 3800) and a second portion bottom coplanar with the tray bottom (e.g., coplanar bottom of second portion 3920 of tray 3900A) are disclosed, it should be understood that the elevation of the bottom of any of the chambers of any of the medical procedure trays disclosed herein relative to the tray bottom may vary from the description of

trays

3800 and 3900A.

Fig. 39C shows a view of a medical procedure tray 3900B including a plurality of holders in a first configuration, according to some embodiments.

The medical procedure tray 3900B of fig. 39C may have a configuration similar to the medical procedure tray 3900A described with reference to fig. 39A and 39B. Thus, tray 3900B may likewise include a first portion 3910, a second portion 3920, and a third portion 3930, each of which may be configured to contain and hold contents for a medical procedure. However, as shown, first portion 3910 of tray 3900B may have a different configuration than first portion 3910 of tray 3900A. For example, first portion 3910 of tray 3900B of fig. 39C may have multiple holders, one of which is indicated as holder 3912. In contrast, the first portion 3910 of the tray 3900A of fig. 39A and 39B is shown without the plurality of holders; however, it should be understood that tray 3900A, as well as any tray provided herein, may optionally include any type of holder or holders provided herein. The plurality of holders in the first portion 3910 of the tray 3900B may be configured to hold certain contents of medical packages in the first portion 3910. For example, the plurality of retainers may be configured to keep sterile water syringes 3892 in the first portion 3910 separate from certain other contents of the medical kit in the first portion 3910. Any of a variety of different types of retainers can be formed (e.g., cylindrical or tapered cylindrical retainers, bracket-type retainers, tab-type retainers, removable retainers, etc.), and any of a plurality of retainers (e.g., 1, 2, 3, 4, or 5 or more retainers) can be formed, some of which can be formed by the tray 3900B itself. As shown, in fig. 39C, the first portion 3910 of the tray 3900B may include at least 3 tapered cylindrical holders equidistant from the side of the tray 3900B adjacent to the sterile water syringe 3892.

Fig. 39D shows a view of a medical procedure tray 3900C including a plurality of holders in a second configuration, according to some embodiments.

The medical procedure tray 3900C of fig. 39D may have a configuration similar to the medical procedure tray 3900B described with reference to fig. 39C. Thus, tray 3900C may likewise include a first portion 3910, a second portion 3920, and a third portion 3930, each of which may be configured to contain and hold contents for a medical procedure. However, as shown, first portion 3910 of tray 3900C may have a different configuration than first portion 3910 of tray 3900B. For example, first portion 3910 of tray 3900C of fig. 39D may similarly have at least 3 tapered cylindrical holders, one of which is indicated as holder 3912 and the other of which is indicated as holder 3913. However, at least one holder (e.g., holder 3913) of the at least 3 tapered post holders of tray 3900C may be offset from the other holders as shown by the dashed lines, as compared to the at least 3 tapered post holders equally spaced from the sides of tray 3900B. This different configuration may further limit the freedom of certain contents of the medical kit (e.g., sterile water syringe 3892) in the first portion 3910. Thus, this different configuration may further separate such certain contents of the first portion 3910 from certain other contents of the medical procedure in the first portion 3910.

Fig. 40A shows a view of another medical procedure tray 4000, according to some embodiments. Fig. 40B shows another view of the medical procedure tray 4000 of fig. 40A.

The medical procedure tray 4000 of fig. 40A and 40B may have a configuration similar to that of the medical procedure tray 3900A described with reference to fig. 39A and 39B. Thus, the tray 4000 can likewise include a first portion or first chamber 4010, a second portion or second chamber 4020, and a third portion or third chamber 4030, each of which can be configured to receive and retain contents for a medical procedure. However, as shown, second portion 4020 of tray 4000 may have a different configuration than second portion 3920 of tray 3900A. For example, the second portion 4020 of the tray 4000 may be an extension into the first portion 4010, while the second portion 3920 of the tray 3900A terminates at a common divider of both the second portion 3920 and the third portion 3930 of the tray 3900A, i.e., the first divider 3942. The extended second portion 4020 of the tray 4000 may be formed by an extended second divider 4044 extending into the first portion 4010 and terminating at a third divider 4046 in the first portion 4010 of the tray 4000. Further, the first divider 4042 separating the third portion 4030 from the first portion 4010 may terminate at an intermediate portion of the extended second divider 4044, rather than the inner wall of the tray 4000. With second portion 4020 configured as an extension portion, extended second portion 4020 may contain more contents, larger contents, or both, as desired for the medical procedure. As shown, the extended second portion 4020 includes a larger lubricant container 4094 than the lubricant container 3894 shown in fig. 39A and 39B.

