KR102622098B1 - Catheter insertion tray with integrated instructions - Google Patents

Abstract

An improved medical procedure or catheterization package included within an improved medical procedure or catheterization package is disclosed. An improved medical procedure or catheterization tray includes tools and instructions printed thereon and intuitively arranged to improve the outcome of a medical procedure or catheterization. In one example, the catheter insertion package and catheter insertion tray have a layout and/or arrangement of components that can reduce the incidence of catheter-related urinary tract infections by aiding ease of use and proper aseptic technique during insertion. A medical procedure or catheterization package and/or a medical procedure or catheterization tray comprising, for example, improved swabs, improved compartments for holding swabs essential and/or helpful for medical procedure or catheterization. , contains various tools, sections, and components.

Description

CATHETER INSERTION TRAY WITH INTEGRATED INSTRUCTIONS

This patent application relies on U.S. Provisional Patent Application No. 62/015,206, filed June 20, 2014, and U.S. Provisional Patent Application No. 61/891,496, filed Oct. 16, 2013, each of which is incorporated herein by reference in its entirety. Part of U.S. patent application 15/029,613, filed April 14, 2016, the U.S. domestic phase of international patent application PCT/US2014/060963, filed October 16, 2014, claiming priority to April 2017 Priority is claimed on US Patent Application No. 15/487,297, filed on the 13th.

Urine drainage systems are commonly used in hospitals and healthcare facilities when it is essential to assist, control, and monitor a patient's urination and when it is essential to collect urine from the patient. These urine drainage systems allow the patient to remain in bed without having to use the toilet or having to move to use the restroom. The urine drainage system consists of a catheter (e.g. an intermittent catheter or a urinary catheter such as a Foley catheter), a collection container/bag, for example made of polymer material or PVC film. bag), a urine meter, and tubing connecting the Foley catheter to a collection container/bag or urine meter and/or other equipment. During the procedure, the patient is first catheterized, and the catheter is connected to a drain container/bag and/or urine meter via a length of tubing (eg, drain tubing). Urine can be moved from the catheter to the collection bag by gravity only. On average, patients produce 80 to 90 mL of urine per hour.

Accurate monitoring of urine helps clinicians detect outliers in urine flow rate or volume, which can alert the clinician that the patient is experiencing a significant problem. However, urine output cannot be accurately measured if the drainage system attached to the Foley catheter is unreliable or the Foley catheter and drainage system are not used properly. Furthermore, hospitals are increasingly using low profile beds to reduce the number of injuries resulting from falls. With the application of low profile beds, the amount of allowable height to allow piping for discharge is reduced. Ventilation systems associated with exhaust pipes used in hospitals have also undergone changes/modifications. Ventilation combined with lower profile hospital beds has produced suboptimal exhaust performance. For example, urine has been observed pooling in pipes. This prevents accurate measurement of urine output and flow, which is important for many patients.

Currently, the second most common form of hospital acquired infection (HAI) is catheter-associated urinary tract infection (CAUTI). Hospitals are interested in ways to reduce their incidence of catheter-related urinary tract infections by following strict aseptic technique as the standard of care. However, many factors affect a hospital's ability to meet standards of care. These factors include: healthcare practitioner/nurse experience and training, patient factors (eg, general health, weight and anatomy), environmental factors and tray layout, contents and instructions/indicators. Catheterization trays and/or catheterization packages with procedure-optimized components and intuitive layouts can increase compliance with aseptic techniques, potentially reducing the incidence of catheter-related urinary tract infections.

In the healthcare field, there is a need for a reliable, safe, and easy method to insert urinary catheters, such as indwelling catheters or intermittent catheters, into patients. In particular, there is a need to provide catheter insertion trays (e.g., Foley catheter trays) and/or catheter insertion packages that standardize and improve processes for inserting urinary catheters, such as indwelling Foley catheters, into patients.

The present disclosure better meets the needs of patients, improves reliability and ease of use, reduces the incidence of catheter-related urinary tract infections, improves safety, and addresses other issues described above and elsewhere herein. Provided are drainage systems, catheter trays, and catheter insertion packages configured to handle.

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

The objectives described herein may be achieved by providing an improved medical procedure package and/or tray (eg, an improved catheterization package and/or an improved catheterization tray). An improved medical procedure package may include therein an improved medical procedure tray, and the medical procedure tray is intuitively arranged and contains instructions or procedural indicators to improve the implementation and outcome of the medical procedure. It can be included. A medical procedure package and/or medical procedure tray may include various tools and components that are essential and/or helpful in a medical procedure. For example, improved catheterization packages include improved catheterization trays, povidone iodine swabs and swabsticks that allow for greater coverage and saturation, and swabsticks that allow for better efficacy. It may include a hand sanitizer to enable hand use, tubing to break the surface tension of the fluid to improve discharge, and/or other components described herein.

According to various embodiments, the present disclosure provides catheter insertion trays and catheter insertion packages having an arrangement and/or layout of components that can help reduce the incidence of catheter-related urinary tract infections by aiding in ease of use and aiding in proper aseptic technique during insertion. provides. The present disclosure further provides methods of catheterization and the use of catheterization trays and/or catheterization packages that can assist in easier and more sterile catheterization, helping to reduce the incidence of catheter-related urinary tract infections. Additionally, the present disclosure provides methods that can improve discharge performance, resulting in (1) helping to remove fluid within the discharge piping, and (2) increasing the accuracy of urine measurements (e.g., measurements of output and flow). Provides a system.

In some embodiments, a catheterization package is provided including a catheterization tray and a sterile wrap surrounding the catheterization tray. The catheterization tray may include catheterization instructions printed directly on the catheterization tray. The catheterization tray may include a first section, a second section and a third section, with one or more partitions separating the third section from at least the first and second sections. The first section can hold the discharge system, the second section can hold the container containing the lubricant, and the third section can hold the swab in an inclined position. The absorbent head of the swab can be tilted toward the well of the third section and the elongated member of the swab can be tilted upward for gripping and removal of the swab.

In these embodiments, the catheterization package may further include a peri-care kit, a belly band, and a packaging label. Peri-Care Kits can be packaged with catheterization trays outside of sterile wrap. One example of a peri-care kit is disclosed in PCT Application Publication WO 2016/126555, the disclosure of which is incorporated herein by reference in its entirety. A belly band may be external to the sterile wrap, holding the sterile wrap in a folded configuration around the catheterization tray. A packaging label may be external to the sterile wrap for identification of the catheterization package.

In these embodiments, the third section of the catheterization package may include a corner storage compartment for holding a specimen container, an overflow compartment, and a swap compartment. The swap compartment may include channels and pits configured to contain swap. The channel includes at least two snap-in tabs for holding swap in the channel below the snap-in tabs, where each longitudinal side of the channel includes at least one of the at least two snap-in tabs. Channel The silver swabs may be further configured to convey fluid to the pit when the swabs are not in the channel and fluid is poured into the channel. The overflow compartment may be fluidly connected to the pit via a channel.

In such embodiments, one or more partitions of the catheterization package separating the third section from the first section and the second section may further separate the second section from the first section. The second section of the one or more partitions - the separating partitions may have the same maximum height as the catheterization tray, and the bottom of the second section may rise above the bottom of the catheterization tray. Alternatively, the second section separation partitions of the one or more partitions may have a maximum height that is less than the height of the catheterization tray, and the bottom of the second section and the bottom of the catheterization tray are substantially coplanar.

In some embodiments, a medical procedure package is provided including a tray with medical procedure instructions printed directly on the tray, with at least some of the instructions step by step in the steps of the medical procedure. The tray may include a first section, a second section, and a third section, and one or more partitions may separate at least the third section from the first and second sections. The tray may further include a discharge system, a container containing lubricant, and one or more swabs. The first section may include at least a discharge system, the second section may include at least a container containing a lubricant, and the third section may include at least one swab.

In these embodiments, the medical procedure package may further include a specimen container. The third section may include a corner storage compartment containing a swap compartment, an overflow compartment and a sample container. A swap compartment may include a pit and one or more channels configured to hold one or more swaps with snap-in tabs each in one or more channels. The one or more channels are angled relative to the bottom of the tray so that the handle end of one or more swabs is held under the snap-in tabs when the absorbent-head end is in the pit. It's coming up about. The overflow compartment may be fluidly connected to the pit through one or more channels, and the one or more channels may be further configured to convey fluid poured therein to the pit when one or more swabs are removed from the one or more channels.

In such embodiments, the medical procedure package may further include a third section-separating partition of one or more partitions, at a pit end of the swap compartment directly separating the second section from the pit. Alternatively, the pit end of the swap compartment may share an inner wall of the tray with the tray.

In such embodiments, one or more partitions of the medical procedure package separating the third section from the first and second sections may separate the second section from the first section. The second section of the one or more partitions may have a maximum height equal to the height of the tray, and the bottom of the second section may be raised above the bottom of the tray. Alternatively, the second section-separating partitions of one or more partitions may have a maximum height that is less than the height of the tray, and the bottom of the second section and the bottom of the tray are substantially coplanar.

In these embodiments, a catheterization package is provided including a tray with instructions for the catheterization procedure printed directly on the tray, with at least some of the instructions presented step by step along with the steps of the catheterization procedure. The tray may include a first section, a second section, and a third section, and one or more partitions may separate at least the third section from the first and second sections. The tray may further include a discharge system, a container containing a lubricant, a syringe of antiseptic solution (e.g., water or, in some examples, saline), and a skin preparation kit. The first section may include at least a drainage system, which may include a Foley catheter, drainage tubing, and a drainage bag. The second section may include a container containing at least a lubricant. The first section may include a syringe of a sterile solution, such as sterile water, which may be configured to inflate the balloon of the Foley catheter with sterile water. According to some embodiments, a water syringe may be connected to the inflation port of the Foley catheter during fabrication of the assembly. Providing a syringe pre-connected to the Foley catheter can help minimize the steps required to insert the catheter into the patient. The third section may include a skin preparation kit including at least one or more swabs and a package of preservative.

In these embodiments, the catheterization package may further include a specimen container and a label for the specimen container. The third section may include a corner storage compartment containing a swap compartment, an overflow compartment and a sample container. A swap compartment can be configured to each hold one or more swaps with snap-in tabs on one or more channels. The overflow section may be fluidly connected to the pit through one or more channels further configured to convey preservatives poured therein to the pit when one or more swabs from the one or more channels are removed. The package of preservative may be placed on a swap compartment, overflow compartment, corner storage compartment, or a combination thereof.

In such embodiments, the catheterization package may further include a third section-separating partition of one or more partitions at the pit end of the swap compartment directly separating the pit from the second section. Alternatively, the pit end of the swap compartment may share an inner wall of the tray with the tray.

In such embodiments, one or more partitions of the catheterization package separating the third section from the first and second sections may further separate the second section from the first section. The second section of the one or more partitions may have a maximum height equal to the height of the tray, and the bottom of the second section may be raised above the bottom of the tray. Alternatively, the second section-separating partitions of one or more partitions may have a maximum height that is less than the height of the tray, and the bottom of the second section and the bottom of the tray may be substantially coplanar.

In these embodiments, the catheterization package may further include a sterile wrap, peri-care kit, belly band, and packaging label. The sterile wrap may be in a folded configuration around the tray. Peri-Care kits can be packaged with a catheter tray outside of sterile wrap. The belly band may be external to the sterile wrap while holding the sterile wrap in a folded configuration around the catheterization tray. The belly band may include instructions on how to position the tray before opening the sterilization wrap. A packaging label may be placed on the outside of the sterile wrap to identify the catheterization package. Additionally, the package label may contain information that highlights key features of the catheterization package in an easy-to-read manner.

In some embodiments, the catheterization package includes a first compartment holding a drainage system; a second compartment holding a syringe; a third compartment containing the swab in an inclined position, such that the absorbent head of the swab is deflected downward into the pit of the third compartment and the elongated member of the swab is tilted upward for easy gripping and removal; and a catheterization tray including catheterization instructions or procedural indicators printed directly on the catheterization tray. In the catheter insertion package, the absorbent head of the swab wrapped around the circumference of the catheter insertion tray is formed of absorbent foam, and the elongated member of the swab may have a generally rectangular cross-section with rounded edges. there is. The catheterization package may further include a peri-care kit packaged with the catheterization tray in a location outside the sterile wrap. The catheterization package may further include a belly band outside the sterile wrap containing procedural indicators or instructions on how to position the catheterization tray prior to opening the sterile wrap. Additionally, the catheter insertion package includes at least three sides that fold into different planes from the upper portion of the label visible when viewing the catheter insertion package from one or more sides of the catheter insertion package and/or in a manner that is easily readable. A package label outside the sterilization wrap may be included that includes information features (e.g., information squares) that highlight each key feature. The catheterization package may include an external sealed container or bag (e.g., plastic, clear bag) around the other components to maintain sterility during transportation and storage.

In some embodiments, a medical procedure package includes tools useful for performing a medical procedure, arranged so that the medical procedure proceeds intuitively according to the step-by-step arrangement, and instructing the user how to perform the steps of the medical procedure. The medical procedure may include instructions/procedure indicators printed or included directly on the tray. Arrangement of different components and tools (e.g. 2 to 20 tools/components or 4 to 10 tools/components) to be used (e.g. a component to be used before other components or tools) Components or tools may involve stacking them on top of each other (so that they are placed on top of other components or tools to be used later).

In some embodiments, a method of treating a patient includes a medical procedure tray comprising three or more compartments containing tools useful for performing a medical procedure and instructing a user how to perform the steps of the medical procedure. Includes providing instructions/procedural indicators printed directly on the procedure tray. The method may include performing a medical procedure on a patient while following instructions/procedural indicators printed on a medical procedure tray. Three or more compartments of a medical procedure tray, instructions/procedure indicators and/or tools can be used to intuitively proceed step by step with a medical procedure based on how they are arranged on/in the medical procedure tray. are arranged so that

In some embodiments, inserting a catheter into a patient includes: a first compartment containing a drainage system containing the catheter; A catheter insertion package having a catheter insertion tray comprising a second compartment containing the swab in an inclined position, the absorbent head of the swab being deflected downward into a cavity of the second compartment and the elongated member of the swab being tilted upward. and pouring the sterile solution into the cavity so that the absorbent head comes into contact with the sterile solution, using a swab to clean the area where the patient's catheter will be inserted, and inserting a portion of the catheter into the patient's bladder. A sealed container or sealed bag can be placed around the catheterization tray, and the method can include opening the sealed container or sealed bag. Sterile wrap may be wrapped around the catheterization tray, and the method may include removing the sterile wrap prior to pouring the sterile solution into the cavity. The catheterization package may include a peri-care kit positioned outside the sterile wrap, and the method may include using the peri-care kit to clean the perineal area of the patient prior to removing the sterile wrap. The belly band may be positioned outside the sterile wrap, and the belly band may include an instruction/procedural indicator or instructions/procedure indicators regarding how to properly position the catheterization tray before opening the sterile wrap, The method may include placing the tray according to instruction(s)/procedural indicator(s) prior to removing the sterilization wrap.

In some embodiments, a method of manufacturing a catheterization package includes directly inserting a catheter into a first compartment, a second compartment, a third compartment with an angled portion of the bottom of the compartment having channels for containing swabs, and a catheter insertion tray. and providing a catheterization tray comprising printed catheterization instructions/procedural indicators, wherein each of the first compartment, second compartment, and third compartment is at least partially separated from one another by a partition. . This method involves positioning the drainage system in the first compartment, the syringe in the second compartment, and the swab in the third compartment so that the absorbent head of the swab is deflected downward toward the pit of the third compartment and the elongated end of the swab This may include positioning the member so that it is angled upward for easier gripping and removal. This method involves wrapping a sterile wrap within a catheterization tray and using a belly band containing instructions/procedural indicators or instructions/procedural indicators related to how to properly position the catheterization tray before opening the sterile wrap. and placing around a portion of the sterile wrap. Additionally, this method includes a peri-care kit containing a zippered compartment containing cleaning towelettes, hand sanitizer, and instructions/procedural indicators for cleaning the patient, on the outside of the belly band and sterilization wrap. This may include adding to a catheterization tray. The method may include adding documentation of specific catheterization instructions and/or procedural indicators to the catheterization package. The method may also include placing on the top of the catheterization package a packaging label that includes at least three side portions folded from the upper portion and/or each containing information features or in a quickly readable manner, one or more main portions of the catheterization package. This may include placing a packaging label on top of the catheterization package that highlights features. The information feature or information features may be an information square or multiple information squares. The method may further include sealing (eg, by heat sealing) a clear plastic bag around the catheterization package.

In some embodiments, the catheterization system includes a container to protect components for the catheterization procedure. A container has an outer shell that defines the general shape of the container and has a plurality of compartments within the outer shell. Each of the plurality of compartments is separated from one or more adjacent compartments of the plurality of compartments by one or more partitions. The plurality of compartments includes a first compartment configured and sized to contain a catheter assembly and one or more auxiliary compartments separated from the first compartment by one or more partitions. At least one of the one or more auxiliary partitions includes at least one partial partition (eg, a partition comprising a reduced height portion) of the one or more partitions.

In some embodiments, a catheterization system is provided for performing a catheterization procedure. The catheterization system includes a catheterization tray having an outer shell defining the general shape of the container and a plurality of compartments within the outer shell. Each of the plurality of partitions is separated from one or more adjacent partitions of the plurality of partitions by one or more partitions. The plurality of compartments may include a first compartment containing a catheter assembly and one or more auxiliary compartments separated from the first compartment by one or more partitions. At least one of the one or more auxiliary partitions may include a partial partition (eg, a partition including a reduced height portion) of at least one of the one or more partitions. Additionally, the catheterization system includes one or more swabs located in a second one of the one or more auxiliary compartments.

