JP7013481B2 - Catheter insertion tray with integrated instructions - Google Patents

Description

[0001] This application claims the benefit of US Patent Application No. 15 / 487,297 filed on April 13, 2017, which was filed on April 14, 2016. It is a partial continuation of US Patent Application No. 15 / 029,613, which is the US domestic stage of International Patent Application No. PCT / US2014 / 060963 filed on October 16, 2014. The application benefits from US Provisional Patent Application No. 61 / 891,496 filed on October 16, 2013, and US Provisional Patent Application No. 62 / 015,206 filed on June 20, 2014. Is to insist. Each of these documents, in its entirety, is incorporated herein by reference.

[0002] Urinary drainage systems have long been used in hospitals and health care facilities when it is necessary to promote, manage and monitor a patient's urination, and when it is necessary to collect urine from a patient. .. These urine drainage systems allow the patient to stay in bed, eliminating the need to use a potty chair or move to use the toilet. Urine drainage systems include catheters (eg, intermittent catheters or urine catheters such as Foley catheters), collection vessels / bags (eg, bags made of polymer material or PVC film), urine meters, and Foley catheter collection vessels / bags. Alternatively, it may be equipped with a tube connecting to a urine meter and / or other equipment. During operation, the catheter is first introduced into the patient and the catheter is connected to the drainage vessel / bag and / or urine meter via a long tube (eg, a drainage tube). Urine drains through catheters and tubes and then finally enters the collection vessel / bag and / or urine meter. Urine can be moved from the catheter into the collection bag by gravity alone. On average, patients produce about 80-90 mL of urine per hour.

[0003] Accurate monitoring of urine helps clinicians detect abnormalities in urine flow or volume. These abnormalities can inform the clinician that the patient has certain problems. However, if the drainage system attached to the Foley catheter is not reliable, or if the Foley catheter and drainage system are not used properly, urine output cannot be measured accurately. Also, the beds used by hospitals are becoming lower and lower to reduce the number of injuries caused by falls. As lower beds are adopted, the height available to allow the pipe to drain is reduced. Drainage tubes and related venting systems used in hospitals have also undergone changes / modifications. The benching changes, coupled with the increasingly low floors of hospital beds, create suboptimal drainage performance. For example, it has been observed that urine stays in the tube. This hinders accurate measurement of urine output and flow, which is crucial for many patients.

[0004] 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 CAUTI rate by following strict sterility techniques as a medical standard. However, there are many factors that affect the ability of hospitals to meet this medical standard. These factors include health care practitioner / nurse experience and training, patient factors (eg, general health, weight and anatomy), environmental factors and tray placement, and content and Instructions / displays etc. are included. Catheter introduction packages and / or catheter introduction trays with procedure-optimized components and intuitive layouts can increase adherence to aseptic procedures that potentially reduce CAUTI rates.

[0005] In the field of health care, there is a need for a more reliable, safer and easier method for inserting a catheter such as a urinary catheter (eg, an indwelling catheter or an intermittent catheter) into a patient. More specifically, there is a need to provide a catheter introduction package and / or a catheter introduction tray (eg, Foley catheter tray) that improves and standardizes the process of inserting a urinary catheter, such as an indwelling Foley catheter, into a patient.

[0006] The present disclosure better meets the needs of patients, improves reliability and ease of use, reduces CAUTI cases, improves safety, and other issues mentioned above and elsewhere herein. Provided are catheter introduction packages, catheter trays and drainage systems configured to address the other issues described in.

[0007] The present specification describes embodiments such as packages, systems, trays, assemblies, devices, methods and the like used in general medical procedures, in particular for catheter introduction, and improvements to them.

[0008] An object described herein is achieved by providing an improved medical procedure package and / or a tray (eg, an improved catheter introduction package and / or an improved catheter introduction tray). Can be done. This improved medical procedure package can include an improved medical procedure tray in it, which can be arranged intuitively to understand the implementation and results of medical procedures. It may be provided with instructions or procedure indications for improvement. This medical procedure package and / or medical procedure tray can be equipped with various instruments and components necessary and / or useful for the medical procedure. For example, the improved catheter introduction package has an improved catheter introduction tray, iodine swabs or swab sticks that allow for greater coverage and saturation, improved efficacy and one-handed use. Hand sterilizers, tubes that cut off the surface tension of the fluid to improve drainage, and / or other components described herein can be provided.

[0009] According to various embodiments, the present disclosure provides a layout and / or arrangement of components that can help reduce the CAUTI rate by facilitating ease of use during insertion and supporting proper sterility techniques. A catheter introduction package and a catheter introduction tray to be provided are provided. The present disclosure further provides a catheter introduction method that can facilitate easier and more sterile catheter introductions that help reduce the CAUTI rate, as well as how to use the catheter introduction package and / or catheter introduction tray. do. Further, the present disclosure provides a system capable of improving drainage performance. This helps to (1) eliminate fluid in the drainage tube and (2) increases the accuracy of urine measurements (eg, discharge and flow rate measurements).

[0010] In some embodiments, a catheter introduction package is provided that includes a catheter introduction tray and a sterile wrap around the catheter introduction tray. The catheter introduction tray can include a catheter introduction instruction imprinted directly on the catheter introduction tray. The catheter introduction tray can also include a first section, a second section, and a third section, with one or more partitions having at least the third section from the first and second sections. Can be separated. The first section can hold the drainage system, the second section can hold the container containing the lubricant, and the third section can hold the swab in an inclined position. can. The swab's absorbent head can be angled downwards into the wells of the third section, and the elongated member of the swab is angled upwards for gripping and ejecting the swab. It is possible.

[0011] In such an embodiment, the catheter introduction package may further include a pericare kit, band, and packaging label. The pericare kit can be placed with the catheter introduction tray, but outside the sterile wrap. An example of a suitable pericare kit is disclosed in WO 2016/126555, the disclosure of which is incorporated herein by reference in its entirety. The band is on the outside of the sterile wrap and can hold the sterile wrap in a folded configuration around the catheter introduction tray. The packaging label can be on the outside of the sterile wrap to identify the catheter introduction package.

[0012] In such an embodiment, the third section of the catheter introduction package can include a swab compartment, an overflow compartment, and a square storage compartment for holding the sample container. The swab compartment can include wells and grooves, which are configured to hold the swab. The groove comprises at least two snap-fit tabs and can hold a swab in the groove under the snap-fit tab, and each longitudinal side of the groove is at least one of the two snap-fit tabs. Including one. The groove can be further configured to deliver the fluid to the wells when the swab is not in the groove and when the fluid is poured into the groove. The overflow compartment can be fluid connected to the well through the groove.

[0013] In such an embodiment, one or more partitions of the catheter introduction package that separates the third section from the first and second sections further separates the second section from the first section. be able to. The second section separation partition of one or more partitions can have a maximum height equal to the height of the catheter introduction tray and the bottom of the second section should be lifted above the bottom of the catheter introduction tray. Can be done. Alternatively, the second section-separated partition of one or more partitions can have a maximum height that is less than the height of the catheter introduction tray, the bottom of the second section, and the bottom of the catheter introduction tray. Are substantially coplanar.