Fig. 41A shows a view of another medical procedure tray 4100 according to some embodiments. Fig. 41B shows another view of the medical procedure tray 4100 of fig. 41A. Fig. 41C shows a third view of the medical procedure tray 4100 of fig. 41A.

The medical procedure tray 4100 of fig. 41A, 41B, and 41C can include a first portion 4110, a second portion 4120, and a third portion 4130, each of which can be configured to receive and hold contents for a medical procedure. As described herein, a portion of a medical procedure tray may be designated for one or more specific uses, andone portion may be at least partially (e.g., second portion 4120) and up to completely (e.g., third portion 4130) separated from one or more other portions by one or more physical features (e.g., one or more dividers) to form a chamber for one or more particular uses. As shown, the tray 4100 includes a first divider 4142 and a second divider 4144 that completely separate the third portion 4130 from the first portion 4110 and the second portion 4120. Further, the second separator 4144 partially separates the second portion 4120 from the first portion 4110. Like the medical procedure tray 3800 of fig. 38A and 38B, the first divider 4142 of the tray 4100, or at least the first portion of the first divider 4142, facing face may have a first height h_iAnd a second height h₂(see fig. 41B), and the second separator 4144 or at least the face of the second separator 4144 facing the third portion may have a first height (not shown). Unlike the tray 3800 of fig. 38A and 38B, the first height of the first divider 4142 and the first height of the second divider 4144 are shown to be less than the height of the medical procedure tray 4100. Further, a height of a face of the second separator 4144 facing the second portion may be equal to a height of a face of the second separator 4144 facing the third portion, such that a bottom of the second portion 4120 is coplanar with a bottom of the first portion 4110 or a bottom of the tray 4100. (see FIG. 41B.)

With respect to the first portion 4110 of the tray 4100, the first portion 4110 may be configured to contain a first set of contents for a medical procedure, such as catheterization. As previously described, the first set of contents may include, but is not limited to, a drainage system including a catheter (e.g., a Foley catheter), a drainage tube, a drainage bag, and a sterile water syringe 3892 for inflating a balloon of the Foley catheter. For visual reference, sterile water syringe 3892 is shown mounted in or on a holder (e.g., a rack-type holder) of first portion 4110, which is of a different type than the holders (e.g., tapered cylindrical holders) described with reference to tray 3900B of fig. 39C and 3900C of fig. 39D, respectively. Like the plurality of holders of

trays

3900B and 3900C, the holder for sterile water syringe 3892 may be formed from the tray 4100 itself and configured to hold the sterile water syringe 3892 in the first portion 4110 separate from the other contents of the medical kit in the first portion 4110. Sterile water syringe 3892 may simply be located in a holder or rack, or sterile water syringe 3892 may be interference fit into a holder or rack in a loose fit around sterile water syringe 3892.

With respect to the second portion 4120 of the tray 4100, the second portion 4120 can be configured to accommodate a second set of contents for a medical procedure, such as catheterization. As previously described, the second set of contents may include, but is not limited to, a container containing a lubricant (e.g., a lubricant for Foley catheter), such as lubricant syringe 4194. For visual reference, the lubricant injector 4194 is shown mounted in or on a retainer 4114 (e.g., a rack-type retainer) similar to that described with reference to the retainer in the first portion 4110 of the sterile water injector 3892. The lubricant injector 4194 may simply be located in the holder or bracket 4194 or the lubricant injector 4194 may be fitted into the holder or bracket 4194 with a loose-fit type interference fit around the lubricant injector 4194.

The holder 4194 and the holder for the sterile water syringe 3892 may be the same size or different sizes as the size of the lubricant syringe 4194 and the size of the sterile water syringe 3892 required for a medical procedure, as desired. When the lubricant injector 4194 and sterile water injector 3892 are the same size, the holder or rack for them may be the same size and the lubricant injector 4194 and sterile water injector 3892 may be exchanged for their placement in the medical procedure package, for example, to better coordinate the steps of the medical procedure. Thus, the second portion 4120 is not limited to receiving and retaining the lubricant injector 4194 and the first portion 4110 is not limited to receiving and retaining the sterile water injector 3892. The second portion 4120 may be configured to receive and retain a sterile water injector 3892, and the first portion 4110 may be configured to receive the lubricant injector 4194 even though the lubricant injector 4194 and the sterile water injector 3892 are different sizes.