The disclosed embodiments of packages, trays, devices, systems and methods and extensions therefor may be better understood with reference to the following drawings. Portions of the content of this patent document are protected by copyright under the copyright laws of the United States and other countries. The owner of the copyright has no objection to the copying by any person of the patent document or patent disclosure as it appears in publicly available files or records of the United States Patent and Trademark Office, but otherwise retains all copyright rights.
1 shows a top view of a medical procedure tray containing integrated instructions/procedural indicators in the form of a catheterization tray.
Figure 2 shows a top, front (or proximal), right perspective view of the medical procedure tray of Figure 1;
Figure 3 shows a right front view of the medical procedure tray of Figure 1;
Figure 4 shows a posterior (or distal) front view of the medical procedure tray of Figure 1;
Figure 5 shows a top view of another medical procedure tray with integrated instructions/procedural indicators in the form of a larger catheterization tray than the tray in Figure 1.
Figure 6A shows a top view of a swab or swabstick that may be included in a catheterization package and/or tray.
Figure 6B shows a side perspective view of the swap or swapstick in Figure 6A.
FIG. 6C shows a cross-sectional view of the swap or swap stick in FIG. 6A to illustrate the cross-sectional shape of the elongated member of the stick.
Figure 7A shows a top view of a swab or swab stick that may be included in a catheterization package and/or tray.
Figure 7b shows a side perspective view of the swap or swap stick in Figure 7a.
FIG. 7C shows a cross-sectional view of the swap or swap stick in FIG. 7 to illustrate a cross-sectional view of the elongated member or stick, different from the cross-sectional shape shown in FIG. 6C.
8 shows a swab of a catheterization tray, similar to the swab or swab stick shown in FIGS. 7A-7C, with one swab or swab stick rotated about 90 degrees to release it from the protective features of the swab compartment. Shows top views of compartments and small storage or overflow compartments.
Figure 9 shows a top view of a catheterization package sealed in a hermetic bag and having a packaging label with an information square on the top thereof and on both sides providing easy visibility even when stacked with other catheterization packages.
10 shows a catheterization package sealed in a seal bag and having a packaging label with an information square on the top thereof and on two sides (one side visible) providing easy visibility even when stacked with other catheterization packages. shows a top view (different from that shown in Figure 9).
Figure 11 shows the catheterization package of Figure 9 outside the sealed bag and still having the same packaging label thereon.
FIG. 12 is a top view of the packaging label of the catheterization package of FIG. 10 including added lines to show where the sides are folded over other components of the catheterization package prior to sealing the catheterization package in a sealing bag.
FIG. 13 shows a catheter insertion package (catheter insertion of FIG. 9 or FIG. 10 ) showing specific instructions/procedural indicators or Directions for Use (DFU) after the seal bag and package label have been removed and thereon. One of the packages) is shown.
FIG. 14A illustrates a page of specific catheterization instructions/procedural indicators or Directions for Use (DFU) document that may be included in a catheterization package.
FIG. 14B shows another page of the specific instructions/procedural indicators or Directions for Use (DFU) document of FIG. 14A.
Figure 14C shows another page of the Specific Instructions/Procedural Indicators or Directions for Use (DFU) document of Figure 14A.
Figure 14D shows another page of the Specific Instructions/Procedural Indicators or Directions for Use (DFU) document of Figure 14A.
Figure 15A shows the front of a patient education information sheet/pamphlet that may be included in a catheterization package.
Figure 15B shows the back of the patient education information sheet/pamphlet of Figure 15A.
FIG. 16 shows a top view of the catheter insertion package of FIG. 13 showing a label or insert sheet thereon, without a document or Directions for Use (DFU) document with specific instructions/procedural indicators.
FIG. 17 shows a top view of a catheter insertion package (e.g., similar to the catheter insertion package of FIG. 16) showing a perineal treatment or peri-care kit/packet thereon, without a label or insertion sheet.
FIG. 18 shows a top view of a catheter insertion package (e.g., similar to the catheter insertion package of FIG. 16), without a label or insertion sheet, showing another perineal treatment or peri-care kit/packet thereon.
Figure 19 shows a separated view of components of the perineal care (or peri-care) kit or packet of Figure 18.
Figure 20 is a catheterization package (e.g., the catheterization package of Figures 17 or 18 and A top view (similar) is shown.
FIG. 21 shows a top view of a catheterization package (similar to the catheterization package of FIG. 20 or FIG. 21 ) without the belly band and showing the sterile wrap only partially folded/wrapped around the catheterization tray.
22 shows the sterile wrap fully unfolded but remaining under the catheter insertion tray and the contents of the catheter insertion tray before any components are removed, or the contents of the catheter insertion tray during production/packaging, with all components required to be in the sterile wrap inside. A top view of the catheterization package of FIG. 22 is shown showing the contents of the catheterization tray after being placed.
Figure 23 shows a top view of the catheterization package of Figure 23 with the package of sterile gloves partially unfolded and placed on top of the catheterization tray.
Figure 24 shows a top view of the catheterization package of Figure 24, without the package of sterile gloves, and showing the pad/drape (representing a waterproof underpad and/or fenestrated drape) placed on top of the catheterization tray.
FIG. 25 shows a top view of the catheterization package of FIG. 25 showing the pad/drape being moved in the swab compartment and the povidone-iodine solution positioned in the swab compartment and extending into the overflow compartment or mini-reservoir of the catheterization tray.
FIG. 26 is a top view of the catheterization package of FIG. 26 showing swabs or swab sticks in the swab compartment without povidone-iodine solution and with the proximal end of the sticks extending into a small reservoir or overflow compartment of the catheterization tray. It shows the degree.
Figure 27 shows a top view of the catheterization package of Figure 27 with a sterile solution syringe attached to the inflation port of the catheter.
FIG. 28 is a top view of the catheterization package of FIG. 28 with a distal portion of the catheter positioned in the syringe or catheter compartment and a syringe of lubricating jelly adjacent to the catheter or syringe compartment prepared to spray the lubricating jelly onto the distal end of the catheter or on top of the distal region. It shows the degree.
Figure 29 shows a top view of the catheterization package of Figure 29 after the catheter has been removed from the tray and inserted into the patient, with the outlet tubing extending toward the patient.
Figure 30A is a top view of the catheterization system.
Figure 30B is a top view of the catheterization tray of the catheterization system of Figure 30A wrapped.
Figure 31A is an isometric view of a catheterization tray with its contents.
Figure 31B is an isometric view of the catheterization tray of Figure 31A with some of its contents removed therefrom.
Figure 31C is a rear isometric view of the catheterization tray of Figure 31A.
Figure 32 is an isometric view of the catheterization tray of Figure 31A with all of its contents removed therefrom.
Figure 33 is a top view of the catheterization system.
Figure 34 is a top view of a glazed drape.
Figure 35 is an isometric view of the swap.
Figure 36A is an isometric view of the catheterization system.
Figure 36B is an isometric view of the catheterization tray of the catheterization system of Figure 36A.
Figure 37A is an isometric view of the catheterization system.
Figure 37B is an isometric view of a partially unfolded catheterization tray of the catheterization system of Figure 37A.
Figure 37C is a partial isometric view of an unfolded catheterization tray of the catheterization system of Figure 37A.
Figure 38A shows a diagram 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 with a cover.
FIG. 38D shows another view of the medical procedure tray of FIG. 38A with a cover.
Figure 39A shows a diagram 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 diagram of a medical procedure tray including multiple retainers in a first configuration according to some embodiments.
FIG. 39D shows a diagram of a medical procedure tray including multiple retainers in a second configuration according to some embodiments.
Figure 40A depicts another medical procedure tray according to some embodiments.
Figure 40B shows another embodiment of the medical procedure tray of Figure 40A.
Figure 41A shows a diagram of another medical procedure tray according to some embodiments.
FIG. 41B shows another view of the medical procedure tray of FIG. 41A.
Figure 41C shows another view of the medical procedure tray of Figure 41A.
Figure 42A shows a diagram of another medical procedure tray according to some embodiments.
Figures 42B and 42C show different views of the medical procedure tray of Figure 42A.
Figure 43 shows a diagram of another medical procedure tray according to some embodiments.
Figure 44A shows a diagram of a removable retainer on a side or partition of a medical procedure tray according to some embodiments.
FIG. 44B shows another view of a removable retainer on a partition or side of a medical procedure tray with tabs for hidden instructions according to some embodiments.
FIG. 44C shows another view of a removable retainer on the side or partition of a medical procedure tray with tabs exposing instructions according to some embodiments.
Figure 45 shows a diagram of an appendage-type retainer on the side of a medical procedure tray according to some embodiments. Although the invention is susceptible to various modifications and alternative configurations, specific embodiments thereof are shown by way of example in the drawings and are specifically described herein. However, the specific embodiments described herein are not intended to limit the invention to the specific form disclosed, but are intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. It has to be.

The following description and accompanying drawings, which illustrate and illustrate particular embodiments, refer in a non-limiting way to medical procedure packages, medical procedure trays, catheter insertion packages, in accordance with various aspects and features of the present disclosure; It is intended to illustrate catheterization trays and associated components, assemblies and systems, etc., and various methods of producing and using them.

Described herein are various packages, kits, trays, systems, assemblies, devices and methods, including those used in various medical procedures (including, for example, catheterization procedures). Although specific embodiments are described herein by way of example, the described embodiments and examples are not intended to be limiting. Accordingly, for example, although aspects of the invention are described in terms of catheter insertion packages, catheter insertion trays, catheter insertion procedures, etc., the present disclosure does not refer to catheter insertion related packages, trays, systems/assemblies, procedures, etc. It is not limited to fields, 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, etc.

According to various embodiments, the objectives set forth above or elsewhere herein may be achieved, for example, by creating a medical procedure tray with a more intuitive or better organized layout, instructions/procedural indicators coupled to the tray. This can be achieved by providing an improved medical procedure package or kit comprising: For example, improved catheterization packages or kits may be provided to improve ease of use, improve adherence to proper technique, reduce the likelihood of infection, etc.

According to various embodiments, a medical procedure package may include a medical procedure tray therein. The medical procedure package may further include other components that are essential or helpful for the medical procedure. The medical procedure tray(s) contemplated herein may have a single level or multiple layers. Medical procedure tray(s) can have various shapes and sizes. For example, a medical procedure tray may have a generally or approximately rectangular, square, circular, oval, triangular, hexagonal, polygonal or other shape. As a non-limiting example, a generally rectangular medical procedure tray may have a length ranging from 7 inches to 20 inches, a width ranging from 4 inches to 12 inches, and a height ranging from 1 inch to 4 inches. In one embodiment, a generally rectangular medical procedure tray (e.g., a catheterization tray similar to that shown in Figures 1-4) is approximately 11 inches long, approximately 8.5 inches wide, and approximately 2 inches wide. It can have height. In one embodiment, a generally rectangular medical procedure tray (e.g., similar to the tray shown in Figures 5, 31-31C & 32C) is approximately 14 inches long, approximately 8.5 inches wide, and approximately 2.5 inches wide. It can have a height of inches.

The medical procedure tray may further include multiple sections of various shapes and sizes, with any section optionally forming a compartment. A compartment may be a section, at least partially and entirely, separated from one or more sections, compartments, or a combination thereof by physical features such as one or more partitions, whereas a section of a medical procedure tray may serve one or more specific purposes. may be designated for this (e.g. pits for iodine, sections for storage, etc.). Partitions may be formed from the medical procedure tray itself (e.g., formed during an injection molding process), and opposing sides of the partitions may further separate the compartments from other sections or compartments. The heights may be different if you have high or low elevation floors. The partitions may each be formed from the same material as the medical procedure tray or may be formed from a different material than the medical procedure tray. Partitions may also be temporarily formed from one or more other components essential or useful for a medical procedure until the one or more other components are removed from the medical procedure tray. For example, for components essential or useful for catheterization, one or more partitions may be temporarily formed from specimen or sample containers, instructions/procedural indicators, or other components essential or useful for catheterization as described herein. It can be. Like sections, compartments can have various shapes and sizes (eg, compartments can be any of the shapes described for the medical procedure tray itself or other shapes).

According to various embodiments, the medical procedure package may be a catheterization package containing one or more catheterization trays therein. For example, a catheterization package may include an improved catheterization tray with a more intuitive or better organized layout and/or instructions/procedural indicators included with the tray. Although various features are described below in terms of a catheterization package and/or catheterization tray, the features described may also apply to or be included in medical procedure packages and/or trays used for procedures other than catheterization.

The catheterization package may include any components essential or useful for catheterization. Some components useful for catheterization that may be included in the catheterization package include a drainage system, drainage/collection bag, drainage tubing, catheter (e.g., Foley catheter), drainage outlet, stabilization device (e.g., StatLock® Foley stabilization device from C. R. Bard, Inc.), urine meter, swabs or swab sticks, prepping balls (e.g., absorbent cotton balls), forceps, specimen or sample container, specimen A label affixed to the specimen or sample container and filled with specific details regarding the a syringe of jelly), a syringe of sterile solution (e.g., a 10 cc syringe of sterile solution to inflate the retention balloon of a Foley catheter), a fenestrated drape placed over the patient, and an underpad placed under the patient's buttocks. (e.g. waterproof absorbent underpad), gloves (e.g. packages of rubber gloves, latex gloves, latex-free gloves), sterilization wraps (e.g. CSR wraps), belly bands (e.g. sterilization wraps) (for placing the wrap in a folded configuration), perineal care packet, hand sanitizer (e.g., antiseptic gel hand rinse), moist towelette (e.g., package of castile soap towelettes), instructions/procedural indicators (e.g., instruction sheet for healthcare providers and/or instruction pamphlet for patients), checklist of safety precautions/steps, patient information chart, insert sheet, packaging label, outer container (e.g., sealed bag) ) and/or other components. Components included in a catheterization package may be included within one or more compartments of a catheterization tray, within a separate package or bag (eg, an extra-tray package), or in a second catheterization tray.

Catheterization trays can be labeled with step-by-step instructions/procedural indicators arranged in logical locations on the tray. Catheterization tray(s) may have a layout and design that makes the catheterization procedure more intuitive. A single-layer catheterization tray having a generally rectangular shape, containing multiple compartments of various shapes, having step-by-step instructions/procedure indicators, and having an improved layout is illustratively illustrated in FIGS. 1-4 and below. do. Other similar single-layer catheterization trays are also shown in Figures 5, 31A-31C, and 32.

According to various embodiments, for example as shown in Figures 1-5, the catheterization tray includes: a main compartment (1), a syringe or catheter compartment (2); swap compartment (3); Small storage or overflow compartment (4); and a corner storage compartment (5). The tray has stiffening ribs (e.g., stiffening ribs 20 shown in Figure 2; stiffening in Figures 31A-31C) that strengthen the tray and prevent it from bending (e.g. when held with one hand). Ning ribs (see further 205) may further be included.

1, 2 and 5, main compartment 1 is the largest compartment of the tray and contains the items required for catheterization, such as drainage system, collection bag, drape, underpad, inflation injection, and/ Alternatively, it may include any number of gloves. Drainage systems that may be included in the catheterization package and/or main compartment 1 include, for example, drainage/collection bags, drainage tubing, catheters (e.g., Foley catheters), drainage outlets, urine meters, and/or other May include exhaust system components. Drainage system components may be stored in a catheterization package pre-connected and pre-connected, or as individual components to be assembled/connected at a later date.

The drainage system and tubing included in the catheterization system may be arranged and configured in a manner to help improve the discharge of urine through the system and tubing. For example, piping or other components of a piping system may be designed to break the surface tension of a fluid to improve discharge. The discharge piping can be short to accommodate low bed profiles and can have adjustable lengths for different sized beds. Piping or other exhaust system components may include a coating thereon (e.g., a lubricant coating) to aid drainage therethrough. Optionally, piping or other venting system components may include a superhydrophobic pattern thereon to aid venting.

Additionally, there are appropriate durometer ranges for piping and other exhaust system components. However, for components that can be wrapped in a tray (eg drain tubing and/or catheters) it is desirable to have a tubing durometer that tends not to have a set shape at room temperature. For example, the durometer used for wrapped components may be tested with different durometers to ensure that there should be no tendency to leave the component in a rolled configuration when removed from the tray and used. It is advisable to give the discharge pipe a durometer such that, even if it is wrapped coiled in the main compartment, for example, the discharge pipe does not remain coiled when connected to the patient, but tends to stretch out to aid drainage. desirable. Discharge piping may be made of polyvinyl chloride (PVC), silicone, latex, Teflon, or other polymer materials.

As shown in Figure 1, the sides 8 and 9 of the tray form two orthogonal inner walls of the main compartment 1 and the sides 8 and 9 form a corner of the main compartment 1 where they intersect each other. do. Two additional, internal partitions 10 and 12 separate the main compartment 1 from the other compartments. The two interior partitions 10 and 12 include reduced height portions 14 and 16 (having a reduced height compared to the full height partitions, interior walls, or sides of the tray).

Additionally, the main compartment 1 includes internal fillets 18 at the corners formed between the bottom of the main compartment 1 and its internal walls. These fillets 18 can reinforce the corners of the main compartment 1.

For example, as shown in Figures 1, 2 and 5, the main compartment of the tray may contain instructions/procedure indicators and/or other information coupled thereto. For example, the main compartment may have a logo or brand name written thereon, for example, "SureStepTM Foley Tray System" and "BARD." The main compartment may further, or alternatively, include instructions/procedural indicators related to catheter insertion printed or otherwise incorporated thereon. Optionally, the main compartment may contain guidelines/procedural indicators for proper poly treatment and maintenance. As shown, for example in Figures 1 and 5, instructions/procedural indicators incorporated in the main compartment include "(1) Secure Foley with StatLock®", "(2) ) position bag below bladder", "secure tubing to sheets with clip", "(3) document insertion date", Guidelines specifying “(4) maintain red seal per hospital policy” and “(5) assess need for catheter routinely.” May contain procedural indicators. Instructions/procedure indicators or other information may be called out in bold or in some other way for greater visibility to ensure that the physician reads the instructions/procedure indicators or other information. Optionally, instructions/procedural indicators may be included in the main compartment to remind the healthcare provider/physician to instruct the patient on how to properly care for and maintain the catheter after catheter insertion. Instructions/procedural indicators can be used to help the health care provider/physician remember to process important instructions that must be given to the patient.

The syringe or catheter compartment 2 has an elongated shape and spans approximately the entire length of the tray. The partitions and internal walls of the tray contribute to forming the syringe or catheter compartment (2). A partition (12) spans between opposing inner walls of the tray and separates the syringe or catheter compartment (2) from the other compartments, namely the main compartment (1) and the swap compartment (3). The syringe or catheter compartment 2 is sized and shaped to contain one or more syringes (e.g. a syringe of lubricating jelly and a syringe of sterile liquid to inflate a retention balloon) and/or a catheter such as a Foley catheter. This is formed. For example, a syringe for lubricating jelly and a syringe for 10 cc sterile water may be packaged in the syringe or catheter compartment 2, but the end user (e.g. a physician) may remove the syringe upon insertion of the catheter. and the catheter may be placed in the syringe or catheter compartment (2) prior to insertion into the patient (to help lubricate the catheter).

Part of the partition 12 separates the catheter compartment 2 from the main compartment 1. A portion of partition 12 has a full height (e.g., extending as high as the sides of the tray), but partition 12 may further include reduced height portions 16 and 22 (partition ( 12), having a reduced height relative to the maximum height of the internal walls, or sides of the tray). The reduced height portion 16 of the partition 12 which allows the syringe or catheter compartment 2 in the partition to be fluidly connected with the main compartment 1 and vice versa can act as a break or aperture. Along the reduced height portions 16, a partition 12 is shown for example in Figures 2 and 6 (see further Figures 31a-31c) between the syringe or catheter compartment 2 and the main compartment 1. Small stairs like those can be formed. A step is also formed by the main compartment (1) having a lower/deeper bottom than the bottom of the syringe or catheter compartment (2) as shown in Figures 2 and 6 (see further Figures 31A-31C). It can be.

1 and 2, another reduced height portion, namely reduced height portion 22, separates the syringe or catheter compartment 2 from the swab compartment 3. The reduced height portion 22 of the partition 12 has a partial or reduced height relative to the maximum height of the sides or interior walls of the tray. Figure 5 shows an alternative arrangement of the reduced height portions 16 where both reduced height portions 16 are located along the partition between the main compartment and the syringe or catheter compartment. Other arrangements and configurations are also possible. If syringes were packaged or contained in a syringe or catheter compartment 2, the reduced height portions (e.g., reduced height portions 16 and 22) provide more open space for the end user to reach the tray and grasp the syringe. Providing space helps facilitate easy removal of the syringe from the syringe or catheter compartment (2). This makes removal of the syringes easier than if the partition 12 did not have reduced height portions and the doctor had to attempt to pick up the syringes in a narrower area.

As shown for example in Figures 1 and 5, the syringe or catheter compartment of the tray may further include instructions/procedure indicators and/or other information incorporated thereon. For example, the syringe or catheter compartment may optionally include instructions/procedure indicators associated with catheter insertion written thereon. As shown in Figures 1 and 5, the instructions/procedure indicators incorporated into the syringe or catheter compartment are "Dispense & Lubricate Foley" (alternatively, these instructions simply read "Lubricate Foley"). ", "Dispense Foley" or something similar), "Retract the genitals (with your non-dominant hand)", "Prepare the patient with swabs (with your dominant hand)", "Insert the catheter. and inflate the balloon (with your dominant hand).” As described in Figures 1 and 5 and above, the instructions/procedural indicators may include instructions/procedural indicators that are given to the health care provider. The step may indicate which hand should be used, for example the dominant hand or the non-dominant hand. Instructions/or procedural indicators or other information may be used by the physician. The letters may be in upper case letters (bold) or displayed in some other way for greater visibility to ensure that other information is readable.

Note that the sides of the catheterization tray may further contain instructions/procedural indicators or other information thereon. For example, as shown in FIGS. 1, 2, and 5, side 6 includes an instruction/procedural indicator 47 that reads “open iodine,” and side 7 includes “open water gun.” “Attach” may include instructions/procedural indicators (49). Instructions/procedural indicators or other information As shown in FIGS. 3 and 4, the bottom 55 of the syringe or catheter compartment 2 may be offset from the bottom of all other compartments. That is, the bottom 55 of the syringe or catheter compartment 2 may not be as deep or as far from the top of the tray as, for example, the bottom 57 of the main compartment. As the floor 55 is offset from the floor of the other compartments, the bottom/floor of the syringe or catheter compartment is offset from the bottom/floor of the other compartments, including being offset from the bottom/floor of the main compartment 1. It can be.

The swap compartment (3) extends along the side (6) of the tray along a portion of the inner wall of the tray forming the side of the swap compartment (3). The swab compartment 3 contains various items, for example swabs or swab sticks and one or more antiseptic agents such as iodine (e.g. iodophores such as povidone-iodine, tincture of iodine, aqueous iodine, etc.). It can be included. Partitions 10 and 12 extend along the two different sides of the swap compartment 3 forming two different sides of the swap compartment 3 and separate the swap compartment 3 from the main compartment 1. Separate from each syringe or catheter compartment (2). For example, in one embodiment as shown in Figures 1 and 2, the partition 12 separating the swap compartment 3 from the syringe or catheter compartment 2 has a reduced height (i.e. , while having a reduced height portion 22), the partition 10 has a maximum height separating the swap compartment 3 from the main compartment 1. For example, in one embodiment shown in Figure 5, both partition 10 and partition 12 are configured to determine whether they separate the swab compartment 3 from the main compartment 1 and the syringe or catheter compartment 2. It has a maximum height regardless of whether

The swab compartment (3) spans between the small storage or overflow compartment (4) and the syringe or catheter compartment (2) and has an inclined bottom/floor with a downwardly angled surface therebetween (i.e., the catheter compartment (2) The lower part/floor of the nearby swap compartment (3) is lower than the surrounding storage compartment (4). As such, fluid poured into the swab compartment can flow in a direction toward the catheter compartment 2 and near the partition 12 separating the swab compartment 3 from the catheter compartment 2 (e.g., Figures 1 and 1 ). It may flow towards a pit or a sump in the lowest/deepest part of the swap compartment (adjacent to the reduced height portion 22 in Figure 2). Fillets similar to the fillets 18 in the main compartment 1 may be included in the corners of the swap compartment 3, for example as shown in Figures 1 and 2.