[0014] In some embodiments, a medical procedure package is provided that includes a tray with medical procedure instructions imprinted directly on the tray, at least some of which are tailored to the medical procedure process. Is exposed. The tray can include a first section, a second section, and a third section, and one or more partitions separate at least the third section from the first and second sections. The tray can further include a drainage system, a container containing lubricant, and one or more swabs. The first section can contain at least a drainage system, the second section can contain at least a container containing a lubricant, and the third section can contain at least one or more swabs. can.

[0015] In such an embodiment, the medical procedure package may further include a sample container. The third section can include a swab compartment, an overflow compartment, and a square storage compartment containing a sample container. Swab compartments can include wells and one or more grooves so that one or more grooves hold one or more swabs in one or more grooves by snap fit tabs, respectively. It is configured in. Also, one or more grooves can be angled with respect to the bottom of the tray, and the handle end of each swab of one or more swabs held under the snap-fit tab is absorbent. It is designed to be lifted relative to the absorbent head end when the head end is in the well. Overflow compartments can be fluid connected to the wells through one or more grooves, one or more grooves in which one or more swabs are removed from one or more grooves. It can be further configured to deliver the poured fluid to the wells.

[0016] In such an embodiment, the medical procedure package provides a third section-separated partition of one or more partitions at the well end of the swab compartment that directly separates the well from the second section. Further can be included. Alternatively, the well end of the swab compartment can share the inner sidewall of the tray with the tray.

[0017] In such an embodiment, one or more partitions of the medical procedure package that separates the first and second sections from the third section further separates the second section from the first section. be able to. The second section-separated partition of one or more partitions can have a maximum height equal to the height of the tray, and the bottom of the second section can be lifted above the bottom of the tray. .. Alternatively, the second section-separated partition of one or more partitions can have a maximum height less than the height of the tray, and the bottom of the second section and the bottom of the tray are substantially. Are on the same plane.

[0018] In some embodiments, a catheter introduction package comprising a tray with instructions for the catheter introduction procedure imprinted directly on the tray is provided, at least some of the instructions of the catheter introduction procedure. It is exposed according to the process. The tray can include a first section, a second section, and a third section, and one or more partitions separate at least the third section from the first and second sections. The tray can further include a drainage system, a container containing a lubricant, a syringe of sterile liquid (eg, water, or, in some cases, saline), and a skin preparation kit. The first section can include at least a drainage system, which can include a Foley catheter, a drainage tube, and a drainage bag. The second section can include at least a container containing a lubricant. The first section can include a syringe of sterile liquid, such as sterile water, which can be configured to inflate the balloon of a Foley catheter with sterile water. According to certain embodiments, the water syringe can be connected to the expansion port of a Foley catheter during the manufacture of the assembly. Providing a pre-connected syringe to a Foley catheter can help minimize the number of steps required to introduce the catheter into the patient. The third section can include at least a skin preparation kit, which kit can include a disinfectant package and one or more swabs.

[0019] In such an embodiment, the catheter introduction package may further include a sample container and a label for the sample container. The third section can include a swab compartment, an overflow compartment, and a square storage compartment containing a sample container. Swab compartments can include wells and one or more grooves so that one or more grooves hold one or more swabs in one or more grooves by snap fit tabs, respectively. It is configured in. Overflow compartments can be fluid connected to the wells through one or more grooves, one or more grooves in which one or more swabs are removed from one or more grooves. It can be further configured to deliver the poured disinfectant to the wells. The disinfectant package can be placed above the swab compartment, overflow compartment, horn storage compartment, or a combination thereof.

[0020] In such an embodiment, the catheter introduction package provides a third section separation partition of one or more partitions at the well end of the swab compartment that separates the wells directly from the second section. Further can be included. Alternatively, the well end of the swab compartment can share the inner sidewall of the tray with the tray.

[0021] In such an embodiment, one or more partitions of the catheter introduction package that separates the third section from the first and second sections further separates the second section from the first section. be able to. The second section-separated partition of one or more partitions can have a maximum height equal to the height of the tray, and the bottom of the second section can be lifted above the bottom of the tray. .. Alternatively, the second section-separated partition of one or more partitions can have a maximum height less than the height of the tray, and the bottom of the second section and the bottom of the tray are substantially. Are on the same plane.

[0022] In such an embodiment, the catheter introduction package may further include a sterile wrap, pericare kit, band, and packaging label. The sterile wrap can be in a folded configuration around the tray. The pericare kit can be placed with the catheter introduction tray, but outside the sterile wrap. The band is on the outside of the sterile wrap and can hold the sterile wrap in a folded configuration around the catheter introduction tray. The band can also include instructions on how to orient the tray before opening the sterile wrap. The packaging label can be on the outside of the sterile wrap to identify the catheter introduction package. In addition, the packaging label can contain information that highlights the basic characteristics of the catheter introduction package in a quick and easy-to-read manner.

[0023] In some embodiments, the catheter introduction package comprises a catheter introduction tray. The catheter introduction tray comprises a first compartment for holding the drainage system, a second compartment for holding the syringe, and a third compartment for holding the swab. The swab is tilted so that the swab's absorbent head is deflected downward into the well of the third compartment and the elongated member of the swab is angled upward for easier grip and removal. Held in posture. The catheter introduction tray further comprises a catheter introduction instruction or procedure indication imprinted directly on the catheter introduction tray. This catheter introduction package may further include a sterile wrap (eg, CSR wrap) wrapped around the catheter introduction tray. The absorbent head of the swab may be formed from an absorbent foam and the elongated member of the swab may have a substantially rectangular cross section with rounded ridges. The catheter introduction package may further include a peri-care kit packaged with the catheter introduction tray in a location on the outside of the sterile wrap. This catheter introduction package may further include a belly band on the outside of the sterile wrap. The band provides instructions or procedural indications on how to orient the catheter introduction tray before opening the sterile wrap. In addition, the catheter introduction package may include a packaging label on the outside of the sterile wrap. The packaging label has at least three sides folded from the top portion of the label into different planes. These at least three sides are visible when the catheter introduction package is viewed from one or more sides of the catheter introduction package. Alternatively or additionally, the packaging label comprises an information structure (eg, an information square). Each of these superstructures emphasizes the basic features of the catheter introduction package in a manner that is quick and easy to read. This catheter introduction package may include a sealed outer container or outer bag (eg, a clear plastic bag) around other components to maintain sterility during transport and storage. ..

[0024] In some embodiments, the medical procedure package is directly engraved or included instructions on the medical procedure tray with three or more compartments holding instruments useful for performing the medical procedure. / It is a procedure display, and includes an instruction / procedure display that instructs the user how to carry out the process of the medical procedure. These three or more compartments, instructions / procedure indications and instruments of the medical procedure tray are arranged in a predetermined arrangement, in which the medical procedure is intuitive from process to process based on the arrangement. It is an aspect that progresses so that it can be understood. In this arrangement, various components or instruments (eg, 2 to 20 instruments / components or 4 to 10 instruments / components) are placed on each other in the order in which those components or instruments are used. Stacking on top may be included (eg, a component or device that should be used before the other component or device is positioned is placed on top of another component or device that will be used later. Ru).

[0025] In some embodiments, the method of treating a patient comprises the step of preparing a medical procedure tray. This medical procedure tray is a medical procedure tray with three or more compartments with instruments useful for performing medical procedures and instructions / procedure displays directly engraved on the medical procedure tray. It is equipped with an instruction / procedure display that instructs the user to implement the procedure. The method may further comprise the step of performing the medical procedure for the patient while following the instructions / procedure indications imprinted on the medical procedure tray. Three or more compartments of the medical procedure tray, instructions / procedure displays and instruments, intuitively understand the medical procedure from process to process based on how they are arranged on / within the medical procedure tray. It is arranged in such a way that it progresses as much as possible.