With respect to the third portion 4130, the third portion 4130 includes a swab chamber 4132, an overflow chamber 4134, and a corner storage chamber 4136, as described herein, configured to contain a third set of contents for a medical procedure such as catheterization. As previously described, the third set of contents may include, but is not limited to, a sample container, optionally a label for the sample container, and a skin preparation kit including a disinfectant package (e.g., an iodophor, such as povidone-iodine, iodine tincture, aqueous iodine, etc.) and one or more swabs. 41A, 41B, and 41C the medical procedure tray 4100 is shown without a sample container or skin preparation kit for which the third portion 4130 is configured; however, fig. 8, 26, and 27 provide a visual reference in the swab chamber 4132 including the one or more swabs 34, fig. 25-29 provide a visual reference in the corner storage chamber 4136 including the sample container 54, and fig. 25 provides a visual reference in the medical procedure tray 4100 including the sterilant packet 52 above the swab chamber 4132 and overflow chamber 4134.

Focusing on fig. 41C, a medical procedure tray 4100 is displayed with a lid 4101, such as the packaging label 62 described with reference to fig. 11 and 12, the identification lid 120 described with reference to fig. 30A, or a combination thereof. As shown, the lid 4101 can be configured to fit over the entire medical procedure tray 4100; however, the cover 4101 may alternatively be configured to fit over a portion of the medical procedure tray 4100, including any one or more portions selected from the first portion 4110, the second portion 4120, and the third portion 4130. The lid 4101 may alternatively be configured to fit within the medical procedure tray 4100 in any of the aforementioned configurations, such as fitting within the entire medical procedure tray 4100 or a portion of the medical procedure tray 4100. (see, e.g., the cover 3801 of fig. 38C and 38D.) as further shown, the tray 4100 may be configured with an optional support 4102 in the first portion 4110 of the tray 4100. When one or more medical packages are stacked on a medical package that includes the medical procedure tray 4100 and lid 4101, the support 4102 can prevent sagging of the lid 4101 and damage to the contents below the tray 4100. The support may be configured to have a height substantially equal to the height of the tray 4100 and a width sufficient to withstand the weight of one or more medical packages stacked on the support.

Fig. 42A shows a view of another medical procedure tray 4200 according to some embodiments. Fig. 42B shows another view of the medical procedure tray 4200 of fig. 42A.

The medical procedure tray 4200 of fig. 42A and 42B may have a configuration similar to the medical procedure tray 4100 described with reference to fig. 41A and 41B. Thus, the tray 4200 may likewise include a first portion 4210, a second portion 4220, and a third portion 4230, each of which may be configured to receive and retain contents for a medical procedure. For example, the first portion 4210 may be configured to contain a first set of contents previously described for catheterization including a drainage system including a catheter (e.g., a Foley catheter), a drainage tube, a drainage bag, and a sterile water syringe 3892 for inflating a balloon of the Foley catheter. For visual reference, sterile water syringe 3892 is shown mounted in or on a rack-type retainer of first portion 4210. Further, the first portion may be configured with optional supports 4202A to prevent sagging of a cover placed thereon or over as described herein. For example, the second portion 4220 may be configured to contain a second set of contents previously described for catheterization including a container containing a lubricant (e.g., a lubricant for Foley catheter), such as lubricant syringe 4194. For visual reference, the lubricant injector 4194 is shown mounted in or on the cradle-type retainer 4214 of the second portion 4220. For example, the third portion 4230 may be configured with a swab chamber 4232, an overflow chamber 4234, and a corner storage chamber 4236, as described herein, configured to hold a third set of contents for catheterization, including a sample container, optionally a label for the sample container, and a skin preparation kit including a disinfectant package (e.g., an iodophor, such as povidone-iodine, iodine tincture, aqueous iodine, etc.) and one or more swabs.