Figure 8 shows a larger view of the swap compartment 3 and the adjacent storage or overflow compartment 4, with the swaps and swap sticks included in the swap compartment 3. Near the overflow compartment 4, the lower/floor of the swap compartment 3 may be supported by a small storage or another partition 30 separating the overflow compartment 4 from the swap compartment 3 ( shown in Figure 2). Additionally, the partition 30 allows the lower/floor of the swap compartment 3 to remain unobstructed near the small storage or overflow compartment 4 (thereby allowing swabs or swap sticks with longer sticks, for example). For example, it may extend from the lower/floor of the swap compartment 3 to a portion of the small storage or overflow compartment 4 as shown in Figure 8). It can only extend upwards from the bottom/floor of the overflow compartment (4)) to the bottom/floor of the swap compartment (3). This design or arrangement allows a small storage or overflow compartment (4) to act as an overflow pit when too much fluid/iodine is poured into the swap compartment (3).

The swap compartment (3) comprises one or more channels (28) extending at least partially along the area between the pit located at the bottom/floor of the swap compartment (3) and the small storage and overflow compartment (4). On the side of the swap compartment (3) near the catheter compartment (2), channels (28) extend into the pool at the lowest/deepest part of the pit (24) adjacent to the partition (12) and It is fluidly connected to the pool at the lowest/deepest part of the pit 24, so that liquid poured into the channel(s) 28 flows down the slope and into the pool at the lowest/deepest part of the pit 24. It can flow downward through the channel(s) 28 along . Channel(s) 28 can contain extendable devices (e.g., swaps and swapsticks) and each channel 28 can contain extendable devices (e.g., swaps and swapsticks). ) may be separated by one or more barriers 26 that help keep the Channel(s) 28 may have snap-in features 32 (e.g., snap-in tabs) or undercuts that can help secure elongated devices such as swaps, swap sticks, etc. Additional features may be included.

For example, as shown in Figures 1, 5 and 8, the swap compartment of the tray may further include instructions/procedural indicators and/or other information incorporated thereon. For example, the swap compartment (e.g., on one of the barriers 26) may include instructions/procedure indicators associated with catheter insertion, printed or otherwise included thereon. As shown in FIGS. 1, 5 and 8, instructions/procedural indicators incorporated over the swap compartment may include an instruction/procedural indicator that states “Pour iodine here.” Instructions/procedure indicators or other information may be in bold type in the upper case letters for higher visibility to ensure that the physician reads the instructions/procedure indicators or other information, or otherwise. Can be displayed (call out).

One or more swaps or swap sticks (e.g. swap or swap stick 34 shown in FIGS. 6A-8) may be packed in swap compartment 3 and contained within channels 28 (e.g. For example, as shown in Figure 8). Swaps or swapsticks may be specially designed to fit into the swap compartment (3) and be contained in channels (28). Swap compartment 3 may further contain iodine or povidone-iodine solution. The iodine or povidone-iodine solution may be packaged in its own container, packet, or syringe within the swap compartment 3, for example the povidone-iodine packet shown in Figure 26. Alternatively, the iodine or povidone-iodine solution may be placed directly with the swab(s) or swab stick(s) 34, for example packaged/sealed such that it is in contact with the lower/floor portion of the swab compartment 3. It can be stored and/or sealed within the swap compartment (3) while in contact with it. 6-6C illustrate one embodiment of a swap or swapstick with an elongated member or stick/stem having more rounded sides (e.g., in cross section) compared to the swap or swapstick shown in FIGS. 7A-7C. An example is shown. 7A-7C illustrate a swap or swapstick 34 with an elongated member or stick/rod 38 having less rounded or more angled sides compared to the swap or swapstick 34 shown in FIGS. 6A-6C. ) shows an example of. As shown in Figures 6A-7C, swap or swapstick 34 represents other possible swaps or swapsticks that may be included. The swab or swabstick 34 includes an absorbent head 36 and an elongated member or stick/stem 38. The absorbent head 36 is designed to allow greater saturation in the cleaning solution (e.g., iodine or povidone-iodine solution) and to have greater contact with the surface area of the area to be cleaned. The absorbent head 36 may be formed from foam, rayon (e.g., puffs or spirals of rayon), cotton, other materials, and/or a combination of one or more of these materials. In order to increase the saturation of the absorbent head, the absorbent head 36 is preferably made of a material that easily absorbs and distributes the cleaning solution. Any material that absorbs a significant percentage of its weight in cleaning solution, especially if it is capable of expelling a large percentage of the absorbed cleaning solution (i.e., can absorb and also expel large quantities of absorbent solution when used for cleaning patients). (If possible) the use of an absorbent head is preferred. It is known that forming the absorbent head 36 of foam (as opposed to rayon or other materials) provides improved absorption and saturation of the cleaning solution. Furthermore, the foam absorbent head easily releases large amounts of cleaning solution when contacted and gently pressed against the area to be cleaned on the patient. This easy release of cleaning solution makes it easier to clean the patient's area and allows the end user to be more courteous 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. (honey gold) foam, or other types of foam. The absorbent head may be attached to the elongated member or stick by applying heat (e.g., foam may be heated to adhere to the stick), or other means of attachment may be used (e.g., the use of an adhesive). ).

Preferably, the material or foam selected for the absorbent head should not decompose or at least resist decomposition upon contact with the cleaning solution. In one embodiment, the swab or swabsticks are stored in contact with iodine or povidone-iodine solutions so that they are already saturated when first contacted in the catheterization package. For example, a seal may be placed within or on the swab compartment to prevent leaks and to keep the cleaning solution in contact with the absorbent head of the swab stick until the seal is removed. It is important that the absorbent head does not degrade over time when packaged and stored in contact with cleaning solutions. For example, honey gold foam is sufficiently resistant to decomposition when contacted with iodine or povidone-iodine solutions.

Absorbent heads 36 may vary in size and shape. Preferably, the foam is formed in a way that provides more contact with the surface area of the area to be cleaned. For example, the absorbent head 36 may have a distal end or a distal region (e.g., areas in contact with the patient) that are less in contact with the patient (e.g., a proximal end or an area in which the absorbent head 36 may have an elongated member). Alternatively, it may be formed to be substantially larger than the stick 36 and the attachment point). This gives the absorbent head a larger area of contact with the patient and makes cleaning the patient faster and easier. Furthermore, the distal portion of the absorbent head is larger, so the majority of the iodine is absorbed into the area that is in contact with the patient (conversely, if the largest area is not or near the distal portion, much of the iodine is absorbed into the area that is in contact with or near the patient). will be absorbed wastefully into areas that are not cleaned). The absorbent head 36 can be of the same shape as shown in Figures 6A-7B and can be wider than its thickness. The absorbent head 36 may be generally or approximately circular, rectangular or trapezoidal in shape. Optionally, the shape of the absorbent head 36 may be generally or approximately cone-shaped, pyramidal, tear-drop-shaped, or triangular in shape (the large bottom end is similar to the distal tip of the swab or swab stick). It may be (located in), or it may be of another shape. In general, when it is pyramidal in shape, the base of the pyramid shape may generally be a triangle, square, pentagon, hexagon, etc. The edges of the absorbent head may otherwise be curved or tapered at the distal end, generally in a cone-shaped, pyramidal or other shape (e.g., as the distal edges are curved in FIGS. 6A-7B). Furthermore, the distal portion of the elongated member or stick 38 may also be curved (e.g., the distal portion is the upper or furthest edge) as the curves will cause less harm to the patient when cleaning the patient with the swab or swab stick. may be semicircular rather than flat across the surface).

In one embodiment, the length of the absorbent head can be between 0.5 inches and 2 inches (in one embodiment, the length can be approximately 1 inch), and the width of the absorbent head can be between 0.5 inches and 2 inches at its longest ( In one embodiment, the width may be approximately 1 inch at its widest), and the width of the absorbent head may be between 0.1 inch and 1 inch at its narrowest (in one embodiment, the width may be approximately 0.5 inches at its narrowest). ) can be. Furthermore, unless the absorbent head is generally cone-shaped or pyramid-shaped (i.e., if it is the same width and thickness throughout), it may have a thickness that is less than its width, for example between 0.1 inch and 1 inch. (in one embodiment, the thickness may be approximately 3/8 inch).

In one embodiment, the elongated member or stick 38 can have a length between 2 inches and 7 inches (e.g., the elongated member or stick 38 can have a length between 3.5 inches and 4.5 inches, or approximately 4.25 inches. can have a length of). The length at which the stick 38 penetrates into the absorbent head 36 (i.e., the length at which the stick extends distally beyond the proximal end of the absorbent head) is between 0.25 inches and 1 inch (e.g., the length at which the stick 38 penetrates is approximately 0.5 inches). It may be inches). It is desirable to ensure that the penetrating length is within a good range relative to the overall length of the absorbent head. If the stick 38 extends too far into the absorbent head, the patient's skin may be too easily damaged by the stick 38 (e.g., the patient's skin rather than being sufficiently padded by foam during cleaning). can be further rubbed (scrape). On the other hand, if the stick 38 does not extend sufficiently into the absorbent head 36, the absorbent head 36 may be structurally deficient and flutter (especially if saturated with liquid), causing the end user to remove the absorbent head of the swab or swab stick. It makes it difficult to guide and efficiently clean the patient. Ideally, the recessed length of the stick 38 extends between 35% and 70% of the length of the absorbent head 36 (e.g., the recessed length may be about 50% of the length of the absorbent head). . The extension member or stick 38 may be formed from a variety of materials, including plastic or polymeric materials.

The elongated member or stick 38 can have various cross-sectional sizes and shapes. For example, the swab or swabstick may be angled relatively flat or have a generally rectangular cross-section (or similar to a rectangle, but with rounded edges, for example, as in Figure 6C, or cut-off edges as in Figure 7C). It can have a cross section with ), making it easier to hold. The elongated member or stick 38 shown in FIGS. 6A-6C has rounded edges, but otherwise has a generally rectangular shape. This makes the stick easier to hold and manipulate while cleaning a patient compared to sticks with a circular cross-section. Furthermore, this and similar cross-sectional shapes for the extension member or stick 38 allow the swabs or swabsticks to be snapped into the tray or under the features 32 so that the swabs or swapsticks can be stored during transport or use. It can be dipped to prevent it from moving before. To remove the swap or swap stick from this cross section, the extension member or stick 38 can simply be turned clockwise or counterclockwise and the features 32 easily release the swap or swap stick for use. For example, Figure 8 shows two swaps or swap sticks that have been snapped or placed under features 32, and one rotated so that features 32 no longer contain the swap stick or prevent removal. Shows a swap or swapstick. This ensures that the swabs or swab sticks in the swab compartment 3 are very safe during transport and before use, and also makes removal of the swabs or swab sticks during catheterization very simple and easy.

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

The swabs or swab sticks are placed so that the absorbent head 36 is in the lowest/deepest part or pit 24 of the lower part of the swab compartment 3 so that they are in the lowest/deepest part or pit 24 of the lower part of the swab compartment 3. ), and the swabs or swab sticks are loaded and immersed in the tray in such a way that they are easily saturated with iodine or povidone-iodine solution. However, the extension member or stick 38 may be loaded such that the extension member or stick 38 itself is not exposed to iodine or povidone-iodine solution.

The small storage or overflow compartment 4 forms the inner wall of the tray and runs along a portion of the side 6 of the tray forming the side of the small storage or overflow compartment. The other three parts of the small storage or overflow compartment (4) are located at partial height partitions that separate the small storage or overflow compartment (4) from the main compartment (1), swap compartment (3), and corner compartment (5). is formed by These compartments may surround the small storage or overflow compartment 4 on its three sides. A small storage or overflow compartment (4) may act as an overflow pit to collect fluid that may overflow from the swap compartment. Optionally, a small storage or overflow compartment 4 may store or contain one or more items useful for catheterization.

For example, as shown in Figures 1 and 5, a small storage or overflow compartment of the tray may have other information and/or instructions/procedural indicators incorporated thereon. For example, a small storage or overflow compartment may have instructions/procedural indicators related to catheter insertion printed or otherwise included thereon. As shown in FIGS. 1 and 5 , information incorporated into a small storage or overflow compartment may include a reminder that the healthcare provider/physician should "see directions for use for complete instructions." Instructions/procedure indicators or other information may be displayed in bold or otherwise on the top case for greater visibility to ensure that the physician reads the instructions/procedure indicators or other information (call out ).

The corner storage compartment 5 may extend along the sides 6 and 9 of the tray forming the corners and sides of the corner storage compartment 5 . Two other sides of the corner storage compartment 5 separate the corner storage compartment 5 from the main compartment 1 (e.g., the reduced height portion 14) and the smaller storage or overflow compartment 4. It can be formed by height partitions. These parts surround the corner storage compartment 5 on its two sides.

The bottom/floor of corner storage compartments may not be flat; That is, the bottom/floor may be non-planar, round, or partially cylindrical. This shape can be particularly useful for holding specimens or sample containers. Corner storage compartments can store or contain various tools useful for catheterization. For example, a corner storage compartment may contain a label filled by a physician on a first side and affixed to a specimen or sample container on a second side. The second side may already include adhesive thereon; The adhesive may be covered by a removable cover sheet that can be removed upon adhesion. The corner storage compartment may further include a specimen or sample container 54.

In one embodiment, at least some of the compartments may be sealed in a way to prevent contamination thereof. In one embodiment, at least one compartment can be opened independently of at least one other compartment. For example, a user may open the main compartment first, leaving the other compartments sealed. After using the items contained in the main compartment, the user can open another compartment and use the items contained in that compartment.

In one embodiment, the user may open the swab compartment (3) before opening the syringe or catheter compartment (2) or the main compartment (1). The user can pour iodine or another sterile solution into the swab compartment and use the swab compartment to coat the swabs with the sterile solution, and then use the iodine-soaked swabs to clean the user. The user can open the syringe or catheter compartment (2) and dispense lubricant therein before opening the main compartment (1). The user can then open the main compartment 1 to access the catheter. The shape and size of the catheter compartment aid in lubrication of the catheter (e.g., the tip of the catheter can rotate within the elongated shape of the catheter compartment and collect lubricant on its surface during rotation). The catheter can be lubricated with a syringe or within the catheter compartment 2 and then inserted into the patient's bladder.

1, 2 and 5 and mentioned above, according to various embodiments the tray may be lined with step by step instructions/procedural indicators for appropriate or preferred catheterization technique.

Other aspects or features of the catheter insertion package and catheter insertion tray are further described below in the non-limiting context of methods of manufacturing and packaging the catheter insertion package and methods or procedures for using the catheter insertion tray and catheter insertion package. The aspects or features described below are included in the various embodiments already described above. The arrangement of the components and how they are accessed is part of the overall intuitive design of the catheterization package. That is, the components and features are arranged in a logical manner that flows step-to-step to make the catheterization package more intuitive and the procedure easier and/or faster to complete. The stepwise arrangement of components in a catheterization package helps the user/physician logically know the next step. For example, a first item is revealed in a package, and when the first item is used, a second item is revealed below the first item, which is the item that would logically be used next in the catheterization procedure. When a second item is used, a third item is revealed, below the second item, which is the item that will logically be used next in the catheterization procedure.

The catheterization packages and catheterization trays described herein can be used in a variety of ways. Non-limiting methods of use are described below. However, the physician may vary the procedures or steps described herein, rearrange steps, perform additional steps beyond those described, and/or repeat specific steps when the situation and the patient's special needs require. It is possible to remove it. Furthermore, the description below can be thought of as an overall description of many steps, or as a series of individual procedures or individual methods, each of which includes only a subset of the described steps.

First, for example, the catheterization package shown in FIGS. 9 and 10 may be provided (e.g., a health care provider/physician may obtain or select a catheterization package from a shelf or through purchase, or a catheter insertion package may be provided). The insertion package can be placed in the hospital room where the patient is waiting for catheterization.) 9 and 10, the catheterization package may be sealed by an outer container 60 (e.g., a sealable bag) that surrounds the other contents of the catheterization package, ensuring that the contents remain sterile and are properly stored. there is. Inside the sealed bag (or other external container), a paper or cardboard packaging label 62 may be included within the catheterization package. The outer container 60 (or sealed bag) is transparent, or at least partially transparent, so that the practitioner can view the label 62 or portions of the label. Label 62 may include sides 64 that can be folded to extend down the sides of the catheterization package. A label can contain one, two, three, or four aspects. For example, FIGS. 11 and 12 each show a large upper portion 66 and smaller sides or side portions 64 that can be folded into another plane from the plane in which the upper portion 66 is located. The lines in Figure 12 show where folds should be made to form the sides or side portions.

Package label 62 may include instructions and/or other information thereon. For example, label 62 may include initial instructions for catheter insertion. Label 62 includes a logo, trademark or product name printed or otherwise incorporated thereon, such as "SureStepTM Foley Tray System", "Lubri-sil® I.C. Complete Care®", and/or "BARD". can do. Label 62 may further or alternatively include instructions related to catheter insertion written thereon. For example, the label may contain instructions for verifying that the patient meets the CDC guidelines for use of an indwelling urinary catheter, as shown in the lower left quadrant of the upper portion 66 of the labels 62 in FIGS. 9-12. (40) may be included. The label may include a checklist 41 for verifying various elements verifying that the patient is eligible for use of an indwelling urinary catheter under CDC guidelines, for example, the upper portion of labels 62 shown in FIGS. 9-12. As further shown in the lower left quadrant, the label 62 may include a list 42 of components of the catheterization package as shown on the right side of the upper portion 66 of the labels 62 in FIGS. 9-12. ) may further be included. Instructions or other information may be bolded in the upper case letters for greater visibility, or otherwise called out, to ensure that the physician reads the instructions or other information.

Package label 62 may further include key information and variables displayed in a simplified and easy-to-read manner. For example, easy-to-read visual identifiers, squares, other shapes and/or other features, each with one key piece of information or various callouts, may be included. 9-12, the labels 62 are shown as comprising information squares 44 each containing an indicator of one key piece of information about the catheterization package. Information squares 44 essentially isolate and characterize specific information about the catheterization tray from the range of possible variations. The various features and variations include (1) whether the tray contains a drainage bag or a urine meter; 2) French size of the catheter (3) Type of catheter included (4) Substrate type of material (e.g. latex or latex-free) used in the catheter or other components (5) Special components or features, such as inclusion of a StatLock® fastener, inclusion of a special infection control coating, or inclusion of other features. These markings for specific variants, separate from all others, allow healthcare providers to see at a glance what is inside the catheterization package or tray. Therefore, healthcare providers can quickly determine what the key distinguishing elements of a catheterization package or tray are. For example, if the catheterization package in FIG. 9 and the catheterization package in FIG. 10 are both stored on the same shelf, a health care provider can identify major differences between the catheterization packages simply by looking at the information squares 44. Can be distinguished quickly. It is easy to distinguish from the information squares 44 in FIG. 9 that the catheterization package in FIG. 9 includes an 18 French size catheter, drainage bag, and Bard's StatLock®, and that the catheterization package in FIG. 9 is a non-latex catheter. can do. It can be easily distinguished from the information squares 44 that the catheterization package of FIG. 10 includes a 16 French size catheter, drainage bag and Bard's StatLock®.

Furthermore, packaging label 62 can be designed to be visible in multiple planes. The label is designed to be folded at the edge of the catheterization package so that the label (or portion of the label) forms visible sides or side portions when the catheterization package is viewed from the sides, in addition to when viewed from the top. 9-12, the labels 62 are designed such that the information squares 44 are visible on the top of the catheterization package and at least on two sides of the tray. Optionally, the label may be designed so that the information squares 44 appear on all sides (eg, three sides or four sides) of the catheterization package. So, no matter how you stack your catheterization package, you can see the label. Furthermore, multiple catheterization packages can be stacked on top of each other, and the information squares on one or more sides of the catheterization package allow the physician to quickly discern from the stack which catheterization package is desirable for a particular patient.

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

The user can then remove the label 62 and set it aside to reveal the components underneath the label 62. For example, when the label shown in FIGS. 9-11 is removed from the catheterization package, detailed instructions for catheterization or use of the catheterization package or tray document 68 are displayed, for example in FIG. 13 . It can be revealed as shown. Detailed instructions and/or information on safety considerations are therefore one of the first items accessed in the catheterization package. Providing detailed instructions up front allows the user/physician/healthcare provider to review the entire procedure in advance of other steps and before breaking the sterile field created by the CSR wrap around the catheterization tray. This helps the process proceed more efficiently and safely. Pages of detailed instructions can be seen on various pages of document 68 in FIGS. 14A-14D. One or more steps included in FIGS. 14A-14D may be performed as a catheterization method or procedure.

Additionally, there may be additional associated patient education information attached to specific instructions or located separately on the catheterization package. Patient education information can be used by healthcare providers to instruct patients on the use of indwelling catheters, and can ultimately be provided as a reference to patients. Figures 15A and 15B illustrate patient education information that may be included on a patient sheet/pamphlet 70 in a catheterization tray. Figure 15A shows the first side of the patient education information sheet 1 in English, and Figure 15B shows the second side of the patient information sheet 70 in Spanish.