[0026] In some embodiments, the method of introducing a catheter into a patient comprises the step of preparing a catheter introduction package with a catheter introduction tray. The catheter introduction tray comprises a first compartment for holding a drainage system with a catheter and a second compartment for holding a swab. The swab holds the swab in an inclined position in which the swab's absorbent head is deflected downward into the wells of the second compartment and the elongated member of the swab is angled diagonally upward. In this method, the disinfectant is further poured into the well so that the absorbent head comes into contact with the disinfectant, the area where the patient's catheter should be introduced is washed with a swab, and a portion of the catheter is placed in the patient's urethra. It has a process of inserting. A sealed container or bag may be placed around the catheter introduction tray. The method may comprise the step of opening the sealed container or bag. A sterile wrap may be wrapped around the catheter introduction tray. This method may include the step of opening the sterile wrap before pouring the disinfectant into the wells. This catheter introduction package may further include a pericare kit located on the outside of the sterile wrap. The method may comprise cleaning a portion of the patient's perineum using a perineal kit prior to opening the sterile wrap. Bands may be placed on the outside of the sterile wrap. The band may be provided with instructions (s) / procedure indications (s) / procedures (s) on how to properly orient the catheter introduction tray before opening the sterile wrap. The method may comprise orienting the tray according to this instruction (s) / procedure indication (s) prior to opening the sterile wrap.

[0027] In some embodiments, the method of manufacturing a catheter introduction package comprises the step of preparing a catheter introduction tray. This catheter introduction tray is a third compartment having a first compartment, a second compartment, a third compartment, and a sloping portion at the bottom of the third compartment, which has a groove for holding a swab. It comprises a compartment and a catheter introduction instruction / procedure display stamped directly on the catheter introduction tray. The first, second and third partitions are each at least partially separated from each other by partitions. The method may comprise a step of placing the drainage system in the first compartment, placing the syringe in the second compartment, and placing the swab in the third compartment. The swab is such that the absorbent head of the swab is deflected downward into the well of the third compartment and the elongated member of the swab is angled diagonally upward for easier gripping and removal. Placed in a parcel. The method may further comprise a step of wrapping the catheter introduction tray in sterile wrap and a step of placing a band around a portion of the sterile wrap. The band provides instructions (s) / procedure indications (s) / procedures on how to properly orient the catheter introduction tray before opening the sterile wrap. In addition, the method may comprise adding a pericare kit to the catheter introduction tray on the outside of the band and sterile wrap. This pericare kit includes a cleansing towelette, a hand disinfectant, and a zippered bag that holds instructions / procedure instructions for cleaning the patient. The method may include the step of adding detailed catheter introduction instructions and / or procedural indication documents to the catheter introduction package. Further, this method is a step of placing a packaging label on a catheter-introduced package, which is a packaging label and has at least three side portions that are folded from a top surface portion, and / or a packaging label, which is quick. It comprises the step of placing the packaging label on the catheter introduction package with an information structure (s) that emphasizes one or more basic features of the catheter introduction package in an easy-to-read manner. May be good. This information structure (s) may be one information square or many information squares. The method may further comprise a step of sealing the clear plastic bag (eg, by heat sealing) surrounding the catheter introduction package.

[0028] In some embodiments, the catheter introduction system comprises a container that secures components for the catheter introduction procedure. The container has an outer shell that defines the overall 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 partitions include a first partition sized and configured to accommodate the catheter assembly, and one or more second partitions separated from the first partition by one or more partitions. It is equipped with. At least one of the one or more second compartments comprises at least one partial partition of the one or more partitions (eg, a partition with a low height portion).

[0029] In some embodiments, a catheter introduction system for performing a catheter introduction procedure is provided. This catheter introduction system is equipped with a catheter introduction tray. The catheter introduction tray has an outer shell that defines the overall shape of the container and multiple compartments within the outer shell. Each of the plurality of partitions is separated from one or more adjacent partitions among the plurality of partitions by one or more partitions. The plurality of partitions may comprise a first compartment that houses the catheter assembly and one or more second compartments that are separated from the first compartment by one or more partitions. At least one of the one or more second compartments may include at least one partial partition of the one or more partitions (eg, a partition with a lower height portion). In addition, the catheter introduction system comprises one or more swabs located within the second compartment of the one or more second compartments.

[0030] Embodiments of the disclosed packages, trays, devices, systems and methods and improvements thereof can be more fully understood by reference to the drawings below. Each part of the content of this patent document is subject to copyright protection under copyright law in the United States and other countries. The Patent Document or the Patent Disclosure appears in a file or record made available to the United States Patent and Trademark Office, and the owner of this copyright may refer to the Patent Document or the facsimile copy of the Patent Disclosure. I do not object to any person, but I own all the copyrights.