However, with respect to the third portion 4230, the third portion 4230 of the tray 4200 may have a configuration that is different from the third portion of any of the

trays

3800, 3900A-C, 4000, and 4100, for example, in that at least the orientation of the third portion 4230 of the tray 4200 is in an opposite orientation relative to any of the other previously described trays. For example, third portion 3830 of tray 3800 is oriented such that well 3831 of swab chamber 3832 or the well end of third portion 3830 is adjacent to second portion 3820 of tray 3800. In this orientation, corner storage chambers 3836 share an inner wall of tray 3800 with tray 3800. In contrast, the reverse orientation of the third portion 4230 of the tray 4200 is such that the well (not shown) of the swab chamber 4232 or the well end of the third portion 4230 shares the inner walls of the tray 4200 with the tray 4200. In this orientation, the corner storage compartments 4236 are adjacent to the second portion 4220 of the tray 4200. Any one or more of the trays provided herein (including any one or more trays selected from

trays

3800, 3900A-C, 4000, and 4100) can be configured with a third portion of opposite orientation.

Focusing on fig. 42B, the medical procedure tray 4200 is displayed with a lid 4201, such as the package label 62 described with reference to fig. 11 and 12, the identification lid 120 described with reference to fig. 30A, or a combination thereof. As shown, the cover 4201 may be configured to fit over the entire medical procedure tray 4200; however, the cover 4201 may alternatively be configured to fit over a portion of the medical procedure tray 4200, including any one or more portions selected from the group consisting of the first portion 4210, the second portion 4220, and the third portion 4230. The lid 4201 may alternatively be configured to fit within the medical procedure tray 4200 in any of the aforementioned configurations, such as within the entire medical procedure tray 4200 or a portion of the medical procedure tray 4200. (see, e.g., the cover 3801 of fig. 38C and 38D.) as further illustrated, the tray 4200 can be configured with an optional support 4202B in the first portion 4110 of the tray 4100, the support 4202B being illustrated in a different location of the first portion 4110 than the optional support 4202A of fig. 42A. The location of the

optional supports

4202A and 4202B may vary depending on packaging needs and stacking needs. Further, when one or more medical packages are stacked on a medical package comprising the medical procedure tray 4200 and the lid 4201, a support such as the support 4202B may prevent sagging of the lid 4201 and damage to the contents under the tray 4200. Each of the

supports

4202A and 4202B may be configured to have a height substantially equal to the height of the tray 4200 and a width sufficient to bear the weight of a stack of one or more medical procedure packages stacked on the supports.

Fig. 43 shows a view of another medical procedure tray 4300, according to some embodiments.

The medical procedure tray 4300 of fig. 43 may have a configuration similar to the medical procedure tray 4200 described with reference to fig. 42A and 42B. Thus, the tray 4300 can likewise include a first portion 4310, a second portion 4320, and a third portion 4330 in the opposite orientations described with reference to the tray 4200. Each of first portion 4310, second portion 4320, and third portion 4330 may be configured to contain and hold contents for a medical procedure. For example, the first portion 4310 may be configured to contain the first set of contents previously described for catheterization including a drainage system including a catheter (e.g., a Foley catheter), a drainage tube, a drainage bag, and a sterile water syringe for inflating a balloon of the Foley catheter. Although not shown, the first portion 4310 may be configured with a tab-type retainer to hold or otherwise secure a sterile water syringe. For example, the second portion 4320 can be configured to contain a second set of contents for catheterization, previously described, including a container containing a lubricant (e.g., a lubricant for a Foley catheter) that can be retained or otherwise secured in the second portion 4320 by a tab-type retainer 4314 in the second portion 4320. For example, the oppositely oriented third portion 4330 may be configured with a swab chamber 4332, an overflow chamber 4334, and a corner storage chamber 4336, configured as described herein to accommodate a previously described third set of contents for catheterization including a sample container, optionally a label for the sample container, and a skin preparation kit including a disinfectant package (e.g., an iodophor, such as povidone iodine, iodine tincture, aqueous iodine, etc.) and one or more swabs. Similar to the tray 4200 of fig. 42A and 42B, the corner storage chambers 4336 are adjacent to the second portion 4320 of the tray 4300; however, the second portion 4320 of the tray 4300 extends from the inner wall of the first portion 4310 of the tray 4300 all the way to the inner wall of the opposite side of the tray 4300 shared by the third portion 4330, which is not the case with the second portion 4220 of the tray 4200. That said, the second portion 4220 of the tray 4200 may be configured to also extend from an inner wall of the first portion 4210 of the tray 4200 all the way to an inner wall of the opposite side of the tray 4200 shared by the third portion 4230.