Below detailed instructions/directions for use documentation, the catheter insertion package includes a checklist of safety considerations/steps, a patient information chart, or an insertion sheet containing the safety considerations/steps and patient information associated with the insertion sheet. can do. Figure 16 shows an insert sheet 72 on which patient information, including safety information, can be recorded or charted. Insert sheet 72 can be accessed after detailed instructions are removed from the package. It is desirable to leave the insertion sheet 72 in this position for a final safety check before treating the patient, and to have the patient's important information at hand. Insert sheet 72 may be comprised of a sticker label (e.g., the insert sheet includes a backing that protects the adhesive of the sticker), and once the backing is removed, insert sheet 72 may be associated with a patient-related label. Can be attached to a file or chart.

After removing the detailed instructions 68 and insertion sheet 72 from the catheterization package, a perineal care (or peri-care) packet or kit 74 is revealed, as shown in FIGS. 17 and 18 . Peri-care kits help provide an initial cleanse of the area where catheterization will be performed before further cleaning and disinfecting the area using an iodine solution. This is especially true for patients who are highly contaminated and require initial cleaning before the iodine solution is applied. A peri-care kit may include certain items to aid in the initial cleaning of the patient's perineum or to aid in perineal care in general. For example, as shown in FIGS. 18 and 19, a peri-care kit may include a hand sanitizer 76 (e.g., a germ-free gel hand rinse), a moist towelette 78 for a healthcare provider to disinfect their hands. (e.g., a package of Castile soap towelettes), instructions/procedural indicators 80 (e.g., instructions/procedural indicators for a health care provider and/or instructions for a patient). Hand sanitizers can be designed to have improved efficiency and/or to enable one-handed use.

17-19, the items of the peri-care kit may be included in a bag 82 (e.g., a zip lock baggy) or other packaging to hold the items/components together. . In one embodiment, the type of bag used for venting is a bag that includes a zipper (84). These bag types are known to be easier to open with gloves than bags that have to be opened by, for example, tearing, or bags without zippers. However, bags with holes instead of zippers or zip-lock features are also considered, as they may be cheaper to manufacture.

Peri-care instructions/procedural indicators 80 are shown in FIGS. 17-19. Instructions 80 are provided to the health care provider: “1. Wash hands and donning gloves”, “2. Explain procedure to patient and open peri-care kit”, “3. “Use the packet of towelettes provided to clean the perineal-urethral area,” and “Remove gloves and perform hand hygiene with the provided alcohol hand sanitizer gel.” Other guidelines/procedural indicators are also possible. The method may include performing some or all of the four steps mentioned above as steps in the instructions.

The method proceeds in three main stages: (A) initial peri-care stage, (B) catheter insertion stage, and (C) catheter care and maintenance stage. Each of these steps is marked in the instructions/procedural indicators and/or other materials with a large "A", "B", or "C" to signify the different major steps. As shown in the peri-care instructions 80, there is a large “A” at the top of the instructions/procedural indicators to indicate the first step. As discussed elsewhere herein, the belly band 46 contains a large “B” to indicate the second stage, and the main compartment 1 of the catheterization tray contains a large “C” to indicate the third stage. "Includes.

After use and removal of the peri-care kit, the belly band/indicator wrapper 46 appears as in Figure 20 (see also indicator wrapper 140 in Figure 30B). The belly band 46 can avoid the tray in at least one direction. The belly band 46 can help maintain a sterilization barrier while leaving the CSR wrap intact. The belly band 46 also helps keep the contents within the tray at all times, so items do not move around.

The belly band/indicator may include instructions/procedural indicators and/or other information thereon. For example, as shown in Figure 20 (see further Figure 30B), the belly band may include instructional/procedural indicators that instruct the healthcare provider how to position the tray in relation to the patient. For example, a belly band may say "position toward insertion point" and may have an arrow pointing to the end of the catheterization tray that should be placed closest to the patient's perineum and urinary tract. This ensures that when the CSR Wrap is opened, the tray is properly positioned for the most logical and intuitive use.

Additionally, as shown in FIG. 20 (see indicator wrapper 140 in FIG. 30B), the belly band 46 is "Using appropriate aseptic technique", "(1) Opening CSR Wrap", "(2) May include instructions/procedural indicators for “wearing sterile gloves,” “(3) positioning underpad,” (4) positioning fenestration drape,” and “following tray instructions (5).” These instructions/procedures may be included. The directives/procedural indicators may include a large “B” at the top to signify that these directives/procedural indicators are part of the catheterization phase or step 2. The directives/procedural indicators may be used by the health care provider to perform the CSR lab. Upon opening the CSR wrap, inform them to perform other steps. Providing this information prior to breaking the sterile barrier provides the healthcare provider with a preview of the procedure and determines whether the sterile barrier will be broken by he/she opening the CSR wrap. Ensures that it is ready when broken.Optionally, a label or sticker that provides the same information as the belly-band described herein may be used in place of the belly-band.

Once the tray is placed and the health care provider has read the belly band instructions/procedural indicators, the next step is to open and/or remove the belly band. After removing the belly band, the sterilization wrap (eg, CSR wrap) can be opened. Figure 21 shows the catheterization tray with three corners of the sterile wrap 56 unfolded to represent unfolding the sterile wrap 56. Please note that the sterile barrier of the catheterization tray and its components are unbreakable until the belly band and sterile wrap are opened. This maintains a sterile barrier while peri-care steps are completed and while the tray is properly positioned and positioned for catheterization. By leaving the sterile barrier in place during the initial stages of the method, there is less chance of contamination and resulting in patient infection.

Once the catheterization tray is positioned as directed by the belly band 46, when the sterile wrap 56 (e.g., CSR wrap) is opened, the tray allows for logical and convenient use of the catheterization tray and its components. are placed appropriately. Trays are arranged and placed for use in logical steps as described herein. The initial view of the sterilization wrap 56 after it has been opened is shown in its entirety in Figure 22 (the breakaway line indicates the actual edge of the sterilization wrap 56 extending beyond the breakaway line shown in Figures 22-29). Sterilization Note that the sterile wrap 56 remains below the sterile tray to form a sterile field for catheter insertion. The tray shown in FIG. 22 and other figures are right-handed biased to facilitate use by a right-handed healthcare provider when standing near the lower edge of the catheterization tray with the syringe or catheter compartment positioned furthest from the healthcare provider (i.e., if If the band points to the genitals between the legs, right-handed users should stand closest to the patient's right leg). Alternatively, the tray may be left-handed (e.g., essentially a mirror image of the tray shown in Figures 22-29 by a mirror placed along the side 7 of the tray or the syringe or catheter compartment).

After initially opening the CSR wrap, as indicated in the belly band 46, the healthcare provider puts on the sterile gloves provided on the tray. As shown in Figure 22, after the CSR wrap has been opened, the top item in the tray is a package 58 of sterile gloves (note that the cuff end of the gloves is indicated at package 58). Sterile gloves may be made of any material known to be suitable (e.g., latex, rubber, or latex-free material). This placement of the gloves on top of the tray below the sterilization wrap allows the healthcare provider to intuitively know that he/she should put on the gloves before proceeding further (as is intuitive, and therefore follows the instructions/procedures on the belly band 46). (It is unnecessary to refer back to the indicators) The package of the gloves can be opened by folding the cuff closest to the health care provider and then opening the package like a book, as shown in Figure 23. Opened in this intuitive and logical manner, the left-hand glove is placed on the healthcare provider's left side and the right-hand glove is placed on the healthcare provider's right side for easy donning of the gloves. For example, as shown in Figure 23, a symbol or other indicator may be included in the package 58 to identify left- and right-handed gloves.

As indicated in belly band 46, the healthcare provider should place the underpad under the patient's buttocks. As shown in Figure 24, when the packaging of the glove is removed from the tray, the underpad and glazed drape are revealed. The folded pad/drape 86 shown in FIG. 24 represents: (1) a waterproof underpad and (2) a separate glazed drape. The underpad may have a waterproof side and a liquid absorbent side. If so, the absorbent side is placed from underneath the patient upwards, and the waterproof side (or plastic side) is placed down. After placing the underpad, as indicated in belly band 46, the healthcare provider may place the fenestration drape over the patient with the genitals visible through the opening in the center of the fenestration drape. Although the underpad and velvet drape are not shown as separate pieces in Figure 24, they are both included in the area of the pad and drape and are arranged such that the underpad is on top of the velvet drape (i.e., for subsequent placement). (because the underpad is placed first to expose the fluent drape). The fenestration drape is logically placed and folded so that the drape is preferably opened away from the surgeon for best use.

After placing the fenestration drape, as indicated in the belly band 46, the healthcare provider follows the instructions/procedural indicators and/or steps written on the catheterization tray itself. As shown in FIG. 25 , removal of the underpad and fenestration drape reveals packaging of a sterile solution 52 (e.g., a povidone-iodine solution) (FIG. Note that this shows the fenestrated drape being moved (moving the drape in this way or positioning the fenestration drape over the patient will expose the sterile solution in the swab compartment). Additionally, the first instruction/procedural indicator 47 on the tray (i.e., "Open (1) Iodine"; variations on this or other instructions are possible) is located on the left side of the tray (belly band ( When placed as indicated by 46), it can be seen from the side closest to the patient (this is the area where the catheter will be inserted). The placement of the first instruction (47) on the left is logical because people read English from left to right, and it is intuitive to start the instructions from the left (this is adjusted in countries that do not read from left to right). Instructions/procedural indicators are also located close to the sterile or iodine solution 52 in the tray to make them easier and more intuitive to follow.

Assuming the physician is right-handed and has placed the tray as indicated by the belly band 46, the sterile or iodine solution 52 is automatically positioned closest to the patient (however, as discussed above, the tray is positioned as directed by the belly band 46). The bias (e.g., essentially a mirror image of the tray in the drawing) allows a left-handed user to position the tray by the belly band to automatically direct the sterile or iodine solution closest to the patient (e.g., on the opposite side of the tray). Another arrangement is possible, where a right-handed doctor stands opposite a left-handed doctor on the side closest to the patient's left leg. It is desirable for use of the tray to position the sterile or iodine solution (and swab compartment) closest to the patient. Having the swab compartment and pit of iodine solution closest to the patient prevents swabs saturated with sterile or iodine solution from being dragged or moved across the tray (which, if moved over them, could spill onto other components of the tray). Because it prevents.

Figure 26 shows the catheterization tray after removal of the povidone-iodine solution. Note that removal of the packet of sterile or iodine solution 52 reveals a second instruction/procedure indicator 48 and swabs or swab sticks 34 on the tray. This intuitively leads the healthcare provider to pick up the packet of sterile or iodine solution and then logically follow the second set of instructions. The second instruction (48) on the tray is within the swap compartment (3) and says "(2) Pour iodine here" and points to the lowest/deepest point or pit of the swap compartment (3) (nevertheless, Variations of this or other guidelines are possible). If sterile or iodine solution is poured into the barriers or channels of the swab compartment (3), the tilt ensures that the solution flows into the pit or lowest/deepest point.

When the health care provider pours the sterile or iodine solution into the swab compartment (3) and the absorbent heads of the swabs begin to absorb the sterile or iodine solution, the health care provider then inserts the syringe (88) of the sterile solution into the catheter (92). ) (e.g., Foley catheter) can be attached to the inflation port as indicated by the third instruction/procedural indicator (49). The third guide is logically located for use on the side of the tray (7), not far from the pit where the healthcare provider in the swab compartment has just poured the sterile or iodine solution, and near the syringe of the sterile solution. The third instruction is “(3) Attach water syringe” (nevertheless, variations on this instruction or other instructions/procedural indicators are possible). Figure 27 shows the syringe 88 of sterile solution or sterile water after being attached to the inflation port 92 of the catheter.

When the syringe of sterilizing solution 88 is removed from the syringe or catheter compartment, the fourth instruction/procedure indicator 50 (previously obscured by the syringe of sterilizing solution) is revealed. The fourth instruction 50 may tell the health care provider "(4) Lubricate the catheter" or "Dispense and lubricate the foley here" or something similar (again, this instruction or another Variations on the guidelines/procedural indicators are possible). In fact, lubricating the catheter is the next step performed by the healthcare provider. To do so, the health care provider removes the syringe 89 of lubricating jelly, and this removal removes the 5th, 6th, and 7th instructions/procedural indicators that were previously obscured by the syringe 89 of lubricating jelly. reveal In accordance with the present disclosure, the lubricating jelly may be provided in other suitable containers known to those skilled in the art, including, but not limited to, bellows, ampoules, etc. The healthcare provider can then lubricate the catheter in any desired manner. In one embodiment, a healthcare provider may remove plastic wrap 90 (shown in FIGS. 27 and 28 ) from catheter 92 (which may be a Foley catheter), e.g., a portion of catheter 92 . For example, it can be moved to the syringe or catheter compartment (2) as shown in Figure 28. Placing the distal portion 94 of the Foley catheter 92 into the syringe or catheter compartment 2 assists in positioning the catheter 92 for lubrication and catheterization. For example, as shown in FIG. 28 , at the distal end 94 of the catheter 92 located near the leftmost side of the syringe or catheter compartment 2, the distal end 94 of the catheter 92 is positioned near the leftmost end of the syringe or catheter compartment 2. It is located very close to the area to be inserted (assuming the tray is positioned as indicated by the belly band 46). Additionally, the distal tip of the catheter 92 essentially points to the area where the catheter will be inserted, such that the health care provider simply holds the catheter 92 and moves it in a direction indicating that insertion of the catheter 92 into the patient is to begin. It is positioned to do so. Once the catheter is placed in the syringe or catheter compartment 2, the user dispenses lubricating jelly from the syringe 89 toward the distal portion of the catheter 92 and into the syringe or catheter compartment 2 (e.g., the syringe is placed in the catheter compartment 2). can be dispensed on the left side of the syringe or catheter compartment near the patient and the area to be inserted), and twist the catheter 92 to ensure that the lubricating jelly is properly lubricated.

Although the above method of lubrication is preferred for the reasons stated above, other methods of lubricating the catheter 92 are also possible. In one embodiment, the healthcare provider dispenses lubricating jelly onto the sterile/CSR wrap around the tray and places the end of the catheter in the lubricating jelly to lubricate it. In one embodiment, the user can dispense lubricating jelly with a syringe or directly into the catheter area 2 before moving the catheter 92 from the main compartment 1 and then moving the distal portion of the catheter 92 into the lubricating jelly. You can.

After lubricating the catheter 92, the health care provider allows him to retract the penis with his non-dominant hand and prepare his dominant hand with swabs or swab sticks that the user has saturated with sterile or iodine solution. and during use for disinfection, the catheter 92 may be placed in the syringe or catheter compartment 2. Swabs or swab sticks (e.g., the absorbent head 36 and stick 38 discussed above) The provided swaps or swap sticks 34 can be turned to easily release them from the channels of the swap compartment as mentioned above. Preferably each swab or swab stick will be used to rub the patient only once. For female patients: (1) using downward strokes to clean the right labia minora with one swab or swap stick and discarding the swab or swap stick; (2) cleaning the left labia minora with another swab or swap stick; The patient can be cleaned by using downward strokes to clean and discarding the swab and swab stick, and (3) using the swab or swab stick to clean the intermediate area between the labia minora. For male patients, you can clean the patient with a swab or swab stick using circular movements starting at the urethral opening and working outward. After prepping and disinfecting the patient in this way, the health care provider uses his or her dominant hand to insert a catheter into the patient's bladder (once the catheter enters the bladder, urine will be visible in the tubing, but the retention balloon will remain in place). (an additional 2 inches must be inserted from this point to allow entry into the bladder), and inflate the retention balloon in the bladder by injecting sterile fluid from a syringe of sterile fluid 88 into the catheter 92 through the inflation port. . In fact, these are the instructions on the Step 5, Step 6, and Step 7 trays, respectively: "(5) Retract genitals (non-dominant hand)" and "(6) Prep patient with swab. These are the steps indicating “Do this (with your main hand)” and “(7) Insert the catheter and inflate the balloon (with your main hand).” Variations to these guidelines/procedural indicators or other guidelines/procedural indicators are possible. Once inflated, the healthcare provider can gently pull on the catheter until the inflated balloon fits snugly against the bladder neck. These steps complete Phase "B" or catheterization phase of the procedure.

Figure 29 shows what the tray will look like immediately after the catheter is properly placed in the patient. Note that drain tubing 95 easily follows catheter 92 toward the patient and out of the tray. The folded urine collection bag 96 may be positioned within the main compartment 1 in FIG. 29 and packaged preconnected to the tubing 95, catheter 92, and/or other components of the catheter assembly. The urine collection bag 96 can be unfolded and hung under the patient to collect urine as it is withdrawn from the patient.

After catheterization of the patient (i.e., after the catheter is inserted and the retention balloon is inflated in the patient's bladder), additional steps may be taken. For example, in Phase “C,” or the Care and Maintenance Phase, the health care provider may: (1) secure a Foley catheter to the patient (e.g., using a StatLock® device), (2) place a urine bag and/or Alternatively, position the urine meter below the patient's bladder (for example, at the bottom of the bed, attach the bag to a hanger on the bed rails) and secure the tubing to the bed sheets in a way that does not kink the tubing (for example, (3) record 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 (3) record the date of catheter insertion according to hospital protocol. (4) maintain the catheter (e.g., if the catheter has a red seal, retain the red seal), (5) reassess the need for an indwelling catheter by periodically assessing whether the catheter has become unnecessary ( 6) and/or other management or maintenance steps.

Instructions/procedural indicators associated with step “C” are identified in the main compartment of the catheterization tray as shown in FIGS. 1, 2, and 5. For example, Step "C" instructions/procedural indicators are: "(1) Secure poly with StatLock®," "(2) Place bag under bladder," and "Clip tubing to seat." This may include “(3) recording the date of insertion,” “(4) maintaining the red seal in accordance with hospital policy,” and “(5) periodically assessing the need for the catheter.” Variations on these guidelines/procedural indicators or other guidelines/procedural indicators are possible. As indicated in Figure 14D, a urine sample may be received. Ultimately, the catheter can be removed as indicated in Figure 14C.

The catheterization packages and catheterization trays described herein may be manufactured/packaged in different ways. For example, a manufacturer or distributor of a catheterization package may modify the steps or procedures described herein, rearrange the steps, perform additional steps beyond those described, and/or environmental and Certain steps may be omitted when special requirements are required. Furthermore, any features, components, arrangements, designs, arrangements of components, etc. described above (e.g., features or arrangements that make the catheterization package more intuitive or logical to use) may be used during manufacturing. Can be added to or included in a catheter insertion package (e.g., in a method of manufacturing/packaging). However, non-limiting methods of manufacturing/packaging are described below. The steps described herein may be performed in the order described or out of order.

In one embodiment, the catheterization package is manufactured/packaged by providing a catheterization tray (e.g., a catheterization tray comprising or similar to the features shown in FIGS. 1-5 and those described above). Trays are purchased or formed by the manufacturer of the catheterization package. Once manufactured, the tray may be formed using an injection molding process or other suitable process. Instructions/procedural indicators are incorporated into the tray, printed or otherwise included, as described above or shown, for example, in Figures 1, 2 and 5.

Various components (eg, any of the components discussed above or elsewhere herein) can be added to the tray. In one embodiment, a pre-connected discharge system may be added/included in the tray (e.g., in main compartment 1 shown in FIG. 26). The drainage system may include a drainage/collection bag 96, drainage tubing 95, catheter 92 (e.g., Foley catheter), drainage outlet, urine meter, or other drainage components. Swaps or swapsticks 34 may be added/included in the tray (eg, in the main compartment 3 as shown in Figure 8 or Figure 26). A specimen or sample container 54 and a label that may be filled with details relating to the sample and may be glued to the sample or sample container may be added/included in the tray (e.g., corner storage compartment 5 shown in FIG. 26 ). )to). A packet or container of sterile skin cleanser 52 (e.g., a packet or container of povidone-iodine solution) may be added/included in the tray (e.g., swab sticks 34 as shown in FIG. 25 ) in the swap compartment (3) at the top of the ). A packet or container 89 of lubricant (e.g., a syringe of lubricating jelly) may be added/included in the tray (e.g., in a syringe or catheter compartment as shown in FIG. 26). A syringe 88 of sterile liquid (e.g., a 10 cc syringe of sterile liquid to inflate the retention balloon of a Foley catheter) is placed in the tray (e.g., a syringe of lubricating jelly 89 as shown in FIG. 26 ). The syringe and catheter compartment (2) may be added/included on top or partially on top of the syringe and catheter compartment (2). A fenestration drape for placement over the patient may be added to/included in the tray (eg, on top of other components) and may expand into portions of one or more compartments as shown in FIG. 24 . An underpad (e.g., a waterproof absorbent underpad) placed under the patient's buttocks may be added to/included in the tray (e.g., on top of a fenestration drape or other component) and may extend into portions of one or more compartments. there is. Both the underpad and the glazed drape are represented as pad/drapes 86 in the drawing. Gloves (e.g., package 58 of rubber gloves, latex gloves, latex-free gloves) may be added/included in a tray (e.g., on top of an underpad or other component), as shown in FIG. 22 As shown, it can be expanded into parts of one or more compartments.