[0031] Top view of a medical procedure tray in the form of a catheter introduction tray with an integrated instruction / procedure display. [0032] Top, front (ie, proximal), right perspective view of the medical procedure tray of FIG. 1. [0033] FIG. 1 is a right elevation view of the medical procedure tray of FIG. [0034] is a back (ie, distal) side elevation view of the medical procedure tray of FIG. [0035] Top view of another medical procedure tray in the form of a catheter introduction tray larger than the tray of FIG. 1 with an integrated instruction / procedure display. [0036] Top view of a swab or swab stick that may be included in a catheter introduction package and / or a catheter introduction tray. [0037] FIG. 6A is a side perspective view of the swab or swab stick. [0038] FIG. 6A is an end view of the swab or swab stick of FIG. 6A showing the cross-sectional shape of an elongated member or rod. [0039] Top view of a swab or swab stick that may be included in a catheter introduction package and / or a catheter introduction tray. [0040] FIG. 7A is a side perspective view of the swab or swab stick of FIG. 7A. [0041] It is an end view of the swab or the swab stick of FIG. 7A showing a cross-sectional shape different from the cross-sectional shape shown in FIG. 6C of an elongated member or rod. [0042] Top view of a swab compartment and a small storage or overflow compartment of a catheter introduction tray with a swab or swab stick similar to the swab or swab stick shown in FIGS. 7A-7C, in this figure the swab compartment. One swab or swab stick is rotated about 90 degrees to release it from the fixation structure. [0043] Top view of a catheter introduction package enclosed in a sealed bag and having a packaging label, the packaging label having information squares on its top surface and two sides, these sides of which are catheters. The introductory package is easily visible even when stacked with other catheter introductory packages. [0044] A top front perspective view of another catheter introduction package enclosed in a sealed bag and having a packaging label (different from the catheter introduction package shown in FIG. 9), wherein the packaging label is the top surface and It has information squares on two sides (one of which is visible), which are easily visible even if the catheter introduction package is stacked with another catheter introduction package. Is. [0045] Top view of the catheter introduction package of FIG. 9, which is taken out of the sealed bag but still has the same packaging label on it. [0046] Provided with additional lines to indicate the position where the sides can be bent when placed on top of other components of the catheter introduction package prior to enclosing the catheter introduction package in the sealed bag. FIG. 10 is a flattened top view of the packaging label of the catheter introduction package of FIG. Catheter introduction package after removal of sealed bag and packaging label (eg, catheter introduction of FIG. 9 or FIG. 10) showing detailed instruction / procedure display document or instructions for use (DFU) document on it. It is a top view of the package). [0048] A page of a detailed catheter introduction / procedure display document or a usage instruction (DFU) document that may be provided in a catheter introduction package is shown. [0049] FIG. 14A shows another page of the detailed catheter introduction instructions / procedure display or usage instructions (DFU) document. [0050] Shows another page of the detailed catheter introduction instructions / procedure display or usage instructions (DFU) document of FIG. 14A. [0051] Shows another page of the detailed catheter introduction instructions / procedure display or usage instructions (DFU) document of FIG. 14A. [0052] Shown is the front of a patient education information sheet / pamphlet that may be included in the catheter introduction package. [0053] The back side of the patient education information sheet / pamphlet of FIG. 15A is shown. [0054] Top view of the catheter introduction package of FIG. 13 without detailed instruction / procedure display documents or usage instructions (DFU) documents, showing a label or insert sheet on it. [0055] Top view of a catheter introduction package without a label or insert sheet (eg, similar to the catheter introduction package of FIG. 16) showing a perineal care or perineal care kit / packet on it. [0056] Top view of a catheter introduction package without a label or insert sheet (eg, similar to the catheter introduction package of FIG. 16) showing another different perineal care or perineal care kit / packet on it. [0057] FIG. 18 is an isolated view of the perineal care (ie, perineal care) kit or packet component of FIG. Top view of a perineal care (ie perineal care) kit or packet-free (eg, similar to the catheter introduction package of FIG. 17 or FIG. 18) catheter introduction package, showing a band with instructions / procedure indications on it. Is. Top view of a bandless (eg, similar to the catheter introduction package of FIG. 20 or FIG. 21) showing a sterile wrap that is only partially folded / wrapped around the catheter introduction tray. Is. [0060] Top view of the catheter introduction package of FIG. 22 with a sterile wrap that is fully unfolded but still laid under the catheter introduction tray, before or during production of components. / Shows the contents of the catheter introduction tray after all the components to be contained in the sterile wrap have been placed in the wrap during packaging. [0061] Top view of the catheter introduction package of FIG. 23 with a package of sterile gloves that is partially unfolded and rests on a catheter introduction tray. [0062] Top view of the catheter introduction package of FIG. 24 without a package of sterile gloves, with exposed pads / drapes (representing waterproof underpads and / or windowed drapes) resting on the catheter introduction tray. .. [0063] The catheter introduction package of FIG. 25 with a pad / drape moved from the swab compartment, which exposes a packet of sterile povidone iodine solution that is in the swab compartment and extends over a small storage or overflow compartment of the catheter introduction tray. It is a top view of. Top view of the catheter introduction package of FIG. 26 without povidone iodine solution, with the swab or swab stick exposed in the swab compartment with the proximal end of the rod extending over the small storage or overflow compartment of the catheter introduction tray. Is. [0065] Top view of the catheter introduction package of FIG. 27, in which a syringe of sterile fluid is attached to the inflatable port of the catheter. [0066] The distal portion of the catheter is placed within the syringe or catheter compartment, and the syringe of lubricating jelly is placed adjacent to the syringe or catheter compartment and over the distal region or distal end of the catheter. FIG. 28 is a top view of the catheter introduction package of FIG. 28, ready to be dispensed. [0067] Top view of the catheter introduction package of FIG. 29 after the catheter has been removed from the tray and inserted into the patient, with the drainage tube extending towards the patient. [0068] It is a top view of the catheter introduction system. [0069] Top view of the catheter introduction tray of the catheter introduction system of FIG. 30A, wrapped in wrap. [0070] Isometric view of the catheter introduction tray and its contents. It is an isometric view of the catheter introduction tray of FIG. 31A from which a part of the contents is taken out. [0072] FIG. 31A is a back isometric view of the catheter introduction tray. [0073] It is a top view of the catheter introduction tray of FIG. 31A from which all the contents were taken out. [0074] Top view of the catheter introduction system. [0075] It is a top view of a windowed drape. [0076] Isometric view of the swab. [0077] Isometric view of the catheter introduction system. [0078] FIG. 36A is an isometric view of the catheter introduction tray of the catheter introduction system of FIG. 36A. [0079] It is an isometric view of a catheter introduction system. [0080] FIG. 37A is an isometric view of a partially expanded catheter introduction tray of the catheter introduction system of FIG. 37A. FIG. 37A is a partial isometric view of the expanded catheter introduction tray of the catheter introduction system of FIG. 37A. [0082] FIG. 6 is a diagram of another medical procedure tray with some embodiments. [0083] Another diagram of the medical procedure tray of FIG. 38A. [0084] Another view of the medical procedure tray of FIG. 38A with a cover. [0085] Another view of the medical procedure tray of FIG. 38A with a cover. [0086] FIG. 3 is a diagram of another medical procedure tray with some embodiments. [0087] Another view of the medical procedure tray of FIG. 39A. [0088] FIG. 3 is a diagram of a medical procedure tray comprising a plurality of retainers in a first configuration, according to some embodiments. [0089] FIG. 6 is a diagram of a medical procedure tray comprising a plurality of retainers in a second configuration, according to some embodiments. [0090] FIG. 3 is a diagram of another medical procedure tray with some embodiments. [0091] Another diagram of the medical procedure tray of FIG. 40A. [0092] FIG. 3 is a diagram of another medical procedure tray with some embodiments. [0093] Another diagram of the medical procedure tray of FIG. 41A. [0094] Another view of the medical procedure tray of FIG. 41A. [0095] FIG. 3 is a diagram of another medical procedure tray with some embodiments. [0096] Another view of the medical procedure tray of FIG. 42A. It is another figure of the medical procedure tray of FIG. 42A. [0097] FIG. 3 is a diagram of another medical procedure tray with some embodiments. FIG. 5 is a view of a removable retainer on a partition or side of a medical procedure tray according to some embodiments. [0099] Another illustration of a removable retainer on a partition or side of a medical procedure tray with hidden tabs for instructions, according to some embodiments. [0100] Another illustration of a removable retainer on a partition or side of a medical procedure tray with exposed tabs for instructions, according to some embodiments. [0101] Illustration of an accessory type retainer on the side of a medical procedure tray according to some embodiments.

[0102] Although the invention may accept various modifications and alternatives, the drawings show specific embodiments of the invention as examples, which are described in detail herein. To. However, the description of a particular embodiment herein is not intended to limit the invention to the particular embodiments disclosed, and is within the spirit and scope of the invention as defined by the appended claims. It should be understood that it is intended to include all modifications, equivalents and alternative embodiments in.

[0103] The following description and attachments illustrating and illustrating some embodiments are medical procedure packages, medical procedure trays, catheter introduction packages, catheter introduction trays, and these based on various aspects and features of the present disclosure. It is intended to illustrate, in a non-limiting manner, the components, assemblies, systems, etc. associated with, as well as some possible configurations of the various methods and methods of using them.