Fig. 44A shows a view of removable retainers 4412 on a divider or side of a medical procedure tray, according to some embodiments. Fig. 44B shows another view of a removable holder 4412 on a divider or side of a medical procedure tray with a hidden instruction label according to some embodiments. Fig. 44C shows another view of a removable retainer on a divider or side of a medical procedure tray having an overt instruction label according to some embodiments.

Any of the medical procedure trays provided herein optionally include any number of any type of holder selected from: at least a cylindrical or tapered cylindrical retainer, a stent-type retainer, and a tab-type retainer to retain certain contents of the medical procedure kit in the appropriate section. For example, the tray 3900A may include three tapered cylindrical holders that provide the tray 3900B, wherein the three tapered cylindrical holders hold or otherwise continuously separate the sterile water syringe 3892 in the first portion 3910 from other contents of the medical kit (including other contents in the first portion 3810). (see fig. 39C and holder 3912 holding syringe 3892 in first portion 3910.) additionally, any of the medical procedure trays provided herein may optionally include one or more add-on type holders for holding certain contents of a medical procedure package in the appropriate portion. For example, as shown in fig. 45, a sticker type retainer 4512 may include a clip portion 4593 for clamping a sterile water syringe 3892 (or lubricant container 3894) to the sticker type retainer 4512, and the sticker type retainer 4512 may include an attachment strap or belt portion 4514 for attaching the clip portion 4593 to a tray (e.g., one side of the tray as shown) or a lid (e.g., the underside of the lid). Instructions for one or more steps of the medical procedure may be printed or embossed on the visible surface of the band or band portion 4514.

Regardless of whether the medical procedure tray includes any of the aforementioned retainers (e.g., post or tapered post-type retainers, stent-type retainers, tab-type retainers, and add-on-type retainers), the medical procedure tray may include one or more removable retainers. One example of a removable holder is removable holder 4412 of fig. 44A, 44B, and 44C, which is configured to hold sterile water syringe 3892 and lubricant container 3894 separate from the other contents of the medical kit. However, it should be understood that the removable retainers are not limited to the removable retainers 4412. For example, the removable holder may be configured to hold only the sterile water syringe 3892 or only the lubricant container 3894. Further, the removable retainer may be configured to retain other contents of the medical procedure package in the respective portion.

As shown in fig. 44A, 44B, and 44C, a removable retainer, such as removable retainer 4412, can include a clip, such as clip 4414, for removably attaching the removable retainer to a divider or side of a medical procedure tray. The clip can be configured to clip the removable retainer on a divider or side of the medical procedure tray such that the removable retainer is either inside the medical procedure tray (e.g., packaged) or outside the medical procedure tray (e.g., when used during a medical procedure). The clip can be configured to clip the removable retainer onto the divider or side of the medical procedure tray with a clip force sufficient to limit slidable movement of the removable retainer along the side or divider of the medical procedure tray. Alternatively, the clip may be configured to allow such slidable movement. When the clips are configured to allow slidable movement of the removable retainers along the dividers or sides of the medical procedure tray, the removable retainers may be attracted or otherwise retained on the dividers or sides of the medical procedure tray using a lesser clamping force or other attracting means (captivating means) in addition to the clamping force until the removable retainers are intentionally removed.

Slidable movement of the removable holder may be used to reveal or hide a description of one or more steps of the medical procedure. As shown in fig. 44B, a removable holder, such as removable holder 4412, may be packaged inside a medical procedure tray, thereby hiding the fold-down instructional label for the one or more steps of the medical procedure. Although the illustrated fold-down label on the exterior of the medical procedure tray is shown in fig. 44B and 44C, the tray may alternatively be configured with a fold-down instruction label on the interior of the tray. Regardless of the exterior or interior configuration of the fold-down instruction label, the removable holder can be slid aside as shown in fig. 44B to reveal the instruction shown in fig. 44C, which can be printed or embossed on the label. The legend may be hidden again by pushing the legend label inward or outward of the tray and sliding the removable holder over it. Hiding the description in the fold-down label may reduce the amount of information that a healthcare provider needs to know to only the information that is immediately needed to perform one or more immediate steps of a medical procedure. This may thereby reduce errors in the medical procedure. In addition, the folded-down instructional label may further conceal the sharp edges of the label that may otherwise compromise the sterile package if left in the unfolded or extended position.