The tray and components can be sterilized and a sterile wrap 56 (e.g., CSR wrap) can be folded or wrapped around the catheterization tray as shown in FIGS. 20 and 21. A belly band 46 (e.g., to help hold the sanitizing wrap in a folded configuration and retain all contents within the tray, preventing items from moving around) may be included around the sanitizing wrap 56 as shown in FIG. 20 . You can. A perineal care (or peri-care) packet or kit 74 (e.g., as shown in FIGS. 17-19) may be added to/included in the catheterization package (e.g., FIGS. 17 and 18 may be placed on a belly band 46 and/or a sterilization wrap 56 as shown in). The perineal care packet or kit 74 includes hand sanitizer 76 (e.g., a germicidal gel hand rinse), a moist towelette 78 (e.g., a package of castile soap towelettes), and instructions 80. (instructions for healthcare providers and/or instructions for patients), and/or other components (see, for example, Figure 19). An insertion sheet or label 72 with instructions or other information may be added/included in the catheter insertion package (e.g., an insertion sheet or label with a checklist of safety considerations/steps and/or patient information A chart may be at the top of a perineal care packet or kit, as shown in Figure 16. Detailed instruction documentation (e.g., as shown in Figures 14A-14D) and/or patient education information (e.g., Figure 15A) and as shown in FIG. 15B ) may be added/included in the catheterization package (such as an instruction for use document 68 ) and/or a patient education pamphlet 70 as shown in FIG. 13 A packaging label 62 (e.g., the packaging label shown in FIGS. 9-12 and described above) may be added to/included in the catheter insertion package (e.g. (e.g., with the edges folded over all other components and to cover the sides of the catheterization tray). The catheterization package can be sterilized and sealed (e.g., in a sealed container or as shown in Figures 9 and 10). in bag 60).Other components useful for catheter insertion or care may also be included.

In one embodiment, the catheterization system includes a ureteral catheter assembly and/or materials or supplies (e.g., catheterization elements or components such as disinfectant liquid, lubricant, inflation fluid, gloves, etc.) appropriate or essential for the ureteral catheterization procedure. may include. For example, the catheterization system may have multiple compartments for storage and securing of ureteral catheter assemblies (e.g., assemblies comprising Foley catheters) and other sterile and/or non-sterile catheterization systems, including those mentioned above. It may include a catheterization tray having elements. Sterile catheterization elements may be stored in a manner such that the sterile elements remain uncontaminated by non-sterile catheterization elements.

The catheterization tray may include one or more visual, procedural indicators or instructions to assist users during the catheterization procedure. For example, procedural indicators assist the user by positioning the catheterization tray (and its catheterization components or elements) in relation to the patient so that the catheterization components and/or elements are predictable and appropriate or desirable for the patient and patient. /or may be located in a placement or location relative to the user. Additionally or alternatively, procedural indicators can assist the user in the use of catheterization components in sequencing and/or their removal from the catheterization tray.

As mentioned above, catheterization trays and systems including such trays can aid aseptic techniques during catheterization procedures. In one embodiment, such as that shown in FIG. 30A, catheterization system 100 may include a catheterization tray and a container 110 (e.g., a sealing bag) that can seal the catheterization components. For example, container 110 can help maintain the sterility of sterile catheterization components. For example, container 110 may be a plastic bag (eg, polyethylene bag). Additionally, container 110 includes a peelable side 111 separated from a non-peelable side 112 to form an opening in container 110 (container 60 above has similar features and attributes). can do; Contents located within the container 110 may be removed through the opening.

In one embodiment, a portion of the catheterization tray and its contents (i.e., catheterization components) are at least partially surrounded or wrapped by identification cover 120. In one embodiment, a packaging label or identification cover 120 (e.g., similar to packaging label 62 discussed above) may provide indicia related to the contents and/or type of catheter system 100. , may include one or more visual identifiers containing key information and variables, such as visual identifiers 121, 122, and 123 (e.g., they may be similar to the information squares discussed above).

For example, the packaging label or identification cover 120 may be manufactured from a sheet-like material such as paper, cardboard, plastic (eg, plastic film), etc. Visual identifiers 121, 122, and 123 may be configured to convey sufficient information for a user to identify the specific type of catheterization system 100 and/or its contents. For example, visual identifier 121 may identify the size of the catheter (eg, 16 French, etc.). In one example, visual identifier 122 may indicate that catheterization system 100 includes a urine meter (which may be attached to a catheter) and/or visual identifier 123 may indicate that catheterization system 100 includes a catheter stabilization device ( For example, it can be indicated that it includes STATLOCK).

Visual identifiers 121, 122, and 123 may be visually separate or isolated from each other. For example, visual identifiers 121, 122, 123 may include a square or rectangular outline, generally defining its outer boundary or determining its extent. That is, the identification information of the visual identifiers 121, 122, and 123 may generally be included within the rectangular outline of the visual identifiers 121, 122, and 123. Therefore, for example, a user can easily and/or quickly place appropriate information on identification cover 120 to identify and/or select a particular catheterization system 100 appropriate for a procedure.

One, some, or all of the visual identifiers may include visual indications or information that may inform the user about specifics of the catheterization system 100. For example, visual identifiers 121, 122, and 123 may include text, images, symbols, etc. Additionally, the visual identifiers 121, 122, 123 and/or portions thereof may have an appropriate color or multiple colors that may assist the user in identifying and/or distinguishing the visual identifiers 121, 122, 123. there is. In one embodiment, at least one of the visual identifiers 121, 122, and 123 may have a different color than the others.

The shape, size, thickness, or combination thereof of a specific outline surrounding or including the identification information of the visual identifiers 121, 122, and 123 may vary depending on the embodiment. As such, visual identifiers 121, 122, and 123 typically have a circular, triangular, or polygonal shape. Furthermore, the identification cover 120 capable of carrying visual identifiers 121, 122, 123, including any number of suitable materials, may vary from embodiment to embodiment. For example, visual identifiers 121 , 122 , 123 may be printed, embossed or otherwise transferred to identification cover 120 .

Identification cover 120 may also include any number of visual identifiers. That is, visual identifiers 121 , 122 , 123 may be placed and/or duplicated in any number of suitable locations on identification cover 120 . For example, identification cover 120 may include visual identifiers 121, 122, 123 on its major or non-primary side. In one embodiment, visual identifiers 121, 122, and 123 may be located on one, some, or all of the visible sides of catheterization system 100 (e.g., visual identifiers One, part or all of (121, 122, 123) may be visible on any side of the catheterization system 100 during its storage).

Identification cover 120 may be removable from the catheterization tray. For example, the identification cover 120 may be generally separate from the catheterization tray (e.g., the identification cover 120 may be placed on the catheterization tray and be positioned relative to the catheterization tray by the container 110 can be fixed). Furthermore, as shown in FIG. 30B, removing the identification cover may expose a catheterization tray that can be wrapped with or by central supply room (CSR) sterilization wrap. Accordingly, CSR sterilization wrap 130 secures the components to the catheterization tray, at least temporarily.

CSR sterile wrap 130 can be unwrapped and removed from the catheterization tray and used during the catheterization procedure. For example, a CSR sterile wrap is positioned near and/or beneath a patient to provide, at least in part, a sterile environment near the point of the catheterization procedure, thereby reducing the risk of infection associated with the catheterization procedure. CSR sterilization wrap 130 may be substantially opaque, so that the contents of the catheterization tray and/or the location of the catheterization components may be obscured and not visible to the user. Optionally, the CSR sterile wrap is translucent or transparent to allow the user to view and/or visually identify the catheterization components included in the catheterization tray.

Catheterization system 100 may include a belly band or orientation indicator wrapper 140 that may provide an indication of the relative position and/or placement of components in the catheterization tray, which may be invisible to the user. For example, the belly band or indicator wrapper 140 may have directional arrows (direction arrows) that can be aligned by the user to point toward the catheter insertion point, which can position a catheterization tray or catheterization component therein with respect to the patient. 141) may be included. For example, positioning the catheterization tray in a manner that aligns the directional arrow 141 in the direction of the insertion point positions the catheterization components and/or elements at least partially sequentially, allowing for catheter insertion to be used prior to the procedure. The elements and/or components are positioned closer to the patient compared to catheterization components intended for use later in the procedure.

Additionally, the belly band or indicator wrapper 140 may include a warning indicator 142 to inform the user of proper aseptic technique for the catheterization procedure. For example, warning indicator 142 may include one or more specific elements that identify specific steps that are appropriate or essential for proper sterile procedures. In one embodiment, warning indicator 142 identifies one or more of the following steps: (1) opening CSR disinfection wrap 130; (2) wearing sterile gloves; (3) positioning the underpad; (4) positioning the fenestration drape; or (5) following the steps identified by procedure indicators located within the catheterization tray.

Although the indicator wrapper 140 may wrap around the CSR sterilization wrap 130, the present disclosure is not limited thereto. For example, a sticker or adhesive label may be attached to the CSR disinfection wrap and may include the same or similar indicators as the indicator wrapper 140. Alternatively or additionally, the indicators may be placed directly on (eg, printed, embossed or otherwise transferred to) the CSR disinfection wrap.

After the CSR sterilization wrap 130 is removed or unwrapped from the catheterization tray, the contents of the catheterization tray may be exposed. Figure 31A shows the catheterization tray 200 of the catheterization system. Catheterization tray 200 may include multiple compartments that can store or secure various catheterization components. The shape and size of the catheter insertion tray 200 may be defined by its sides. For example, sides 201 , 202 , 203 and 204 may define a substantially rectangular outer shell or outer boundary of catheterization tray 200 .

Catheter insertion tray 200 may be molded (eg, injection molded, thermoformed) or painted (eg, from a plastic material). Therefore, the sides 201, 202, 203 and 204 may be formed from a sheet-like material. One or more sides 201, 202, 203, or 204 may include stiffening ribs 205 that provide rigidity and/or stiffness to the sides 201, 202, 203, 204. The stiffening lips 205 may have a substantially tapered shape and/or may protrude outwardly from individual sides 201 , 202 , 203 or 204 . More specifically, for example, the lower portions of the stiffening lips 205 (portions closer to the bottom/floor of the catheterization tray 200) may be connected to the upper portions of the stiffening lips 205 (portions closer to the bottom/floor of the catheterization tray 200 ) may protrude more from each of the sides 201, 202, 203 or 204 than the portion closer to the opening of ). At least one, some or all of the stiffening ribs 205 may have a partially conical shape.

Catheterization tray 200 may include a swab compartment 210 containing one or more swabs 150 therein. Additionally or alternatively, compartment 210 may include a cleaning/disinfecting solution or disinfecting packet 160 containing one or more disinfecting elements or cleaning/disinfecting solutions (e.g., comprising a povidone-iodine solution). there is. Compartment 210 may be located adjacent to catheterization tray 200 or may be at least partially defined by a side 201 of catheterization tray 200 . In some embodiments, the exterior of disinfection packet 160 may be non-sterile. Therefore, the cleaning/disinfecting solution or disinfectant packet 160 may include a sterile exterior that prevents or reduces contamination of other catheterization components from the non-sterile packet 160 of the cleaning solution or disinfectant in the catheterization tray 200. It can be placed inside another package or bag. The plastic bag may include a zipper or similar mechanism that can be actuated by a user opening or accessing the packet 160 and/or other components therein.

Catheterization instructions may include descriptions and images of the various steps or actions that may be performed during the catheterization procedure. In some embodiments, the instructions may also identify a specific number of steps or actions, thereby suggesting a specific sequence of steps or actions for a catheterization procedure. Catheterization instructions, which may be non-sterile, may be placed within a sterile container, such as a plastic bag, thereby isolating or separating the non-sterile instructions from the sterile catheterization components within the catheterization tray. Accordingly, in some examples, a catheterization system may include multiple sets of catheterization instructions that may improve compliance with sterile catheterization procedures. For example, catheterization instructions may be placed inside a sterile plastic bag and/or on another catheterization element or component (e.g., in a sterile container with disinfection packet 160), or on an external sleeve or catheterization system. It may be attached to a portion, back, or glued (e.g., as a sticker).

Compartment 210 may be configured to contain a disinfectant substance (e.g., liquid) that can be dispensed into compartment 210 from disinfection packet 160. For example, as described in more detail below, compartment 210 may have an angled bottom/floor, allowing cleaning or germicidal solutions (e.g., povidone-iodine solution) or disinfectants from packets 160 It may pool at and/or near the lowest corner between the side of compartment 210 (e.g., partition 211) and the lower/floor. Furthermore, the tips of the swabs 150 may be positioned at or near the lowest corner between the side of compartment 210 and the bottom/floor, such that the tips of the swabs 150 are within the dispensed disinfectant liquid. .

Compartment 210 may be defined, at least in part, by a portion of side 201 or its interior wall, by partition 212, and by a sloped lower/floor. For example, the lowest portion of partition 210 may be located between partition 211 and the angled floor/floor and at a corner edge formed by the partition 211 and the angled floor/floor. Therefore, positioning the tips/absorbent heads of the swabs 150 near the inclined bottom/floor or near the partition 211 of the compartment 210 will cause the tips/absorptive heads of the swabs 150 to be positioned near the partition 211 of the compartment 210. It can be placed at or near the lowest point.

As described above, the catheterization tray 200 may be positioned relative to the patient in such a way that the side 201 and compartment 210 of the catheterization tray 200 are closer to the insertion point than the side 203. That is, positioning the catheterization tray 200 based on the direction arrow of the direction indicator wrapper (while the compartments and contents of the catheterization tray 200 are hidden by the CSR sterilization wrap 130 (FIG. 30B)) Sides 201 and compartments 210 can be placed near the insertion point. In some examples, the insertion point may first be sterilized with swabs 150, which may be saturated with a disinfectant solution from a disinfection packet 160. As such, positioning compartment 210 with swabs 150 and disinfection packet 160 near the point of insertion can reduce the leakage of disinfectant solution (e.g., in one or more of the catheter insertion trays 200 ). Contamination of the swabs 150 may be reduced, which may lead to contamination of the catheter insertion component (over the catheter insertion component) and/or the insertion point.

As described in more detail below, compartment 210 may have a sloped bottom/floor. For example, an upper edge (or surface), such as the upper edge of the catheterization tray 200, may lie in an imaginary plane approximately parallel to a support plane capable of supporting the catheterization tray 200. The angled bottom/floor of compartment 210 may have a non-parallel arrangement with respect to the support plane and/or the imaginary plane of upper edge 206 .

Furthermore, the bottom/floor of compartment 210 may be non-parallel to the bottoms/floors of one or more other compartments in catheterization tray 200 . For example, the catheterization tray 200 may lie on a support plane such that the lower portions/floors of one or more compartments support and/or position the catheterization tray 200 on the support plane. Therefore, as discussed above, the bottom/floor of compartment 210 may have a non-parallel arrangement with respect to the support plane.

Catheterization tray 200 may have a side compartment 220 . For example, section 220 may extend substantially along the entire side or length of catheterization tray 200 (e.g., section 220 may extend between sides 201 and 203 and/or or may be partially defined thereby). Therefore, in some examples, one side of partition 220 may be defined by a side, such as by side 204 .

Compartment 220 may also include any number of suitable elements of a catheterization kit. For example, compartment 220 may include a syringe 170 with a liquid used to inflate a balloon of a catheter (described below) and/or a syringe 180 that may contain a lubricant. As such, the width of compartment 220 may be sufficient to accommodate syringes 170 and 180. In some examples, the syringes 170, 180 may be arranged in a column along compartment 220, placed in a row, one in front of the others therein.

Catheter insertion tray 200 is partitioned 221 with one or more cutouts or recesses that may separate compartment 220 from adjacent compartments (e.g., from catheter compartment 230). can be included in For example, one or more niches in partition 221 may have their top edge located below the upper edge 206 of catheterization tray 200. More specifically, in some examples, niches provide access from compartment 230 to one or more syringes 170, 180. Therefore, a user of the catheterization kit may remove syringe 170 and/or syringe 180 by reaching compartment 230 instead of or in addition to reaching compartment 220. .

In one embodiment, syringes 170 and 180 may be different sizes. Therefore, in one embodiment, at least a portion of compartment 220 may be narrower than another portion thereof to accommodate different sized syringes 170, 180. For example, section 210 may include a narrowing protrusion 222 that extends into the space of section 220, thereby narrowing a portion of section 220. For example, syringe 170 may have a smaller diameter or peripheral size than syringe 180. Accordingly, the narrowing protrusion 222 that narrows the width of compartment 220 is wide enough to accommodate a syringe 180 (e.g., the narrowing protrusion 222 can accommodate a syringe 170 within compartment 220). can prevent or limit horizontal movement).

As mentioned above, catheterization tray 200 may include a main or catheter compartment 230. Section 230 may have a substantially rectangular shape. For example, compartment 230 and its shape may be defined at least in part by at least side 203, at least a portion of side 202, and partitions 212 and 221. While in one embodiment compartment 230 has a generally rectangular shape, it should be understood that the shape of compartment 230 varies depending on the embodiment.

Compartment 230 may be sized (e.g., perimeter dimension and depth), shaped, or otherwise configured to hold or contain 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 examples, compartment 230 may house or include a STATLOCK 193 that secures at least a portion of catheterization assembly 190 during a catheterization procedure.

Compartment 230 has a substantially flat or planar bottom/floor as described in more detail below. For example, the bottom/floor of compartment 230 may support catheterization tray 200 on a support plane. Therefore, in one embodiment, the bottom/floor of compartment 210 has a non-parallel arrangement with respect to the bottom/floor of compartment 230.

As described above, compartment 230 has a substantially rectangular shape. Compartment 230 also has rounded or chamfered interior corners 3231 between interior walls defining the boundary of compartment 230 . Additionally or alternatively, the upper portions of the interior walls and/or partitions may have one or more chamfers or fillets 232 that may extend at least partially along their respective lengths.

Catheterization tray 200 may further include an auxiliary compartment that may contain or contain an auxiliary container (eg, a specimen or sample container). For example, the auxiliary container 195 may be approximately cylindrical and may include a cap. Additionally, compartment 240 may be shaped, sized, and configured to secure auxiliary container 195 therein. In one embodiment, the length of compartment 240 may be similar to the length of auxiliary container 195 (e.g., compartment 240 may have a small gap or interference with auxiliary container 195). In one embodiment, the bottom/floor of compartment 240 may be semi-cylindrical or generally arcuate and may closely follow the general cylindrical shape of auxiliary container 195. Therefore, , for example, the bottom/floor of compartment 9240 may at least partially surround auxiliary container 195 .

For example, as shown in Figure 31B, compartment 240 may have a partially rounded bottom/floor 241. Compartment 240 may be separated from compartment 210 in catheterization tray 200 . For example, catheterization tray 200 may include an overflow cavity 250 located between compartments 240 and 210 . In one embodiment, overflow cavity 250 may form a niche or depression between compartments 210 and 240 . For example, overflow cavity 250 may prevent or limit overflow of disinfectant solution dispensed into compartment 210 . Additionally, the user may tap the disinfectant solution that overflows from the tips of the swabs 150 into the overflow cavity 250 before applying the disinfectant solution at or near the insertion point.

The angled lower/floor 213 of compartment 210 may be raised or stepped above the overflow cavity 250 . For example, the angled bottom/floor 213 terminates in a fillet or radius 214 toward the overflow cavity 250 or its edge from the angled bottom/floor 213 below. Radius 214 may provide a transition between the angled bottom/floor and at least a portion of the overflow cavity 250 located below the angled bottom/floor 213 . The tilted bottom/floor 213 can be tilted downward and away from the overflow cavity 250 .

As mentioned above, the disinfectant solution may be dispensed at the lowest portion 215 of the compartment 210 (e.g., at or near the lowest portion of the sloped lower/floor 213). Additionally, the disinfectant solution dispensed into compartment 210 generally flows toward and pools in the lowest portion 215 of compartment 210. Additionally, the tips 151 of the swabs 150 are fixed or placed in the disinfectant solution. As such, the user can remove the swabs 150 from compartment 210 and apply a disinfectant solution to the insertion point without further action.

The swabs may be secured to compartment 210 by positioning the tips or absorbent heads 151 into a disinfectant solution dispensed into compartment 210 . For example, one, a portion, or each of the swabs may include an extended stem/stick 152 and a tip/absorbent head 151 attached to the stem/stick 152. Additionally, the compartment 210 may include channels 216 that can secure and store the extended stems/sticks 152 of the swaps 150 . Therefore, the stems/sticks 152 of the swaps 150 may be secured to the channels 216 of the compartment 210 .

Channels 216 may include one or more residual features (e.g., detents, overhangs) that may secure the stems/sticks 152 therein. For example, stems 152 have a cross-sectional shape that is approximately rectangular or generally rectangular. When the stem/sticks 152 are placed along the long side of its rectangular cross-sectional shape, the remaining features may secure the extended stem 152 within the channel. Additionally, the swabs 150 within the channels 216 may be rotated or twisted (e.g., so that the short sides of the rectangular cross-sectional shape of the stems 152 lie within the channels 216 ). ) may separate the stems 152 from the channels 216.