[0104] This specification describes various packages, kits, trays, systems, assemblies, devices and methods, including those used in various medical procedures (including, for example, catheter introduction procedures). Hereinafter, specific embodiments will be described as examples, but the embodiments and examples described are not limited to the present invention. Thus, for example, aspects of the invention relating to a catheter introduction package, a catheter introduction tray, a catheter introduction procedure, etc. may be described, while disclosures are made to packages, trays, systems / assemblies, procedures, etc. relating to catheter introduction. Not limited. Rather, the principles of the invention related to the embodiments described herein can also be applied to other embodiments and other types of packages, trays, systems / assemblies, devices, methods and the like.

[0105] According to various embodiments, the above-mentioned objectives and the objectives described elsewhere herein are, for example, more intuitive layouts or better organized layouts, trays. This can be achieved by providing an improved medical procedure package or kit that includes a medical procedure tray with instructions / procedure indications, etc. provided above. For example, an improved catheter introduction package or kit may be provided to achieve goals such as improving ease of use, improving adherence to proper procedures, reducing the likelihood of infection, and the like.

[0106] According to various embodiments, the medical procedure package may include a medical procedure tray therein. The medical procedure package may further include other components necessary or useful for the medical procedure. The medical procedure trays considered herein (s) may be single-stage trays or may have multiple stages. This medical procedure tray (s) may have a variety of shapes and sizes. For example, the medical procedure tray may have an overall or generally rectangular, square, circular, oval, triangular, hexagonal, polygonal or other shape. As a non-limiting example, a substantially rectangular medical procedure tray has a length ranging from 177.8 mm (7 inches) to 508.0 mm (20 inches), 101.6 mm (4 inches) to 304.8 mm (12 inches). ), And may have a height in the range of 25.4 mm (1 inch) to 101.6 mm (4 inches). In one embodiment, a substantially rectangular medical procedure tray (eg, a catheter introduction tray similar to the catheter introduction tray shown in FIGS. 1-4) is about 279.4 mm (about 11 inches) long and about 215. It may have a width of 9 mm (about 8.5 inches) and a height of about 50.8 mm (about 2 inches). In one embodiment, a substantially rectangular medical procedure tray (eg, similar to the tray shown in FIGS. 5, 31A-31C, 32) is about 355.6 mm (about 14 inches) long and about 215.9 mm (eg, similar to the tray shown in FIGS. 5, 31A-31C, 32). It may have a width of about 8.5 inches) and a height of about 63.5 mm (about 2.5 inches).

[0107] The medical procedure tray can also include multiple sections with different shapes and sizes, any of which sections can optionally form a compartment. Sections of the medical procedure tray can be designated for one or more specific uses (eg, wells for iodine, sections for storage, etc.), while compartments can be one or more. Physical features such as partitions can be at least partially and completely separated from one or more other sections, partitions, or combinations thereof. The partition can be formed from the medical procedure tray itself (eg, formed during the injection molding process), and the opposite faces of the partition are other sections or compartments with a higher or lower height bottom. When separating the compartments from, the heights can be unequal. The partitions can be formed separately from the same material as the medical procedure tray or from a different material than the medical procedure tray. The partition is also from any one or more of the other components necessary or useful for the medical procedure until any one or more of the other components are removed from the medical procedure tray. It can be formed temporarily. For example, with respect to components necessary or useful for catheter introduction, is one or more partitions required for the specimen or sample container, instruction / procedure display, or catheter introduction as described herein? Alternatively, it can be temporarily formed from other useful components. Similar to sections, compartments can have different shapes and sizes (eg, compartments can be any of the shapes described for the medical procedure tray itself, or any other shape. ).

[0108] According to various embodiments, the medical procedure package may be a catheter introduction package comprising one or more catheter introduction trays therein. For example, the catheter introduction package may include an improved catheter introduction tray with a more intuitive or better organized layout and / or instructions / procedure indications on the tray. Various features of the catheter introduction package and / or catheter introduction tray are described below, but those characteristics described are included in the medical procedure package and / or tray used for procedures other than catheter introduction. Or it can be applied.

[0109] The catheter introduction package may include components necessary or useful for catheter introduction. Included in the catheter introduction package are drainage systems, drainage / collection bags, drainage tubes, catheters (eg, Foley catheters), drainage outlets, stabilizing devices (eg, CRBard, Inc.). StatLock® Foley Stabilization Device), urine meter, swab or swab stick, preparation sphere (eg, defatted cotton ball), forceps, specimen or sample container, fill in details about the sample, specimen or sample Labels that can be affixed to the container, a packet or container of disinfectant skin cleaner (eg, a packet or container of povidone iodine solution), a packet or container of lubricant (eg, a syringe of lubricating jelly), a syringe of sterile fluid (eg, a syringe of lubricating jelly). , 10cc injector of sterile water to inflate the holding balloon of the Foley catheter), windowed drape on the patient, underpad under the patient's butt (eg, waterproof absorbent underpad), gloves (eg, rubber) Gloves, latex gloves, latex-free glove packages), sterile wraps (eg CSR wraps), bands (eg to keep sterile wraps in a folded shape), shade care packets, hand sterilizers (eg) , Disinfectant hand rinse gel), wet taollet (eg, package of castile soap taolet), instructions / procedure display (eg, instruction sheet for health care providers, and / or instruction brochure for patients), safety considerations It may include items / process checklists, patient information catheters, insert sheets, packaging labels, outer containers (eg, sealed bags), and / or other components. These components included in the catheter introduction package may be placed in a separate package or bag (eg, the outer package of the tray) and provided in one or more compartments of the catheter introduction tray, or a second. It may be provided in the catheter introduction tray of.

[0110] The catheter introduction tray (s) may be labeled with process sequence instructions / procedure indications located logically on the tray (s). The catheter introduction tray (s) may have a layout and configuration that allows a more intuitive understanding of the catheter introduction procedure. Single-stage catheter introduction trays are shown, for example, in FIGS. 1-4 and are described below. This single-stage catheter introduction tray has a substantially rectangular shape and has a large number of compartments of various shapes. This large number of compartments are equipped with process order instructions / procedure displays and also have an improved layout. Similarly, other similar single-stage catheter introduction trays are shown in FIGS. 5,31A-31C, 32.

[0111] According to various embodiments, for example, as shown in FIGS. 1-5, the catheter introduction tray has a main compartment 1, a syringe or catheter compartment 2, a swab compartment 3, and a small storage or overflow. A compartment 4 and a square storage compartment 5 may be provided. The tray is further equipped with reinforced ribs (eg, reinforced ribs 20 shown in FIG. 2, see also reinforced ribs 205 in FIGS. 31A-31C). Reinforcing ribs help to reinforce the tray and also help prevent the tray from bending when held (eg, when held with one hand).

[0112] With reference to FIGS. 1, 2 and 5, main compartment 1 is the largest compartment in the tray and any number of items for the catheter introduction procedure (eg, drainage system, collection bag, drape, under). Can accommodate pads, inflatable syringes and / or gloves). The drainage system that may be included in the catheter introduction package and / or main compartment 1 is, for example, a drainage / collection bag, a drainage tube, a catheter (eg, a Foley catheter), a drainage outlet, a urine meter and / or other drainage system configuration. It may have an element. These drainage system components may be pre-connected and pre-connected and housed in a catheter introduction package, or may be housed as separate components that will be assembled / connected later.