Further, the removable holder 4412 of fig. 44A, 44B, and 44C is an embodiment of a removable holder configured to hold the sterile water syringe 3892 and lubricant container 3894 separate from the other contents of the medical kit. As shown in fig. 44A, 44B, and 44C, the removable retainer 4412 may include another wider clip (e.g., wider than clip 4414) configured with a first clip portion 4493 for gripping the sterile water syringe 3892 and a second clip portion 4495 for the lubricant container 3894. The first and

second clip portions

4493 and 4495 may have the same size as each other or different sizes from each other depending on the sizes of the sterile water syringe 3892 and the lubricant container 3894. Regardless, the sterile water syringe 3892 and the lubricant container 3894 may be arranged in the removable holder 4412 in synchronization with one or more steps of a medical procedure. For example, instructions for the one or more steps of the medical procedure may suggest connecting sterile water syringe 3892 to the Foley catheter in a first step, and the instructions may suggest lubricating the Foley catheter in a second step.

While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. Additionally, where methods and steps described above indicate certain events occurring in a certain order, those of ordinary skill in the art will recognize that the order of certain steps may be modified and that such modifications are in accordance with the variations of the present invention. In addition, certain steps may be performed concurrently in a parallel process where possible, or may be performed sequentially as described above. Therefore, to the extent there are variations of the invention that are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is intended that this patent will also cover such variations.

Claims

1. A urinary catheterization kit comprising:

a tray comprising a first portion, a second portion, and a third portion,

wherein one or more dividers separate at least the third portion from the first portion, the second portion;

a drainage system comprising a catheter, a drainage tube, and a drainage bag;

a sterile water injector is used for injecting sterile water,

wherein at least the first portion is configured to house the drainage system and the sterile water syringe;

a container for containing a lubricant, wherein the lubricant is contained in the container,

wherein at least the second portion is configured to receive the lubricant-containing reservoir, and

wherein

i) The bottom of the first portion is further from the top of the tray than the bottom of the second portion,

ii) each of the first and second parts comprises a holder along opposite longitudinal sides of the tray for holding the sterile water syringe and the container containing lubricant, respectively, or

iii) both i) and ii); and

a skin preparation kit comprising a disinfectant pack and one or more swabs, wherein:

at least the third portion is configured to receive the skin preparation kit, and

the tray includes catheterization instructions directly imprinted on the tray, at least some of which are revealed in synchronization with the steps of the catheterization.

2. The urinary catheter package of claim 1, wherein the bottom of the first portion is further from the top of the tray than the bottom of the second portion.

3. The urinary catheter package of claim 1 or claim 2, wherein:

a second portion separating divider of the one or more dividers further separates the second portion from the first portion, and

the second portion separating divider has a maximum height substantially equal to the height of the tray.

4. The urinary catheter package of claim 1, wherein each of the first and second portions comprises the retainers along opposite longitudinal sides of the tray for retaining the sterile water syringe and the lubricant-containing container, respectively.

5. The urinary catheter package of claim 1 or claim 4, wherein:

a second portion separating divider of the one or more dividers further separates the second portion from the first portion,

the second portion separating divider has a maximum height substantially smaller than the height of the tray, and

the bottom of the first portion is coplanar with the bottom of the second portion.

6. The urinary catheter package of any one of claims 1-5, wherein the third portion comprises:

a swab chamber comprising a well and one or more channels configured to respectively retain the one or more swabs therein using snap tabs;

an overflow chamber fluidly connected to the well by the one or more channels, the one or more channels further configured to deliver the disinfectant poured therein to the well; and

a corner storage chamber configured to receive a sample container.

7. The medical kit of claim 6, wherein the one or more channels are angled relative to a bottom of the tray such that a handle end of each of the one or more swabs when held under the snap tab is elevated relative to the absorbent head end when the absorbent head end is in the well.

8. The urinary bag of any one of claims 1-7, wherein a third portion of the one or more dividers at the well end of the swab chamber directly separates the well from the second portion with a divider.