That is, the space between the residual features of the channels 216 may be less than the width of the long side of the rectangular cross-sectional shape of the extended stem 152, so that the residual features may be used to form the extended stem/stick 152 into the channels ( 216) It can be suppressed within. Additionally, the space between the remaining features may be greater than the length of the short side of the rectangular cross-sectional shape of the elongated stem/stick 152. Accordingly, rotating or twisting the swabs 150 within the channels 216 causes the extended stem/stick 152 to pass between the remaining features to remove the extended stem/stick 1520 from it. do.

Catheterization tray 200 (and the catheterization trays shown in FIGS. 1-5) can be manufactured in a number of suitable ways with a number of manufacturing techniques. The catheterization tray(s) mentioned above may be injection molded, thermoformed, or otherwise mass produced. For example, catheterization tray(s) can be manufactured from a sheet of plastic material that can be processed by compressing and heating the sheet into an appropriate configuration as described herein. Likewise, one or more sides of one or more catheterization tray(s) may include relatively thin plastic material (e.g., 0.005 inch, 0.010 inch, 0.020 inch, 0.050 inch, 0.100 inch, etc.). As described above, the catheterization tray(s) may include stiffening ribs on one or more sides thereof that may provide rigidity to those sides.

The catheterization tray(s) may include stiffening ribs as described herein in one or more partitions dividing the interior space of the catheterization tray(s) into compartments described herein. Additionally, as described in more detail below, partitions (eg, partition 221) may include folded or dual layers of sheet material. The stiffening ribs may protrude from the section roll (e.g., from section 210, section 220, section 230) and into the space between the layers of sheet material.

As described above, within the compartment, interior corners and/or edges formed by the bottom/floor and interior walls, sides and/or partitions may include fillets or chamfers. For example, such fillets or chamfers can reduce stress at the interior corners or edges of the section. Accordingly, fillets and/or chamfers of the sections formed at the interior corners and/or edges may prevent or reduce breakage or failure of the sheet material forming the catheterization tray 200.

The bottom/floor of compartment 230 may be substantially flat. Additionally or alternatively, the lower/floor of compartment 230 may have a raised landing 232 and a niche portion 233. For example, niche portion 233 may be farther from top edge 206 of catheterization tray 200 than landing 232 . Furthermore, niche portion 233 may at least partially or completely surround landing 232 . As such, for example, niche portion 233 may receive at least a portion of a catheter that may surround landing 232 .

As described above, catheterization tray 200 may be placed on a support plane, such as the surface of the patient's bed. For example, while landing 232 shown in FIG. 31C forms a niche external to catheterization tray 200, niche portion 233 of compartment 230 is external to catheterization tray 200. Forms a protrusion. As such, the exterior surface of niche portion 233 may provide or form a surface capable of positioning or supporting catheterization tray 200 on a support plane. Additionally, in one embodiment, the outer surface of niche portion 233 may be substantially parallel to an imaginary plane of upper edge 206.

Also as mentioned above, the channels 216 of compartment 210 may be generally parallel to the inclined bottom/floor 213 and may be inclined or non-parallel with respect to the support plane. The channels 216 of compartment 210 may have a non-parallel arrangement with respect to the outer surface of niche portion 233 . For example, outside of the catheterization tray 200, the channels 216 may protrude from the angled bottom/floor 213.

A compartment of the catheterization tray (e.g., compartment 210) or portion thereof may carry a disinfectant or cleaning solution (e.g., povidone-iodine solution) therein. For example, at least a portion of the compartment may carry a disinfectant solution and may be sealed by a removable cover. As such, during the catheterization procedure, the user can avoid spilling the disinfectant solution out of the packet (e.g., into the catheterization tray), which can prevent or reduce leakage of the disinfectant solution. The swabs are at least partially submerged in the disinfectant solution and/or partially sealed therewith by a removable cover. Alternatively or additionally, the swabs may be located in another compartment of the catheterization tray.

As described above, portions of catheterization tray 200 may be formed by two layers of sheet material. At least some of the partitions may have spaces between the layers of sheet material. For example, the partition 221 may include a first layer 221a and a second layer 221b spaced apart from each other (e.g., the first layer 221a defines the boundary of the partition 230 The second layer 221b may define or form a boundary of the partition 220.

The stiffening ribs 205 in the first layer 221a of the partition 221 may protrude outwards, away from the compartment 230 and into the space between the first layer 221a and the second layer 221b. there is. The stiffening lips 205 on the second layer may protrude outwardly, away from the compartment 220 and toward the outer border or perimeter of the catheterization tray 200 . In any case, as described above, the sections of the catheterization tray 200 may have indents corresponding to the protrusions formed on the outer part of the catheterization tray 200 by the stiffening lips 205 .

Catheterization tray 200 may include one or more instructions or procedural indicators to assist the user during the catheterization procedure. For example, the catheter insertion tray 200 may include indicators 301 to 307 that can be printed on the catheter insertion tray 200. For example, a first indicator 301 may instruct the user to open a package containing a disinfectant solution and a second indicator 302 may direct the user to pour the disinfectant solution into compartment 210 during a catheterization procedure. You can instruct.

The third indicator 303 may indicate attaching a syringe containing liquid to inflate the catheter balloon to the catheter. In one embodiment, fourth indicator 304 may instruct the user to dispense lubricant or identify or suggest a location in compartment 220 for dispensing lubricant. Additionally, indicators 305-307 indicate additional or alternative steps that must be taken during the catheterization procedure (e.g., retracting the genitals (with a non-dominant hand), preparing the patient with a swab (with the non-dominant hand), (with your primary hand), inserting the catheter and inflating the balloon (with your primary hand).

Catheterization tray 200 may include enlarged or boldly highlighted print of indicators 301 - 307 for improved visibility. Furthermore, other enlarged instructions/indicators may be printed on the bottom/floor of compartment 230, as shown in FIG. 32. The presence of indicators 301-307 on catheterization tray 200 may eliminate or reduce the need for printed handouts or similar instructions.

In one embodiment, as shown in FIG. 33, catheterization system 100a may include one or more procedural indicators 260a in CSR sterilization wrap 130a. Except as otherwise described herein, catheterization system 100a and its elements and components may be similar or identical to catheterization system 100 and its respective elements and components in FIGS. 30A-32. For example, catheterization system 100a may include catheterization tray 200 and the catheterization elements and/or components described above in connection with catheterization tray 200 .

In some embodiments, CSR sterilization wrap 130a may include one or more procedural indicators to assist the user during the catheterization procedure. For example, one or more procedural indicators 260a may each be isolated and/or bordered, or otherwise surrounded by a border outline. In particular, isolating each procedural indicator 260a can draw or focus the user's attention to it and aid its identification. Procedural indicators 260a may include similar or identical information to indicators 301 to 307 of FIG. 32 .

In one embodiment, the catheterization tray may include a fenestrated drape that partially covers the patient and aids insertion of the catheter. 34 shows a fenestrated drape 270. The glazed drape 270 may have a generally rectangular shape. Additionally, glazed drape 270 may include holes 271 . In particular, the holes 271 may generally take the shape of a cutout formed in the fluent drape 270 by tearing a portion of the fluent drape 270 bounded by the holes 271 . In one embodiment, the central portion of the fenestration drape 270 has already been opened (i.e., the inner central material surrounded by the holes 271 is removed prior to wrapping the fenestration drape 270).

The shape defined by the holes 271 or the shape of the central opening may be suitable for accessing the patient's genitals to perform a catheterization procedure after covering the patient with the fenestrated drape 270 . Additionally, in some examples, fluent drape 270 may include side cutouts 272. For example, side cutouts 272 may be generally V-shaped. In one embodiment, side cutouts 272 may help position the fenestration drape 270 near the patient's legs.

As mentioned above, a catheterization system may include various components that assist in the catheterization procedure, such as swabs that help disinfect the area at or near the point of catheterization. For example, swabs 150 may include an elongated member or stem/stick 152 and a tip/absorbent head 151 attached thereto.

The tip/absorbent head 151 has a generally rounded outer or distal portion and a proximal portion that is tapered (e.g., tapering toward the proximal end of the tip/absorbent head 151 and holding an extension stem/stick 152). (tapering towards). For example, the tip/absorbent head 151 may be narrower at the proximal end than at the distal portion (i.e., the distal end may be generally flared and its leading edge may be generally rounded).

Tip/absorbent head 151 may include any suitable material, which may vary from embodiment to embodiment. The tip/absorbent head 151 may be comprised of a liquid or include a liquid absorbing material, absorbing the disinfectant solution and consequently dispensing the disinfectant solution over and/or near the point of catheter insertion. For example, the tip/absorbent head 151 may be comprised of suitable foam, sponge, cotton, etc.

Tip/absorbent head 151 may be attached to elongated stem/stick 152 by any number of suitable mechanisms that may vary from embodiment to embodiment. For example, the tip/absorbent head 151 may be adhesively attached to the extended stem/stick 152 and ultrasonically welded to the stem/stick. The extended stem 152 is positioned so as to leave a sufficient portion of the tip/absorbent head 151 beyond the extended stem/stick 152 (e.g., during application of a disinfectant solution at the insertion point). ) to a predetermined depth that will help to properly secure the tip/absorbent head 151 and the extended stem/stick 152 together in a way that avoids contacting the patient, injuring or injuring the patient. It can enter the absorbent head (151). For example, after being secured to the extended stem/stick 152, the tip/absorbent head 151 has sufficient flexibility and sufficient elasticity and/or hardness such that the tip does not substantially bend after absorption of the disinfectant liquid. It can be kept in place and can be elastically bent while applying a disinfectant solution to the insertion point.

As described above, in some examples, the catheter assembly within the catheterization tray may be positioned generally parallel to a support plane supporting the catheterization tray. The catheter assembly within the catheterization tray may be positioned generally perpendicular or perpendicular to the support plane. 36A and 36B illustrate a catheterization system 100a including a catheterization tray 200a for securing the catheter assembly and/or one or more components or elements for a catheterization procedure. Except as described herein, catheterization system 100a and its elements and components may be similar or identical to catheterization system 100 and its elements or components of FIG. 30A. For example, except as described herein, catheterization tray 200a and the catheterization elements and components included in catheterization tray 200a may be similar to those of catheterization tray 200 and therein of FIGS. 31A-32 . It may be similar to catheterization elements or components.

For example, as shown in FIG. 36A, catheter insertion tray 200a may have a generally rectangular shape that may be defined by sides 201a-204a. The sides 201a to 204a may be substantially planar and thus may define a box-like structure or perimeter of the catheterization tray 200a. Catheterization tray 200a may further include an upper compartment 210a that may contain instructions and/or one or more catheterization components. In one embodiment, upper compartment 210a may be defined by partitions 211a, 212a and lower portion 213a. In one embodiment, partitions 211a, 212a and/or lower portion 213a may be removable from catheterization tray 200a.

In one embodiment, removal of partitions 211a, 212a and/or lower portion 213a may provide access to additional catheterization components in catheterization tray 200a. For example, as shown in FIG. 36B, after removing the partitions 211a, 212a and lower portion 213a of FIG. 36A, the central compartment 220a of the catheterization tray 200a may be exposed and accessible to the user. may be accessible to For example, compartment 220a may store or contain catheter assembly 190. In one embodiment, compartment 210a may be separated from adjacent compartments by one or more partitions (eg, by partitions 221a, 222a). As mentioned above, the catheter assembly 190 in compartment 210a may be positioned approximately perpendicular to a support plane (e.g., catheterization tray 200a may be placed on a support plane, such as the surface of a patient bed). at the time).

In one embodiment, partitions 221a and 222a may separate central compartment 220a from adjacent compartments 230a and 240a. Sections 230a and/or 240a may contain various catheterization elements or components for the procedure, which may be similar or identical to the catheterization components described above with respect to catheterization tray 200 of FIGS. 31A-32. It can contain or contain things. In some examples, partitions 221 and/or 222a may be removable from catheterization tray 200a, which may assist in removal of catheterization elements or components from catheterization tray 200a.

Catheter insertion tray 200a may be made of any suitable material. For example, the catheter insertion tray 200a may be made of a thick sheet-like material or panels (eg, a plastic material). For example, the thickness of the panels may be in one or more of the following ranges: about 0.1 inch to about 0.2 inch; About 0.15 inches to about 0.3 inches; About 0.25 inches to about 0.5 inches. However, the thickness of the panel should be understood to be thinner than 0.1 inch and thicker than 0.5 inch. Additionally, catheterization tray 200a may be reused following a catheterization procedure (eg, catheterization tray 200a may be disinfected and/or repackaged for reuse).

In one embodiment, the catheterization tray can be at least partially disassembled (eg, in addition to or instead of removing the partitions). 37A shows a catheterization system 100b that can include a catheterization tray 200b that can be deployed to access the contents therein. As mentioned above, catheterization system 100b can include a catheterization tray 200b that can be wrapped within a CSR sterile wrap 130b that can be unwrapped to access catheterization tray 200b. For example, initially the flap or portion 131b of the CSR sterilizing wrap 130b may be unfolded toward the patient (e.g., thereby covering the support plane with the sterile portion 131b of the CSR sterilizing wrap 130b). ).

In one embodiment, CSR sterilizing wrap 130b may include a pocket 132b that can be exposed when CSR sterilizing wrap 130b is unwrapped to expose catheter insertion tray 200b. In one embodiment, used items or waste may be placed in pocket 132b during and/or after the catheterization procedure. As a result, the waste is discharged together with the CSR sterilization wrap (130b).

A drape (e.g., fenestrated drape 270) is attached to CSR sterile wrap 130b such that after unwrapping CSR sterile wrap 130b, the drape is exposed and removed from CSR sterile wrap 130b for catheterization procedures. can be used for In one embodiment, the fenestration drape 270 may be attached to the CSR germicidal wrap 130b in any suitable manner that may vary from embodiment to embodiment. In one example, the fenestration drape 270 may be attached to the CSR disinfection wrap 130b with light adhesive, tape, tabs, etc.

As mentioned above, the catheterization tray 200b may be exposed after unwrapping the CSR sterilization wrap 130b. Catheterization tray 200b may include one or more identifiers 260b that may identify or suggest the sequence of steps and/or use of catheterization components in a catheterization procedure (e.g., identifiers 260b may identify or suggest the use of catheterization components in a catheterization procedure). may be on one or more external surfaces of tray 200b). For example, identifiers 260b may be located on the upper surface of catheterization tray 200b and may indicate additional steps of the catheterization procedure. According to one embodiment, the top panel 201b of catheterization tray 200b can be opened to unfold catheterization tray 200b and access catheterization components within catheterization tray 200b.

As shown in FIG. 37B, after opening catheterization tray 200b, the user can access compartment 210b, which may contain catheter assembly 190 for a catheterization procedure. For example, the top panel 201b connected to and provided with the side panel 202b may be unfolded away from the panels 203b, 204b, and 205b. More specifically, side panels 203b, 204b and stiffening ribs 205b may partially define the perimeter of compartment 210b. Unfolding the side panel 202b and the top panel 201b from the side panels 203b, 204b, 205b creates a partition through the side (with the side panel 202b unfolded) and the top (with the top panel 201b removed). May provide access to (210b). In one embodiment, side panels 202b and top panel 201b can be unfolded in a general direction away from or facing the insertion point (eg, in a manner that does not interfere with the catheterization procedure).

Additionally, at the interior surface of panel 201b, catheterization tray 200b may include additional or alternative catheterization components, such as syringe 170 or swabs 150. These catheterization components may be attached or secured to the top panel 201b and/or side panels 202b. For example, syringe 170 may be secured to top panel 201b with one or more straps 220b. Additionally, in some examples, the swabs 150 may be secured to the top panel 201b within one or more pockets 230b. Catheterization components (such as syringe 170, swabs 150, etc.) may be attached or secured to top panel 201b in any number of suitable ways and with any number of suitable mechanisms (e.g., adhesive, tabs, etc.) . In any case, catheterization components secured to the interior of top panel 201b and/or side panel 202b may be removable and accessible from side panels 203b, 204b, 205b after unfolding them.

Additionally, side panel 202b and/or top panel 201b may include one or more procedural indicators 260b proximate one or more corresponding catheterization components. For example, procedural indicators 260b may identify catheterization components with a number that corresponds to the number of steps in a proposed sequence of steps for a catheterization procedure. Additionally, the catheter insertion components and corresponding procedural indicators 260b are arranged in a sequential manner, such that higher numbered indicators and corresponding catheter insertion components are generally located farther from the insertion area. That is, catheterization components used later in the catheterization procedure (based on the placement of the catheterization tray 200b) will be located farther from the insertion point, and catheterization components used earlier in the catheterization procedure will be closer to the insertion point. You can.

In one embodiment, catheterization tray 200b may include a horizontal panel 207b that may extend from and connect to side panel 204b (e.g., horizontal panel 207b may be folded into compartment 210b). and/or may be substantially parallel to the support plane supporting the catheterization tray 200b). In some examples, horizontal panel 207b may support and/or secure one or more catheterization components. For example, horizontal panel 207b can be removed therefrom to secure lubricant and pouch 180b that can be used in a catheterization procedure.

In one embodiment, side panel 204b and horizontal panel 207b can be spread away from side panels 203b and 205b, as shown in Figure 37C. For example, unfolding side panel 204b may provide access to compartment 210b. Additionally, one or more catheter insertion sections may be attached to the inner surface of the side panel 204b and/or the horizontal panel 207b at its inner surface. For example, disinfectant packet 160 may be attached (e.g., with a light adhesive) to horizontal panel 207b and/or side panel 204b. Additionally, the catheterization tray 200b may include an indicator 260b that identifies a specific order or location or step in the sequence of the catheterization procedure in which the disinfectant packet 160 may be used.

As described above, the catheterization system can include a catheterization tray wrapped in sterile wrap that can be used during catheterization procedures. A catheterization system may include one or more catheterization components secured to and/or wrapped by a sterile wrap. Such catheterization systems can reduce waste or materials discarded after a catheterization procedure. For example, after completing the catheterization material, the sterile wrap can be disposed of and/or composted to reduce long-term waste from the catheterization system.

In accordance with the above, Figures 38a, 39a, 40a, 41a, 42a and 43a illustrate medical procedure packages (e.g., catheterization trays for catheterization packages) according to some alternative embodiments of the previously described medical procedure trays. Provides medical procedure trays for. For ease of explanation, alternative embodiments that share the medical procedure tray previously detailed above will not similarly be described below. The description of each shared feature should be understood to be appropriately incorporated by reference by the name of the shared feature when describing alternative embodiments. For additional ease of explanation, not all features of the alternative embodiment that are shared with the previously described medical procedure trays are described further. Instead, shared visual elements between alternative embodiments and the previously described medical procedure trays should be understood as representing shared features between the alternative embodiments and the previously described medical procedure trays. do. Accordingly, the shared visual elements provide a basis for including, by reference, a description of each of the shared features as appropriate for alternative embodiments. For example, FIGS. 2 and 38A provide medical procedure trays including stiffening lips (see stiffening lips 20 of FIG. 2 and descriptions thereof). Although the stiffening ribs of the alternative embodiment of Figure 38A are not explicitly described, the description for the stiffening ribs is incorporated by reference in light of the shared visual elements representing the stiffening ribs.

Figure 38A shows a diagram 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 with cover 3801. Figure 38D shows another view of the medical procedure tray 3801 of Figure 38A with a cover 3801.

The medical procedure tray 3800 of FIGS. 38A, 38B, 38C, and 38D may include a first section 3810, a second section 3820, and a third section 3830. As described herein, a section of a medical procedure tray may be designed for one or more specific purposes (e.g., a pit for iodine, a section for storage, etc.), and the section may be at least partially divided entirely from one or more other sections. and may be separated by one or more physical features (e.g., one or more partitions), thereby forming a compartment for one or more specific purposes. As shown, medical procedure tray 3800 may include a first partition 3842 formed from the medical procedure tray 3800 itself. The side facing the first partition or at least the first section of the first partition 3842 (see FIG. 38A) is at an end of the medical procedure tray 3800 that includes at least the second section 3820. It has a first height h1 equal to the height of (3800). The first partition 3842, or at least the side facing the first section of the first partition (see FIG. 38A), has a second height lower than the first height at the end of the medical procedure tray 3800 opposite at least the second section. It has height h2. In terms of first partition 3842, first section 3810 can be thought of as a first compartment 3810 that is at least partially separate from third section 3830 and entirely separate from second section 3820. there is. As also shown, medical procedure tray 3800 may include a second partition 3844 formed from medical procedure tray 3800 itself. The side facing the second partition 3844, or at least the third section of the second partition 3844 (see FIGS. 38A and 38B), has a first height equal to the height of the medical procedure tray 3800. In terms of the first partition 3842 and the second partition 3844, the second section 3820 may be considered a second compartment 3820 completely separate from the first section 3810 and the third section 3830. You can. Additionally, in view of the first partition 3842 and the second partition 3844, the third section 3830 is at least partially separate from the first section 3810 and entirely from the second section 3820. Can be considered partition 3830.