[0113] The drainage system and tube included in the catheter introduction package may be configured and arranged in a manner that helps improve drainage of urine through the system and tube. For example, the drainage system tube or other component may be configured to cut off the surface tension of the fluid in order to improve drainage. The drainage tube can be shortened to accommodate lower floor beds, or the length of the drainage tube can be adjusted to accommodate beds of various sizes. The tube or other drainage system component may have a coating (eg, a lubricating coating) on the surface to facilitate drainage through it. Optionally, the tube or other drainage system component may have a superhydrophobic pattern on the surface to facilitate drainage.

[0114] In addition, the durometer of the tube or other drainage system component has a suitable range. However, for components that can be coiled and placed in trays (eg, drainage tubes and / or catheters), it is desirable to have a tube durometer that does not tend to retain its solid shape at room temperature. For example, a durometer that is ultimately used for a coiled component does not have a tendency to leave that component in a coiled shape when removed from the tray and put into use. Can be experimented with various durometers to ensure. To facilitate drainage, for example, the drainage tube may be coiled when connected to a patient, even though it is placed in the main compartment in a coiled state. It is desirable to give the drainage tube a durometer so that it does not maintain and tends to straighten the drainage tube. The drainage tube may be made of polyvinyl chloride (PVC), silicone, latex, Teflon or other polymeric material.

[0115] As shown in FIG. 1, the sides 8 and 9 of the tray form two orthogonal inner walls of the main compartment 1 and form the corners of the main compartment 1. At the corners, the sides 8 and 9 intersect each other. Two additional internal partitions 10, 12 separate the main partition 1 from the other partitions. The two internal partitions 10, 12 include low-height portions 14, 16 (lower than the full-height tray partition, inner sidewall or side surface).

[0116] Further, the main compartment 1 is provided with an internal fillet 18 formed at a corner between the floor of the main compartment 1 and the inner wall surface of the main compartment 1. Such fillets 18 can reinforce the corners of the main compartment 1.

[0117] For example, as shown in FIGS. 1, 2 and 5, the tray main compartment may include integrated instruction / procedure indications and / or other information on the main compartment. For example, the main compartment may carry a logo or brand name (eg, "SureStep ^TM Foley Tray System" and "BARD") written on the main compartment. The main compartment further, or instead, comprises instructions / procedure indications related to catheter introduction, which are printed on the main compartment or otherwise contained on the main compartment. May be good. For example, the main compartment may include instructions / procedure indications on how to introduce the catheter to the patient, or instructions / procedure indications on the steps to be performed after catheter introduction. Optionally, the main compartment may be equipped with instructions / procedure indications for proper care and maintenance of the Foley catheter. For example, as shown in FIGS. 1 and 5, the integrated instruction / procedure display on the main compartment may include the following instruction / procedure display. "(1) Secure Foley with StatLock®", "(2) Place the bag below the bladder", "Clip the tube to the seat", "(3) Record the date of insertion "," (4) maintain the red seal according to hospital policy "," (5) assess the need for catheters on a daily basis ". These instructions / procedure indications or other information may be displayed in uppercase or bold to ensure visibility for the clinician to read the instructions / procedure indications or other information, as well as other information. You may be alerted by the method. Optionally, instructions / procedure displays are printed on the main compartment to remind the health care provider / clinician to instruct the patient on how to properly care for and maintain the catheter after catheter introduction. It may or may be provided. Instructions / procedure indications may be written to help the health care provider / clinician remember to cover important instructions to be given to the patient.

[0118] The syringe or catheter compartment 2 has an elongated shape and spans approximately the entire length of the tray. The tray partitions and inner sidewalls contribute to the formation of the syringe or catheter compartment 2. Partition 12 extends between the opposing inner sidewalls of the tray, separating the syringe or catheter compartment 2 from the other compartments (ie, from the main compartment 1 and the swab compartment 3). The syringe or catheter compartment 2 is sized and shaped to accommodate one or more syringes (eg, a syringe of lubricating jelly and a syringe of sterile fluid for inflating a holding balloon) and / or a catheter (eg, a Foley catheter). have. For example, a syringe of lubricating jelly and a syringe of 10 cc sterile water can be placed in the syringe or catheter compartment 2, but the end user (eg, a clinician) removes the syringe at the time of catheter introduction and catheters before inserting it into the patient. Can be placed within the syringe or catheter compartment 2 (eg, to facilitate catheter lubrication).

[0119] A portion of partition 12 separates catheter compartment 2 from main compartment 1. A portion of partition 12 has a full height (eg, extending to the same height as the sides of the tray), whereas partition 12 has a full height (partition 12, the inner wall of the tray or the full height of the sides). It also has low) low parts 16 and 22. The lower portion 16 of the partition 12 is a partition cut or opening, which allows the syringe or catheter compartment 2 to communicate fluidly with the main compartment 1 and also the main compartment 1 with the syringe or catheter compartment 2 and fluid. Can be communicated). Along the lower portion 16, the partition 12 is a small step between the syringe or catheter compartment 2 and the main compartment 1, as shown, for example, in FIGS. 2 and 6 (see also FIGS. 31A-31C). May be formed. This stage may be formed by a main compartment 1 having a lower / deeper floor than the syringe or catheter compartment 2 floor, for example as shown in FIGS. 2 and 6 (see also FIGS. 31A-31C).

[0120] In FIGS. 1 and 2, another low-height portion of the partition (ie, the low-height portion 22) separates the syringe or catheter compartment 2 from the swab compartment 3. The low height portion 22 of the partition 12 has a partial or low height relative to the full height of the inner sidewall or side surface of the tray. FIG. 5 shows an alternative arrangement of the low height portion 16, in which both of the low height portions 16 are located along the partition between the syringe or catheter compartment and the main compartment. (Ie, there is no low profile 22 between the syringe or catheter compartment and the swab compartment). Other arrangements and configurations are possible. If the syringe is placed or provided in the syringe or catheter compartment 2, the low height portions (eg, low height parts 16, 22) allow the end user to insert a finger into the tray and grab the syringe. By providing a more open space, it helps to facilitate easy removal of the syringe from the syringe or catheter compartment 2. This makes it easier to remove the syringe than if the partition 12 had no low profile and the clinician had to try to grab the syringe in a narrower area.

[0121] For example, as shown in FIGS. 1 and 5, the syringe or catheter compartment of the tray may further comprise an integrated instruction / procedure indication and / or other information on this compartment. For example, the syringe or catheter compartment may optionally include instructions / procedure indications related to catheter introduction written on this compartment. As shown in FIGS. 1 and 5, the integrated instruction / procedure display on the syringe or catheter compartment may comprise the following instruction / procedure display, "where dispense and lubricate the foley. "Masu" (or this instruction could simply be "lubricate Foley", "dispens Foley", or any other similar indication), "retract the genitals (non-dominant hand)", "Prepare the patient with a swab (dominant hand)", "Insert a catheter and inflate the balloon (dominant hand)". As shown in FIGS. 1 and 5, and as described above, these instructions / procedure indications determine which hand to use for a given process (eg, dominant or non-dominant). You can inform the management provider. These instructions / procedure indications or other information may be displayed in uppercase or bold to ensure visibility for the clinician to read the instructions / procedure indications or other information, otherwise. May be alerted at.

[0122] Note that the side of the catheter introduction tray may also be provided with instructions / procedure indications or other information on it. For example, as shown in FIGS. 1, 2 and 5, the side surface 6 may be provided with an instruction / procedure display 47 “Open iodine” and a side surface 7 may be provided with an instruction / procedure display 49 “water syringe”. It may be equipped with "I will install". These instructions / procedure indications or other information may be displayed in uppercase or bold to ensure visibility for the clinician to read the instructions / procedure indications or other information, otherwise. May be alerted at.