9. The urinary bag of any one of claims 1-7, wherein the well end of the swab chamber shares an inner wall of one of the longitudinal sides of the tray with the tray.

10. The urinary bag of any one of claims 1-9, further comprising a support in the first portion, wherein the support has a height substantially equal to the height of the tray and a width sufficient to bear the weight of one or more urinary bags stacked on the support.

11. The urinary catheter package of any one of claims 1-10, further comprising:

an aseptic wrap having a folded configuration around the tray;

a perineal care kit packaged with the tray outside the sterile wrap;

a belly band external to the sterile wrap for maintaining the sterile wrap in the folded configuration around the tray, wherein the belly band includes instructions on how to orient the tray prior to opening the sterile wrap; and

a package label external to the sterile wrap identifying the urinary catheterization package, wherein the package label includes information that emphasizes key features of the urinary catheterization package in an easily and quickly readable manner.

12. A urinary catheterization kit comprising:

a tray comprising a first portion, a second portion, and a third portion,

a drainage system comprising a Foley catheter, a drainage tube, and a drainage bag;

a sterile water syringe for inflating a balloon of the Foley catheter, wherein at least the first portion is configured to house the drainage system and the sterile water syringe;

a container containing a lubricant for the Foley catheter, wherein:

wherein:

iii) both i) and ii); and

a skin preparation kit comprising a disinfectant pack and one or more swabs,

wherein the third portion comprises:

a corner storage chamber, wherein the third portion is configured to receive the disinfectant package over the wiper chamber, the overflow chamber, the corner storage chamber, or a combination thereof, and

wherein the tray includes catheterization instructions directly imprinted on the tray, at least some of which are revealed in synchronization with the steps of the catheterization.

13. The urinary catheter package of claim 12, wherein:

the bottom of the first portion is further from the top of the tray than the bottom of the second portion,

14. The urinary catheter package of claim 12, wherein:

each of the first and second parts comprises the holders along opposite longitudinal sides of the tray for holding the sterile water syringe and the container containing the lubricant, respectively, and

15. The urinary catheter package of claim 1 or claim 14, wherein:

the second portion separating divider has a maximum height substantially less than a height of the tray.

16. A medical procedure package comprising:

a tray comprising a first portion, a second portion, and a third portion, wherein one or more dividers separate at least the third portion from the first portion, the second portion;

a first set of contents for a medical procedure, wherein at least the first portion is configured to contain the first set of contents;

a second set of contents for use in the medical procedure,

wherein at least the second portion is configured to contain the second set of contents, and

wherein:

ii) each of the first and second portions comprises retainers along opposite longitudinal sides of the tray for retaining at least some of the first and second sets of contents for the medical procedure, respectively, or

iii) both i) and ii); and

a third set of contents for the medical procedure,

wherein at least the third portion is configured to contain the third set of contents, wherein the third portion comprises:

a swab chamber comprising a well and one or more channels configured to respectively retain one or more swabs therein using a snap tab;

an overflow chamber fluidly connected to the well by the one or more channels, the one or more channels further configured to communicate fluid poured therein to the well; and

corner storage chambers, and

wherein the tray includes medical procedure instructions directly imprinted on the tray, at least some of which are revealed in synchronization with the steps of the medical procedure.

17. The medical kit of claim 16, wherein:

the bottom of the first portion is further from the top of the tray than the bottom of the second portion, and

the one or more dividers have a maximum height substantially equal to the height of the tray.

18. The medical kit of claim 16, wherein:

each of the first and second portions includes the retainers along opposite longitudinal sides of the tray for retaining at least some of the first and second sets of contents, respectively, for the medical procedure, and

19. The medical kit of claim 16 or claim 18, wherein the one or more dividers have a maximum height that is substantially less than a height of the tray.

20. The medical kit of any one of claims 16-19, wherein:

the medical procedure is a catheterization procedure in which,

the first set of contents for the catheterization includes a drainage system including a Foley catheter, a drainage tube, a drainage bag, a sterile water syringe for inflating a balloon of the Foley catheter,

the second set of contents for the catheterization includes a container containing a lubricant for the Foley catheter,

the third set of contents for the catheterization comprises a skin preparation kit comprising a disinfectant pack and one or more swabs, and

the third portion is configured to receive the disinfectant package over the swab chamber, the overflow chamber, the corner storage chamber, or a combination thereof.