With the previously described medical procedure tray, medical procedure tray 3800 may include medical procedure instructions printed directly on medical procedure tray 3800, at least some of which appear according to the steps of the medical procedure. You can. If the medical procedure tray 3800 is included in a medical procedure package with the contents of the medical procedure (e.g., a drainage system containing a catheter for a catheterization procedure, a lubricant container, a syringe of water, a skin preparation kit, etc.) , step-by-step removal of contents may reveal step-by-step instructions for a medical procedure printed on the medical procedure tray.

For first section or compartment 3810, the first section may be configured to receive a first set of contents for a medical procedure. In some embodiments, the medical procedure is a catheterization procedure and the first set of contents may include, but is not limited to, a catheter (eg, a Foley catheter), drain tubing, and a drain bag. The first set of contents may further include a syringe of sterile water for inflating a balloon, such as the balloon of a Foley catheter. When medical procedure tray 3800 is included in a medical procedure package, first section 3810 may include a first set of contents. For visual reference, the medical procedure tray 3800 of FIGS. 38A, 38B, 38C, and 38D is shown with a syringe 3892 of sterile water. As shown in FIGS. 38A and 38B, the syringe of sterile water 3892 may simply be placed along the interior wall of the medical procedure tray 3800, or may be fitted with a loose fit of a clamp fit at both ends of the syringe of sterile water 3892. It can be located along an interior wall. As shown in FIGS. 38C and 38D, the syringe 3892 of sterile water may still be placed along the interior wall of the medical procedure tray 3800; However, the syringe 3892 of sterilizing water may be further positioned within the retainer 3803 or folded portion of the cover 3801.

38C and 38D, the medical procedure tray 3800 may include a cover such as a packaging label 62 described with reference to FIGS. 11 and 12, an identification cover 120 described with reference to FIG. 30A, or a combination thereof. is shown with As further shown, cover 3801 can be folded to form a retainer 3803 for retaining any contents of the medical procedure package in the first section. For example, retainer 3803 may be configured to keep a syringe of sterile water 3892 in the first section away from any other contents of the medical procedure package in the first section. Different portions of cover 3801 may be folded to form different retainers for retaining the contents of the medical procedure package in appropriate sections. As shown, cover 3801 can be configured to fit within first section 3810 of medical procedure tray 3800; However, cover 3801 may alternatively be configured to fit within the first section and additional sections of medical procedure tray 3800 or portions thereof (e.g., second section 3820, third section (3830), etc.). Cover 3801 may alternatively be a medical procedure tray 4100, except that portions of the cover 3801 that are folded or otherwise shaped form retainers for retaining the contents of the medical procedure package in appropriate sections. It can be configured to fit any previous configuration, up to and including the entire medical procedure tray 4100.

Regarding the second section or compartment 3820, the second section 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 a Foley catheter). When medical procedure tray 3800 is included in a medical procedure package, second section 3820 may include a second set of contents. For visual reference, the medical procedure tray 3800 in FIGS. 38A and 38B is shown with a container 3894 of lubricant.

In the configuration of the second section or compartment 3820 for the second set of contents, the second section 3820 provides open access for easy removal of the second set of contents while simultaneously containing the second set of contents. It may be configured as a retainer to hold or otherwise retain (e.g., a container 3894 of lubricant). The second partition 3844 formed from the medical procedure tray 3800 has the previously described first height (e.g., equal to the height of the medical procedure tray 3800) and the third height of the second partition 3844. The section may have on the facing side (see Figures 38a and 38b); However, the second partition 3844 may further have a second height on the side 3844 facing the second section of the second partition. on the side facing the second section of the second partition 3844, resulting in raising the lower part 3822 of the second section 3820 above the lower part 3812 of the first section 3810 or the tray 3800 ( 38B) the second height may be lower than the first height on the side facing the third section of the second partition 3844. Again, for visual reference, the medical procedure tray 3800 of FIGS. 38A and 38B is shown with a container 3894 of lubricant. The container 3894 of lubricant is positioned at a location along the interior wall (or protrusion thereof) of the medical procedure tray 3800 shared with the second section 3820 and the second section facing side of the second partition 3844. , with a clamp fit on both sides of the container of lubricant 3894, at both ends of the container of lubricant 3894, or a combination thereof. A lower portion 3822 of the second section 3820 rising from the bottom of the first section 3810 or tray 3800 provides open access for easy removal of the second set of contents.

Regarding the third section or compartment 3830, the third section may be configured to receive a third set of contents for a medical procedure. In some embodiments, the medical procedure is a catheterization procedure and the third set of contents includes a specimen container, optionally a label for the specimen container, a sterile solution (e.g., povidone-iodine, iodine tincture, aqueous iodine) A skin preparation kit containing a packet of iodophor, etc., and one or more swabs. If medical procedure tray 3800 is included in a medical procedure package, third section 3830 may include a third set of contents. The medical procedure tray 3800 of FIGS. 38A and 38B is shown without a specimen container or skin preparation kit; However, FIGS. 8, 26, and 27 provide visual references for including one or more swabs in the medical procedure tray 3800, and FIGS. 25-29 include a specimen container in the medical procedure tray 3800. 25 provides a visual reference for including a packet 52 of sterile solution in a medical procedure tray 3800.

In constructing the third section or compartment 3830 for the third set of contents, the third section 3830 may be comprised of one or more additional sub-sections or sub-compartments. As shown in FIGS. 38A and 38B, one or more additional sub-sections or sub-compartments may include a swap compartment 3832, an overflow compartment 3834, and a corner storage compartment 3836. Swap compartment 3832 consequently includes one or more pits 3831 and one or more channels, one of which has been designated as channel 3833. Pit 3831 may be located at the bottom of second partition 3844 separating second section 3820 from third section 3830 as shown in FIGS. 38A and 38B. Pit 3831 may also be located in the bottom of one or more channels, thereby bordering each of the one or more channels at its pit end. Pit 3831 may be configured to contain a fluid, such as a sterile solution of a medical procedure package, when poured therein.

The one or more channels may be configured to each hold one or more swabs of the skin preparation kit for subsequent use, each with a packet of sterile solution. Each of the one or more channels may optionally be configured to hold a respective swab of one or more swabs under at least one snap-in feature or snap-in tab located along the length or longitudinal side of the channel. Any two or more snap-in tabs, such as any three or more snap-in tabs, and any four or more snap-in tabs, for example located along the length or longitudinal side of the channel, may be staggered with respect to each other. . As shown in FIGS. 38A and 38B, each channel of the one or more channels may include three snap-in tabs along its longitudinal sides (see further FIG. 8 and its description). Each channel of the one or more channels may be further configured to be tilted or angled relative to the lower portion 3812 of the tray 3800. Additionally, each of the one or more channels is bordered by a pit 3831 at its pit end and is configured in a delta or delta shape. With this configuration, the handle end of the swab held below the snap-in tabs of the channel can rise against the absorbent end of the swab when the absorbent end is positioned in the receiving delta for it. As such, the absorbent head of the swab can be tilted down into the pit 3831 of the swab compartment 3832 of the third section 3830 and the elongated member of the swab can be positioned in a tray 3800 and a medical procedure package including the swab. can be tilted upward for gripping and removal at the appropriate stage of removal from the box.

Overflow section 3834 may be located at the end of one or more channels opposite pit 3831. Overflow section 3834 may be fluidly connected to pit 3831 through one or more channels, each of which may flow (e.g., and may be further configured to carry a sterile solution of a skin preparation kit. Medical procedures may require additional sterile solution for skin preparation or similar, where additional sterile solution exceeds the total volume of swab compartment 3832 (e.g., the combined volume of pit 3831 and one or more channels). A volume of sterile solution can be safely added to pit 3831 with assurance that it can flow through one or more channels to overflow compartment 3834.

For the corner storage compartment 3836, the corner storage is located between the overflow compartment 3834 and the interior wall 3800 of the tray, thereby sharing the interior wall of the tray 3800. Corner storage compartment 3836 can be configured to accommodate specimen containers of medical procedure packages. Additionally, the medical procedure package may include packets of sterile solution within or on the swap compartment 3832 and overflow compartment 3834 as shown in FIG. 25 , but the corner storage compartment 3836 may contain packets of sterile solution. It may be further configured to accommodate at least a portion of. In this configuration, packets of sterile solution in a tray 3800 containing medical procedure packages may be placed within or on a swap compartment 3832, an overflow compartment 3834, a corner storage compartment 3836, or a combination thereof. .

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

The medical procedure tray 3900a of FIGS. 39A and 39B may have a similar configuration to the medical procedure tray 3800 described with reference to FIGS. 38A, 38B, 38C, and 38D. As such, tray 3900a may similarly include a first section or first compartment 3910, a second section or second compartment 3920, and a third section 3930 of the third compartment, Each may be configured to receive and hold contents for medical procedures. However, as shown, the first section 3910 of the tray 3900a may have a different configuration than the first section 3810 of the tray 3800. For example, the first section 3810 of tray 3800 in FIGS. 38A, 38B, 38C and 38D has a more square shaped space, whereas the first section 3810 of tray 3900a in FIGS. 39A and 39B has a more square shaped space. The first section 3910 has a more rectangular shaped space. This means that the sides of the tray 3900a for the first session 3910 (e.g., the side of the tray 3900 adjacent to the syringe 3892 of sterilizing water and the side opposite thereto) are in the first section 3810. This is because it is longer than similar sides of the tray 3800. Configuring first section 3910 in this manner allows for a relatively larger capacity for the relatively larger contents of the medical procedure package including tray 3900a.

Not only does the first section 3910 of the tray 3900a have a different configuration than the first section 3810 of the tray 3800, but one or more partitions of the tray 3900a are similar to one or more partitions of the tray 3800. It can have different configurations. Although not shown in FIGS. 39A and 39B, a different configuration may be that compared to one or more partitions of tray 3800, where one or more partitions may have a height equal to the height of the tray (e.g., maximum height), the tray Shorter heights for one or more partitions of 3900a may be included, either proportionally or non-proportionally. As an example of a non-proportionally short height, the first partition 3942 of the tray 3900a may have a non-proportionally short height compared to the first partition 3842 of the tray 3800, and a similar first partition The first height h1 of 3942 may be shorter than the first height h1 of the first partition 3842, and the similar second height h2 of the first partition 3942 may be shorter than the first height h1 of the first partition 3842. ) may be substantially the same as the second height (h2). FIG. 41B is not proportional to first partition 3842 of tray 3900a, with the understanding that the first partition 3942 of tray 3900a continues with the interior wall of tray 3900a as shown in FIGS. 39A and 39B. This provides a visual reference to the first partition 3942 having a shorter height. As an example of a proportionally shorter height, the second partition 3944 of tray 3900a may have a proportionally shorter height compared to the second partition of tray 3800. 41B provides further visual reference to this proportionally shorter height of second partition 3944 compared to second partition 3844. Configuring one or more partitions of tray 3900a at a proportionally or disproportionately shorter height relative to one or more partitions of tray 3800 still provides open access for easy removal of the container of lubricant 3894. While providing this, the lower part of the second section 3920 may be lower than the lower part of the second section 3820 of the tray 3800. For example, the lower portion of the second section 3920 may be substantially coplanar with the lower portion of the first section 3910 or the lower portion of the tray 3900a. 41B shows the second section 3920 of tray 3900a, with the understanding that the first partition 3942 of tray 3900a continues with the interior wall of tray 3900a as shown in FIGS. 39A and 39B. Provides a visual reference to these subdivisions. The embodiment of the coplanar lower portion of the second section 3920 of the tray 3900a and the embodiment of the raised lower portion 3822 of the tray 3800 both allow for lubricant to settle too deeply within the pits of the second section. Not having a container 3894 provides open access for easy removal of the container 3894 of lubricant.

Embodiments may include a raised second section bottom of the tray (e.g., raised bottom 3822 of second section 3820 of tray 3800) and a second section bottom coplanar with the bottom of the tray (e.g., , the coplanar lower portion of the second section 3920 of the tray 3900a), but the lower portion of any compartment of any medical procedure tray disclosed herein may be as described for the trays 3800 and 3900a. It should be understood that they may be different.

FIG. 39C shows a diagram of a medical procedure tray 3900b including multiple retainers in a first configuration according to some embodiments.

The medical procedure tray 3900b of FIG. 39C may have a similar configuration to the medical procedure tray 3900a described with reference to FIGS. 39A and 39B. As such, tray 3900b similarly includes a first section 3910, a second section 3920, and a third section 3930, each of which can be configured to receive and hold contents for a medical procedure. can do. However, as shown, the first section 3910 of tray 3900b may have a different configuration than the first section 3910 of tray 3900a. For example, the first section 3910 of tray 3900b in FIG. 39C may include many retainers, with one retainer indicated as retainer 3912. In contrast, the first section 3910 of tray 3900a in FIGS. 39A and 39B is shown without numerals of retainers; However, tray 3900a, and any tray provided herein, may optionally include one or more retainers of any type provided herein. A number of retainers in the first section 3910 of the tray 3900b may be used to retain any contents of the medical procedure package in the first section 93910. For example, a number of retainers may be configured to keep the syringe 3892 of sterile water in the first section 3910 away from any other contents of the medical procedure package in the first section 3910. there is. It can be formed from any of many different types of retainers (e.g., column or tapered column type retainers, rack type retainers, tab type retainers, removable retainers, etc.). Any number of retainers (e.g., 1, 2, 3, 4, or 5 or more retainers) may be formed - some of the retainers may be formed from the tray 3900b itself. You can. As shown in FIG. 39C , the first section of tray 3900b may include at least three pillar-type retainers equidistant from the side of tray 3900b adjacent the syringe 3892 of sterile water.

FIG. 39D shows a diagram of a medical procedure tray 3900c including multiple retainers in a second configuration according to some embodiments.

The medical procedure tray 3900c of FIG. 39D may have a similar configuration to the medical procedure tray 3900b described with reference to FIG. 39C. As such, tray 3900c similarly includes a first section 3910, a second section 3920, and a third section 3930, each of which may be configured to receive and hold contents for a medical procedure. can do. However, as shown, the first section of tray 3900c may have a different configuration than the first section of tray 3900b. For example, the first section 3910 of tray 3900c in FIG. 39D may have at least three column type retainers, one retainer indicated as retainer 3912 and another retainer indicated as retainer 3913. there is. However, unlike the at least three tapered column type retainers equidistantly spaced from the side of tray 3900b, at least one (e.g., retainer 3913) of the at least three column type retainers of tray 3900c may be offset from others, as shown by the dotted line. These other configurations may further limit the degree of freedom of any type of content (e.g., sterile water syringe 3892) of the medical procedure package in first section 3910. As such, this different configuration may further separate any of these contents within first section 3910 from any other contents of the medical procedure package in first section 3910.

FIG. 40A shows a diagram 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 of FIGS. 40A and 40B may have a similar configuration to the medical procedure tray 3900a described with reference to FIGS. 39A and 39B. As such, the tray 4000, each configured to receive and hold contents for a medical procedure, has a first section or first compartment 4010, a second section or second compartment 4020, and a third section or third compartment. Compartment 4030 may similarly include. However, as shown, the second section 4020 of the tray 4000 may have a different configuration than the second section 3920 of the tray 3900a. For example, the second section 3920 of tray 3900a may have a second section of tray 4000 that terminates in a common partition for both the second section 3920 and third section 3930 of tray 3900a. Second section 4020 may be an extended section extending into first section 4010. The extended second section 4020 of the tray 4000 has an extended second partition extending from the first section 4010 of the tray 4000 to the first section 4010 and terminating at a third partition 4046. 4044). Additionally, the first partition 4042 separating the third section 4030 from the first section 4010 may terminate in the middle of the extended second partition 4044 instead of the interior wall of the tray 4000. . With the second section 4020 comprised of an extended section, the extended section 4020 can accommodate more contents, larger contents, or both, as needed for medical procedures. As shown, the extended second section 4020 includes a larger container of lubricant 4094 compared to the container of lubricant 3894 shown in FIGS. 39A and 39B.

FIG. 41A shows a diagram 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 FIGS. 41A, 41B, and 41C includes a first section 4110, a second section 4120, and a third section, each of which can be configured to receive and hold contents for a medical procedure. It may include section 4130. As described herein, a section of a medical procedure tray may be designated for one or more specific purposes, and a section may be designated at least partially (e.g., second section 4120) or entirely (e.g., second section 4120). Section 3 4130) may be separated from one or more sections by one or more physical features (e.g., one or more partitions), thereby forming a compartment for one or more specific uses. Additionally, second partition 4144 partially separates second section 4120 from first section 4110. Like the medical procedure tray 3800 of FIGS. 38A and 38B , the first partition 4142 of the tray 4100 (or at least the side facing the first section of the first partition 4142) is at a first height. (h1) and a second height h2 (see FIG. 41B), wherein the second partition 4144 (or at least the side facing the third section of the second partition 4144) has the first height. Can have (not shown). Unlike the tray 3800 of FIGS. 38A and 38B, the first height of the first partition 4142 and the first height of the second partition 4144 are lower than the height of the medical procedure tray 4100, as shown. In addition, the surface facing the second section of the second partition 4144 is coplanar with the bottom of the second section 4120 of the second partition 4144 and the bottom of the first tray section 4110 or the tray 4100. It may have the same height as the height of the side facing the third section being created.

For the first section 4110 of the tray 4100, the first section 4110 may be configured to receive a first set of contents for a medical procedure, such as a catheterization procedure. As previously described, the first set of contents includes a drainage system comprising a catheter (e.g., a Foley catheter), drainage tubing, a drainage bag, and a syringe 3892 of sterile water to inflate the balloon of the Foley catheter. It can be done, but it is not limited to this. For visual reference, sterile water syringe 3892 is different from the retainers (e.g., tapered column-type retainers) illustrated with reference to trays 3900b and 3900c of FIGS. 39C and 39D, respectively. The first section 4110 is shown mounted within or on a retainer (e.g., a rack-type retainer). As with the number of retainers in the trays 3900, the retainers for the syringes 3892 of sterile water are formed in the tray 4100 itself and hold the syringes 3892 of sterile water in the medical procedure package within the first section 4110. The syringe 3892 of sterilizing water may be simply placed in a retainer or rack, or the syringe 3892 of sterilizing water may be secured with a loose-fit clamp around the syringe 3892 of sterilizing water. It can be fitted into a retainer or rack by means of a snap fit.

Regarding the second section 4120 of the tray 4100, the second section 4120 may be configured to receive a second set of contents for a medical procedure, such as a catheterization procedure. 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 a Foley catheter), such as a syringe 4194 of lubricant. For visual reference, the syringe 4194 of lubricant may be replaced with a retainer 4114 (e.g., a rack-type retainer) as described with reference to the retainer in the first section 4110 for the syringe 3892 of sterile water. ) is shown mounted in or on it. The syringes of lubricant 4194 may simply be placed on the retainer or rack 4194, or the syringes of lubricant 4194 may fit into the retainer or rack 4194 with a loose-fit clamp fit around the syringes of lubricant 4194. there is.

The retainer 4194 and the retainer for the syringe 3892 of sterilizing water may be the same or different as required by the size of the syringe 3892 of sterilizing water and the size of the syringe 4194 of lubricant required by the medical procedure. It can have dimensions. If the size of the lubricant syringe 4194 and the sterilizing water syringe 3892 are the same, the retainers or racks for this may have the same size, and the lubricant syringe 4194 and the sterilizing water syringe 3892 may have the same size. 3892 can, for example, interchange the placement of steps in a medical procedure within a medical procedure package to better coordinate them. Therefore, the second section is not limited to receiving and holding the syringe 4194 of lubricant, and the first section 4110 is not limited to receiving and holding the syringe 3892 of sterilizing water. The second section may be configured to receive and hold a syringe 3892 of sterilizing water, and the first section 4110 may be configured to receive a syringe 4194 of lubricant (the syringe 4194 of lubricant and the sterilizing water (even if the size of the syringe 3892 is different).

Regarding third section 4130, third section 4130 has an overflow, swap compartment 4132 configured as described herein to receive a third set of contents for medical procedures, such as catheterization procedures. It includes a furnace compartment 4134, and a corner storage compartment 4136. As previously described, the third set of contents includes a specimen container, a label for the specimen container (optionally), a sterile solution (e.g., an iodophor such as povidone-iodine, iodine tincture, aqueous iodine, etc.). Includes, but is not limited to, a skin preparation kit containing a packet and one or more swabs.The medical procedure tray 4100 of FIGS. 41A, 41B, and 41C serves as a template from which the third section 4130 is constructed. Shown without a container or skin preparation kit; however, FIGS. 8, 26, and 27 provide a visual reference for the inclusion of one or more swabs 34 in the swab compartment 4132, and FIGS. 25-29 provides a visual reference for the inclusion of specimen container 54 in corner storage compartment 4136, and FIG. 25 shows packets 52 of sterile solution in medical procedure tray 4100 in swap compartment 4132 and Provides a visual reference for inclusion above overflow compartment 4134.