[0123] As shown in FIGS. 3 and 4, the base 55 of the syringe or catheter compartment 2 may be offset from the base of all other compartments. In other words, the depth or separation distance from the top of the tray to the base 55 of the syringe or catheter compartment 2 does not have to be the same as the depth or separation distance from the top of the tray to, for example, the base 57 of the main compartment 1. Since the base 55 is offset from the base of the other compartment, the bottom / floor of the syringe or catheter compartment is also offset from the bottom / floor of the other compartment, which is from the bottom / floor of the main compartment 1. It also includes being offset.

[0124] The swab compartment 3 extends along a portion of the inner side wall of the tray along the side surface 6 of the tray, which portion of the inner wall surface forms the side surface of the swab compartment 3. Swab compartment 3 may include various items, such as swabs or swab sticks and iodine (eg, iodine fore such as povidone iodine, tincture of iodine, water soluble iodine, etc.) and one or more disinfectants. A portion of partition 10 and a portion of partition 12 extend along the other two sides of the swab compartment 3 to form the other two sides of the swab compartment 3, and the swab compartment 3 is the main. Separated from partition 1 and syringe or catheter compartment 2, respectively. In addition, a small storage or overflow compartment 4 extends along the fourth aspect of the swab compartment 3. In one embodiment, partition 10 has a full height that separates the swab compartment 3 from the main compartment 1, for example, as shown in FIGS. It has a lower height (ie, the lower height portion 22) that separates from the catheter compartment 2. In one embodiment, partitions 10 and 12, regardless of whether the swab compartment 3 is separated from the main compartment 1 and the syringe or catheter compartment 2, with the inner wall 10 and the inner wall 12, for example, as shown in FIG. Both have full height.

[0125] Swab compartment 3 has an oblique bottom / floor that extends between the small storage or overflow compartment 4 and the syringe or catheter compartment 2 and points downward between those compartments. (Ie, the bottom / floor of the swab compartment 3 near the catheter compartment 2 is lower than near the storage compartment 4). Therefore, the fluid poured into the swab compartment flows in the direction toward the catheter compartment 2 and is near the partition 12 that separates the swab compartment 3 from the catheter compartment 2 (for example, the low height portion 22 in FIGS. 1 and 2). It can accumulate in the lowest / deepest part of the swab compartment (adjacent to), i.e. well 24. For example, as shown in FIGS. 1 and 2, the corner portion of the swab compartment 3 may be provided with a fillet similar to the fillet 18 of the main compartment 1.

[0126] FIG. 8 shows an enlarged view of the swab compartment 3 and the adjacent small storage or overflow compartment 4, in which the swab or swab stick is housed. Near the small storage or overflow compartment 4, the bottom / floor of the swab compartment 3 may be supported by another partition 30 (shown in FIG. 2) that separates the small storage or overflow compartment 4 from the swab compartment 3. .. Further, the partition 30 may extend upward (from the bottom / floor of the small storage or overflow compartment 4), but extends only to the bottom / floor of the swab compartment 3 and is either small storage or. The bottom / floor of the swab compartment 3 near the overflow compartment 4 remains unobstructed (so swabs or swab sticks with longer rods / stems, for example, as shown in FIG. 8). It may extend from the bottom / floor of the swab compartment 3 onto a portion of the small storage or overflow compartment 4). This configuration or arrangement further allows the small storage or overflow compartment 4 to act as an overflow if too much fluid / iodine is poured into the swab compartment 3.

[0127] Swab compartment 3 comprises one or more grooves 28 extending at least partially along the area between the small storage or overflow compartment 4 and the well 24 located at the bottom / floor of the swab compartment 3. ing. On the side of the swab compartment 3 near the catheter compartment 2, the groove 28 extends to the lowest / deepest portion 24 of the well 24 adjacent to the partition 12 and also has fluid communication with that portion. As a result, the liquid poured into the groove (s) 28 flows downward through the groove (s) 28 along a downward gradient and collects in the lowest / deepest part near the well 24. .. The groove (s) 28 may be configured to hold an elongated device (eg, swab or swab stick), and each of the grooves 28 may have a plurality of elongated devices (eg, swabs or swab sticks). It may be separated by one or more barriers 26 to help separate. The groove (s) 28 can further help secure the elongated device (eg, swab, swabbing stick, swab stick) within the groove (s) 28, an undercut or snap-fit structure. 32 (eg, snap-fit tabs) may be provided.

[0128] For example, as shown in FIGS. 1, 5 and 8, the tray swab compartment may further comprise an integrated instruction / procedure display and / or other information on it. For example, the swab compartment may optionally (eg, on one of the barriers 26) be printed on the swab compartment or otherwise provided with instructions / procedure indications related to catheter introduction. May be. As shown in FIGS. 1, 5 and 8, the integrated instruction / procedure display on the swab compartment may include the instruction / procedure display "Pour iodine here". These instructions / procedure indications or other information may be displayed in uppercase or bold to ensure visibility for the clinician to read the instructions / procedure indications or other information, as well as other information. You may be alerted by the method.

[0129] One or more swabs or swab sticks (eg, swabs or swab sticks 34 shown in FIGS. 6A-8) are placed in the swab compartment 3 and grooved (eg, as shown in FIG. 8). Can be kept within 28. The swab or swab stick may be specifically configured to fit snugly within the swab compartment 3 and be retained within the groove 28. The swab compartment 3 may further comprise an iodine or povidone iodine solution. The iodine or povidone iodine solution may be placed in its own container, packet or syringe (eg, the povidone iodine packet 52 shown in FIG. 26) within the swab compartment 3. Alternatively, the iodine or povidone iodine solution may be contained and / or encapsulated in the swab compartment 3 in direct contact with the swab (s) or swab stick (s) 34 (eg, in the swab compartment 3). It may be housed / enclosed in contact with the bottom / part of the floor.

[0130] FIGS. 6A-6C show an embodiment of a swab or swab stick 34 having an elongated member or rod / stem 38. This elongated member or rod / stem 38 has a rounded side surface (eg, in cross section) than the swab or swab stick 34 shown in FIGS. 7A-7C. 7A-7C show an embodiment of a swab or swab stick 34 having an elongated member or rod / stem 38. This elongated member or rod / stem 38 has sides that are not as round or angular as the swab or swab stick 34 shown in FIGS. 6A-6C. The swabs or swab sticks 34 shown in FIGS. 6A-7C represent other possible swabs or swab sticks that can be provided. The swab or swab stick 34 comprises an absorbent head 36 and an elongated member or rod / stem 38. The absorbent head 36 is configured to allow higher saturation in the wash solution (eg, iodine or povidone iodine solution) and greater contact with the surface area of the area to be washed. The absorbent head 36 can be formed from a variety of materials such as foam, rayon (eg, rayon puffs or rayon spirals), cotton, other materials, and / or these. Includes a combination of one or more of the materials of. In order to improve the saturation of the absorbent head, it is desirable that the absorbent head 36 is made of a material that easily absorbs and disperses the cleaning solution. For use in absorbent heads, a material that absorbs a sufficient weight percentage of the material in the cleaning solution is desirable, especially if the material further releases a large percentage of the absorbed cleaning solution. That is, it is desirable to use a material that absorbs a large amount of cleaning solution and also releases a large amount of cleaning solution when used for the patient for cleaning. It was found that forming the foam absorbent head 36 (as opposed to rayon or other materials) yields an absorbent head 36 with improved absorbency and saturation of the wash solution. In addition, the foam's absorbent head easily releases large amounts of cleaning solution when in contact with the patient's area to be cleaned and when pressed against the area being cleaned and slightly compressed. .. This makes it easier to clean the patient's area and allows the end user to clean the patient more gently. When the absorbent head 36 is made entirely or partially of foam, the foam is open cell foam, closed cell foam, polyurethane foam, high density foam, latex foam, honey gold. (Honey gold) Can be foam or other type of foam. The absorbent head may be heated to adhere to an elongated member or rod (eg, the foam may be heated and adhered to the rod), or other adhesive means may be used (eg, adhesive). May be used).