Referring to Figure 41C, the medical procedure tray 4100 may include a cover, such as a packaging label 62 illustrated with reference to Figures 11 and 12, an identification cover 120 illustrated with reference to Figure 30A, or a combination thereof. 4101). As shown, cover 4101 can be configured to fit an entire medical procedure tray 4100; However, the cover 4101 is alternatively configured to fit a portion of the medical procedure tray 4100, the portion being separated from the first section 4110, second section 4120, and third section 4130. Contains one or more selected sections. Cover 4101 may alternatively be configured to fit within any configuration of medical procedure tray 4100, such as within the entire medical procedure tray 4100 or within a portion of the medical procedure tray 4100 ( For example, see cover 3801 in FIGS. 38C and 38D). As further shown, tray 4100 may be configured with optional supports 4102 in a first section of tray 4100. The support 4102 supports the caving of the cover 4101 and the tray 4100 under the cover when one or more medical procedure packages are stacked on top of the medical procedure package including the medical procedure tray 4100 and the cover 4101. Damage to the contents can be prevented. The support may be configured to a height substantially equal to the height of the tray 4100 and may be configured to be of sufficient width to support the weight of a stack of one or more medical procedure packages stacked thereon.

Figure 42A shows a diagram of a 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 FIGS. 42A and 42B may have a similar configuration to the medical procedure tray 4100 described with reference to FIGS. 41A and 41B. As such, tray 4200 may similarly include a first section 4210, a second section 4220, and a third section 4230, each configured to receive and hold contents for a medical procedure. The first section 4210 includes a drainage system comprising a catheter (e.g., a Foley catheter), drainage tubing, a drainage bag, and a syringe 3892 of sterile water for inflating the balloon of the Foley catheter, for example, as previously described. Can be configured to receive a first set of contents of a catheterization procedure comprising: For visual reference, syringe 3892 of sterile water is shown mounted within or on the rack-type retainer of first section 4210. Additionally, the first section may be configured with optional supports 4202A to prevent caving of the cover positioned thereon or thereover, as described herein. The second section 4220 contains a second set of contents for a catheterization procedure, including a lubricant (e.g., a lubricant for a Foley catheter), e.g., a syringe of lubricant 4194, previously described. It can be configured to accommodate. For visual reference, a syringe 4194 of lubricant is shown mounted within or on a rack-type retainer 4214 in second section 4220. A third section 4230 may contain, for example, a previously described specimen container, (optionally) a label for the specimen container, and a sterile solution (iodophor such as povidone-iodine, iodine tincture, aqueous iodine, etc.) and one. A swab compartment 4232, an overflow compartment 4234, and a corner storage compartment configured as described herein to accommodate a third set of contents for a catheterization procedure, including a skin preparation kit containing more than swabs. 4236).

With respect to the third section, however, the third section 4230 of the tray 4200 may, for example, have an inverted arrangement relative to at least one of the previous trays. It may have a different configuration from any one of the trays 3800, 3900A to 3900C, 4000, and 4100 in that it is located in the tray. For example, the placement of the third section 3830 of the tray 3800 may be such that the pit 3831 of the swap compartment 3832 or the pit end of the third section 3830 is adjacent to the second section 3820 of the tray 3800. It can be adjacent to . In such an arrangement, corner storage compartment 3836 shares an inner wall of tray 3800 with tray 3800 . Conversely, the inverted arrangement of the third section 4230 of the tray 4200 allows the pit (not shown) of the swap compartment 4232 or the pit end of the third section 4230 to be positioned between the trays 4200 and 4200. Share the inner wall. In this arrangement, corner storage compartment 4236 is adjacent second section 4220 of tray 4200. One or more trays provided herein, including one or more trays selected from trays 3800, 3900A-3900C, 4000 and 4100, may be configured in an arrangement with the third section inverted.

Referring to Figure 42B, a medical procedure tray 4200 may be equipped with a cover 4201, such as a packaging label described with reference to Figures 11 and 12, an identification cover 9120 described with reference to Figure 30A, or a combination thereof. It is shown. As shown, the cover 4201 can be configured to fit over the whole medical-procedure tray 4200; As shown, cover 4201 can be configured to fit an entire medical procedure tray 4200; However, cover 4201 may alternatively be configured to fit portions of medical procedure tray 4200, including first section 4210, second section 4220, and third section 4230. Contains one or more sections selected from. Cover 4201 is alternatively configured to fit within medical procedure tray 4200 in any of the previous configurations, such as within a portion of medical procedure tray 4200 or within entire medical procedure tray 4200. It can be. (See, for example, cover 3801 of FIGS. 38C and 38D.) As further shown, tray 4200 is a second portion of tray 4100. It may be configured in first section 4110 with optional support 4202A of FIG. 42A and optional support 4202B shown elsewhere in first section 4110. Optional supports 4202A and 4202B may be positioned differently depending on packaging and stacking needs. A support, such as support 4202B, supports the caving of the cover 4201 and the tray beneath it when one or more medical procedure packages are stacked in a medical procedure package including the medical procedure tray 4200 and the cover 4201 ( 4200) can prevent damage to the contents. Each of supports 4202A and 4202B can be configured to a height substantially equal to the height of tray 4200 and can be configured with a width sufficient to support the weight of a stack of one or more medical procedure packages stacked thereon.

Figure 43 shows a diagram of another medical procedure tray 4300 according to some embodiments.

The medical procedure tray 4300 of FIG. 43 may have a similar configuration to the medical procedure tray 4200 described with reference to FIGS. 42A and 42B. As such, tray 4300 may similarly include a first section 4310, a second section 4320, and a third section 4330 in the inverted arrangement described with reference to tray 4200. . Each of the first section 4310, second section 4320, and third section 4330 may be configured to receive and hold contents for medical procedures. First section 4310 includes a drainage system including, for example, a previously described catheter (e.g., a Foley catheter), drainage tubing, a drainage bag, and a syringe of sterile water to inflate the balloon of the Foley catheter. and may be configured to receive a first set of contents for a catheterization procedure. Although not shown, the first section 4310 may be configured with a tab-type retainer for holding or otherwise retaining a syringe of sterile water. The second section 4320 may contain a lubricant (e.g. For example, a lubricant for a Foley catheter). The inverted arrangement of third section 4330 may include, for example, a specimen container, optionally a label for the specimen container, and a packet of sterile solution (e.g., povidone-iodine, iodine tincture, aqueous iodine), as previously described. A swab compartment 4332, an overflow compartment 4334, and a corner storage compartment configured as described herein to accommodate a third set of contents for a catheterization procedure, including iodophor, etc.) and one or more swabs. 4336). Like tray 4200 of FIGS. 42A and 42B, corner storage compartment 4336 is adjacent second section 4320 of tray 4300; However, the second section 4320 of the tray 4300 extends completely from the interior wall of the first section 4310 of the tray 4300 to the opposite interior wall of the tray 4300 shared by the third section. The second section 4220 of the tray 4200 does not. That is, the second section 4220 of the tray 4200 may similarly be configured to extend completely from the first section of the tray 4200 to the opposite interior wall of the tray 4200 that is shared by the third section 4230. You can.

FIG. 44A shows a diagram of a removable retainer 4412 on a partition or side of a medical procedure tray according to some embodiments. FIG. 44B shows another view of a removable retainer 4412 on a partition or side of a medical procedure tray with hidden tabs of instructions, according to some embodiments. FIG. 44C shows another view of a removable retainer on the side or partition of a medical procedure tray with tabs exposing instructions according to some embodiments.

Any medical procedure tray provided herein may optionally include at least tapered column-type retainers, rack-type retainers and tab-type retainers for retaining any contents of the medical procedure package in appropriate sections. Any number of retainers of any type selected may also be included. For example, the tray 3900a has a tray 3900b with three tapered column-type retainers therein holding a syringe 3892 of sterilizing water in one section 3910 and another in the first section 3810. It may include three tapered column-type retainers that provide to secure or otherwise maintain the contents apart from other contents of the medical procedure packages containing the contents. (See FIG. 39C and retainer 3912 in first section 3910 holding syringe 3892) Additionally, any medical procedure tray provided herein may store any contents of one or more medical procedure packages in appropriate sections. It may optionally include one or more subtypes of retainers for securing to the device. For example, as shown in FIG. 45 , accessory type retainer 4512 includes a clip section 4593 for clipping a syringe 3892 of sterile water (or container 3894 of lubricant) to accessory-type retainer 4512. The accessory-type retainer 4512 may include an additional belt or strap section for attaching the clip section to a tray (e.g., the side of the tray shown) or a cover therefor (e.g., the underside of the cover). (4514) may be included. Instructions for one or more steps of a medical procedure may be printed on a visible surface of belt or strap section 4514.

Depending on whether the medical procedure tray includes any of the previous retainers (e.g., column or tapered type retainers, rack-type retainers, tab-type retainers, and accessory-type retainers). , a medical procedure tray may include one or more removable retainers. An example of a removable retainer is the removable retainer 4412 of FIGS. 44A, 44B, and 44C that is configured to keep a syringe 3892 of sterile water and a container 3894 of lubricant away from other contents of the medical procedure package. However, it should be understood that removable retainers are not limited to removable retainer 4412. For example, the removable retainer may be configured to hold only a container 3894 of lubricant or only a syringe 3892 of sterile water. Additionally, the removable retainer may be configured to retain other contents of the medical procedure package in appropriate sections therefor.

44A, 44B, and 44C, a removable retainer, such as removable retainer 4412, includes a removable clip 4414 for removably attaching the removable retainer to a partition or side of a medical procedure tray. Can contain the same clip. The clip is configured to clip the removable retainer to the side of the medical procedure tray or the removable retainer so that the removable retainer is attached to the interior of the medical procedure tray (e.g., packaged) or to the exterior of the medical procedure tray ( For example, when used during medical procedures). The clip may be configured to clip the removable retainer to a partition or side of the medical procedure tray with a clip force sufficient to resist slideable movement of the removable retainer along the partition or side of the medical procedure tray. Alternatively, the clip may be configured to allow such slideable movement. When the clip is configured to permit slideable movement of the removable retainer along a partition or side of a medical procedure tray, less clip force or another captivating means other than the clip force may be used to ensure that the removable retainer can be carefully removed. Can be used to hold or secure a removable retainer on the side or partition of a medical procedure tray.

The slideable movement of the removable retainer may be used to reveal or hide instructions for one or more steps of a medical procedure. As shown in FIG. 44B, a removable retainer, such as removable retainer 4412, can be positioned on the interior of a medical procedure tray while hiding folded-down tabs of instructions for one or more steps of the medical procedure. Can be packaged. Although the adjacent instructions shown in FIGS. 44B and 44C are external to the medical procedure tray, the tray may alternatively be configured such that the folded tabs of the instructions are internal to the tray. Regardless of the external or internal configuration of the folded tab of the instructions, the removable retainer can be pushed aside as shown in Figure 44B to reveal the instructions, as shown in Figure 44C, which can be printed or stamped on the tab. The instructions can again be hidden by pushing their tab towards the inside or outside of the tray and sliding the removable retainer over it. Hiding instructions in a collapsed tab reduces the information a health care provider needs to know to only what is immediately needed to perform one or more immediate steps in a medical procedure. This, in turn, reduces errors in medical procedures. Additionally, the folded tabs of the instructions can hide sharp edges on the tabs that could threaten sterile packaging if left in an unfolded or extended position.

Again, the removable retainer 4412 of FIGS. 44A, 44B, and 44C is a removable retainer configured to keep the syringe 3892 of sterile water and the container 3894 of lubricant away from other contents of the medical procedure package. This is an example. As shown in FIGS. 44A, 44B, and 44C, the removable retainer 4412 has a first clip section 4493 for clipping a syringe 3892 of sterile water and a second clip section for a container 3894 of lubricant. It may include another, wider clip (e.g., wider than clip 4414) configured as 4495. Depending on the dimensions of the syringe 3892 of sterilizing water and the container 3894 of lubricant, the first clip section 4493 and the second clip section 4495 may have the same dimensions as each other or may have different dimensions from each other. . Regardless, a syringe 3892 of sterile water and a container 3894 of lubricant may be arranged in a removable retainer 4412 following one or more steps of a medical procedure. For example, instructions for one or more steps of a medical procedure may recommend connecting a syringe 3892 of sterile water to a Foley catheter in a first step, and the instructions may recommend lubricating the Foley catheter in a second step. I can recommend it.

Although the invention has been described in terms of specific variations or illustrated drawings, those skilled in the art will recognize that the invention is not limited to the depicted variations or drawings. Additionally, in steps and methods described above in which events occur in any order, those skilled in the art will recognize that any order of steps may be modified and such modifications may be made in accordance with variations of the present invention. will recognize that Additionally, any steps may be performed concurrently, if possible, in a parallel process, or sequentially as described above. Therefore, to the extent variations within the spirit or equivalents disclosed in the claims of the invention are intended, this patent covers such variations as well.

Claims (20)

As a catheterization package,
a tray comprising a first section, a second section, and a third section, one or more partitions separating at least the third section from the first section and the second section;
a drainage system including a catheter, drainage tubing, and drainage bag;
a syringe of sterilizing water, wherein at least the first section is configured to receive a syringe of sterilizing water together with the discharge system;
container containing a lubricant, wherein at least the second section is configured to receive the container containing the lubricant, and
i) the lower part of the first section is further from the upper part of the tray than the lower part of the second section, or
ii) each of said first section and said second section comprises a retainer along opposite longitudinal sides of said tray each containing said syringe of said sterilizing water and said container of said lubricant; or
iii) includes both i) above and ii) above-; and
A skin preparation kit comprising a package of sterilants and one or more swabs, wherein at least the third section is configured to receive the skin preparation kit, and wherein at least a portion of the tray is staged according to the steps of the catheterization procedure. Contains instructions for the catheterization procedure printed directly on the tray;
Contains and
The retainer is,
a first retainer comprising a clip removably attached to the opposite longitudinal side and configured to slide along the opposite longitudinal side, the first retainer being responsive to one or more steps of a medical procedure; Packaged inside the tray while hiding folded-down tabs of instructions, wherein sliding movement of the first retainer causes the folded-down tabs of instructions corresponding to one or more steps of the medical procedure. Revealing instructions corresponding to one or more steps of the medical procedure by revealing,
Catheterization package.
According to claim 1,
The lower portion of the first section is further from the upper portion of the tray than the lower portion of the second section.
Catheterization package.
The method of claim 1 or 2,
Partitions separating a second section of the one or more partitions further separate the second section from the first section,
The partitions separating the second section have a maximum height equal to the height of the tray,
Catheterization package.
According to claim 1,
wherein each of the first section and the second section includes a retainer along opposite sides of the tray each containing a syringe of the sterile water and a container of the lubricant.
Catheterization package.
According to claim 1 or 4,
second section-separating partitions of the one or more partitions further separate the second section from the first section;
the second section-separating partitions have a maximum height less than the height of the tray,
The lower part of the first section is coplanar with the lower part of the second section,
Catheterization package.
According to claim 1,
a swap compartment comprising one or more channels and pits each configured to hold one or more swaps with snap-in tabs therein;
an overflow compartment fluidly connected to the pit through the one or more channels, further configured to convey a sterilant poured therein to the pit; and
a corner storage compartment configured to accommodate a sample container;
Including,
Catheterization package.
According to claim 6,
wherein the one or more channels are angled relative to the bottom of the tray so that the handles of the one or more swabs are held below the snap-in tabs and rise relative to the absorbent head when the absorbent head end is in the depression.
Catheterization package.
According to claim 6,
A third section-separating partition of the one or more partitions at a pit end of the swap compartment directly separates the pit from the second section.
Catheterization package.
According to claim 6,
wherein the pit end of the swap compartment shares an inner wall of one of the longitudinal sides of the tray with a tray,
Catheterization package.
According to claim 1,
Further comprising a support in the first section,
The support has the same height as the tray and has sufficient width to withstand the weight of one or more catheterization packages stacked thereon.
Catheterization package.
According to claim 1,
a sterile wrap in a folded configuration around the tray;
a belly band outside the sterilization wrap for holding the sterilization wrap in the folded configuration around the tray, the belly band including instructions on how to position the tray prior to opening the sterilization wrap;
a packaging label outside the sterile wrap identifying the catheterization package, the packaging label containing information highlighting key features of the catheterization package in an easy-to-read manner;
containing
Catheterization package.
As a catheterization package,
a tray comprising a first section, a second section and a third section, one or more partitions separating the third section from the first section and the second section;
Drainage system including Foley catheter, drainage tubing, and drainage bag;
a syringe of sterile water for inflating the balloon of the Foley catheter, wherein at least the first section is configured to receive the drainage system and the syringe of sterile water;
a container containing a lubricant for a Foley catheter, wherein at least the second section is configured to receive the container containing the lubricant, and
i) the lower part of the first section is further from the upper part of the tray than the lower part of the second section, or
ii) each of said first section and said second section comprises a retainer along opposite longitudinal sides of said tray each containing said syringe of said sterilizing water and said container of said lubricant; or
iii) includes both i) above and ii) above-; and
A skin preparation kit comprising one or more swabs and a package of antiseptic agent,
Section 3 above:
a swap compartment comprising one or more channels and pits each configured to hold one or more swaps with snap-in tabs therein;
an overflow compartment fluidly connected to the pit through the one or more channels, further configured to convey a sterilant poured therein to the pit; and
a corner storage compartment, wherein the third section is configured to receive a package of sterilant on the swap compartment, the overflow compartment, the corner storage compartment, or a combination thereof;
Contains and
The tray includes instructions for the catheter insertion procedure printed directly on the tray, at least some of which are presented step by step according to the steps of the catheter procedure. do, and
The retainer is,
a first retainer comprising a clip removably attached to the opposite longitudinal side and configured to slide along the opposite longitudinal side, the first retainer being responsive to one or more steps of a medical procedure; Packaged inside the tray while hiding folded-down tabs of instructions, wherein sliding movement of the first retainer causes the folded-down tabs of instructions corresponding to one or more steps of the medical procedure. Revealing instructions corresponding to one or more steps of the medical procedure by revealing,
Catheterization package.
According to claim 12,
the bottom of the first section is farther from the top of the tray than the bottom of the second section,
second section-separating partitions of the one or more partitions further separate the second section from the first section;
The second section-separating partitions have a maximum height equal to the height of the tray,
Catheterization package.
According to claim 12,
each of the first section and the second section comprising a retainer along opposite longitudinal sides of the tray each containing the syringe of sterilizing water and the container of the lubricant, and
The lower portion of the first section is coplanar with the lower portion of the second section,
Catheterization package.
The method of claim 1 or 14,
Second section-separating partitions of the one or more partitions separate the second section from the first section, and
the second section-separating partitions have a maximum height less than the height of the tray,
Catheterization package.
As a package of medical procedures,
a tray comprising a first section, a second section and a third section, one or more partitions separating at least the third section from the first section and the second section;
a first set of contents for a medical procedure, wherein at least the first section is configured to receive the first set of contents;
a second set of contents for a medical procedure, wherein at least the second section is configured to receive the second set of contents, and
i) the bottom of the first section is further from the top of the tray than the bottom of the second section, or
ii) each of the first section and the second section comprises a retainer along opposite longitudinal sides of the tray each containing the first set of contents and the second set of contents, or
iii) includes both i) above and ii) above-; and
a third set of contents for medical procedures;
Including,
At least the third section is configured to receive a third set of contents, the third section comprising:
a swap compartment comprising one or more channels and pits each configured to hold one or more swaps with snap-in tabs therein;
an overflow compartment fluidly connected to the pit through the one or more channels, further configured to convey a sterilant poured therein to the pit; and
corner storage compartments;
Contains and
The tray includes instructions for a medical procedure printed directly on the tray, at least a portion of which is presented step by step according to the steps of the catheter procedure. do, and
The retainer is,
a first retainer comprising a clip removably attached to the opposite longitudinal side and configured to slide along the opposite longitudinal side, the first retainer being responsive to one or more steps of a medical procedure; Packaged inside the tray while hiding folded-down tabs of instructions, wherein sliding movement of the first retainer causes the folded-down tabs of instructions corresponding to one or more steps of the medical procedure. Revealing instructions corresponding to one or more steps of the medical procedure by revealing,
Package of medical procedures.
According to claim 16,
the bottom of the first section is farther from the top of the tray than the bottom of the second section,
The one or more partitions have a maximum height equal to the height of the tray,
Package of medical procedures.
According to claim 16,
each of the first section and the second section having a retainer along opposite longitudinal sides of the tray each containing the first set of contents and the second set of contents for a medical procedure; Contains and
The lower portion of the first section is coplanar with the lower portion of the second section,
Package of medical procedures.
The method of claim 16 or 18,
one or more partitions having a maximum height less than the height of the tray,
Package of medical procedures.
According to claim 16,
The medical procedure is a catheterization procedure,
The first set of contents for the catheterization procedure includes a Foley catheter, drainage tubing, a drainage bag, and a syringe of sterile water to inflate the balloon of the Foley catheter;
the second set of contents for the catheterization procedure includes a container containing a lubricant for a Foley catheter;
The third set of contents for the catheterization procedure includes a skin preparation kit including a package of sterilants and one or more swabs,
wherein the third section is configured to receive a package of sterile agent over the swap compartment, overflow compartment, corner storage compartment, or a combination thereof.
Package of medical procedures.