[0131] The foam or other material (s) selected for the absorbent head preferably does not deteriorate when in contact with the cleaning solution, or at least resists deterioration. In one embodiment, the swab or swab stick may be housed in contact with iodine or povidone iodine solution, so that the swab or swab stick is already saturated when first accessed within the catheter introduction package. There is. For example, a seal that keeps the wash solution in contact with the swab (s) or swab stick (s) absorbent heads (s) is placed in the swab compartment 3 or on top of the swab compartment 3. Leakage may be prevented until the seal is removed. It is extremely important that the absorbent head does not deteriorate over time when packaged and stored in contact with the cleaning solution. For example, the honey gold foam has sufficient resistance to deterioration when in contact with iodine or a povidone iodine solution.

[0132] The absorbent head 36 can have various sizes and shapes. The foam is preferably formed in a shape that provides greater contact with the surface area of the area to be cleaned. For example, the absorbent head 36 has a distal or distal region (eg, a region that comes into contact with the patient) that is less likely to come into contact with the patient (eg, a proximal end, or a absorbent head 36). May be formed in a shape substantially larger than the elongated member or the area attached to the rod 38). Thereby, the surface area of the end of the absorbent head in contact with the patient is increased, and the patient can be washed more quickly and easily. In addition, if the distal region of the absorbent head is larger, most of the iodine will be absorbed into the region of contact with the patient (conversely, the largest region of the absorbent head will be at the distal or distal end. When not nearby, much of the iodine is absorbed and wasted where it does not come into contact with the patient or wash the patient). The absorbent head 36 may be formed in a shape as shown in FIGS. 6A to 7B, and may have a width larger than the thickness. The absorbent head 36 may be formed entirely or generally circularly, rectangularly or trapezoidally. Optionally, the shape of the absorbent head 36 may be overall or generally conical, pyramidal, teardrop, oval or triangular (larger base end is swab or distal tip of swab stick). It may be arranged in), or it may have another shape. When the shape is a substantially pyramidal shape, the bottom surface of the pyramid shape may have a shape such as a substantially triangular shape, a square shape, a pentagonal shape, or a hexagonal shape. The ridge at the distal end of the absorbent head, whether substantially conical, pyramidal or other shape, is curved or tapered (eg, as the distal ridge is curved in FIGS. 6A-7B). It may be in the form. Further, the distal end of the elongated member or rod 38 may be curved (eg, the distal end may be semi-circular rather than flattening the apical or most distal end). The curvature is less likely to hurt the patient when cleaning with a swab or swab stick.

[0133] In one embodiment, the length of the absorbent head is between 12.7 mm (0.5 inch) and 50.8 mm (2 inch) (in one embodiment, this length is about 25.4 mm (). It may be (about 1 inch)), and the width of the absorbent head, at its widest point, is between 12.7 mm (0.5 inch) and 50.8 mm (2 inch) (one implementation). In the form, the width may be about 25.4 mm (about 1 inch) at its widest point), and the width of the absorbent head may be 2.5 mm (0) at its narrowest point. It can be between (1 inch) and 25.4 mm (1 inch) (in one embodiment, its width may be about 12.7 mm (about 1/2 inch) at its narrowest point). good. In addition, if the shape of the absorbent head is neither substantially conical nor substantially pyramidal (ie, the width and thickness of the absorbent head are the same everywhere), the absorbent head is less than the width (eg, the width). , May have a thickness between 2.5 mm (0.1 inch) and 25.4 mm (1 inch) (in one embodiment, this thickness is about 9.5 mm (about 3/8 inch). ) May be).

[0134] In one embodiment, the length of the elongated member or rod 38 may be between 50.8 mm (2 inches) and 177.8 mm (7 inches) (eg, the length of the elongated member or rod 38). It may be between 88.9 mm (3.5 inches) and 114.3 mm (4.5 inches), or it may be about 108.0 mm (about 4.25 inches)). The penetration length of the rod 38 into the absorbent head 36 (ie, the length of the rod 38 extending distally beyond the proximal end of the absorbent head) is 6.4 mm (0.25 inch). It may be between 25.4 mm (1 inch). It is preferable to ensure that this penetration length is within an appropriate range with respect to the overall length of the absorbent head. If the rod 38 gets too far into the absorbent head 36, the rod 38 can damage the patient's skin too easily (eg, the rod is more likely to rub the patient during washing). It can be high and the rod may not be surrounded by a sufficient amount of foam). On the other hand, if the rod 38 does not extend sufficiently into the absorbent head 36, the absorbent head 36 lacks structure and will rattle (especially if saturated with liquid). This makes it more difficult for the end user to guide the swab or swab stick's absorbent head and effectively clean the patient. Ideally, the penetration length of the rod 38 would be between 35 and 70% of the length of the absorbent head 36 (eg, the penetration length is about 50% of the length of the absorbent head). May be there). The elongated member or rod 38 can be formed from a variety of materials, including plastic or polymer materials.

[0135] The elongated member or rod 38 may have different cross-sectional sizes and shapes. For example, the swab or swab stick may be relatively flattened, or may have a substantially rectangular cross section (or, eg, a rectangular cross section with rounded edges as shown in FIG. 6C, or, eg, FIG. 7C). It may have a rectangular cross section with the ridges cut off so that it is easier to hold. The elongated member or rod 38 shown in FIGS. 6A-6C has a rounded ridge, but otherwise has a generally rectangular shape. This shape is easier to hold and operate while cleaning the patient than a rod with a circular cross section. In addition, this cross-sectional shape and similar cross-sectional shape of the elongated member or rod 38 allows the swab or swab stick to snap into the tray to prevent the swab or swab stick from moving during transportation or use. , Or allows it to be held under structure 32. To remove a swab or swab stick having this cross section, the elongated member or rod 38 may simply be twisted clockwise or counterclockwise, and the structure 32 facilitates the swab or swab stick to be used. release. For example, FIG. 8 shows two swabs or swab sticks snap-fitted or held in place under structure 32, in addition that structure 32 no longer holds or swab sticks. Shows one swab or swab stick twisted so as not to interfere with its removal. This not only makes the swab or swab stick very stable in the swab compartment 3 during transport and prior to use, but also makes the swab or swab stick removal very simple and easy at the time of catheter introduction.

[0136] In one embodiment, if the elongated member or rod has a substantially flat (eg, substantially rectangular) shape, the width or diameter of the elongated member or rod 38 is about 3.2 mm (about 1/8 inch). ) To about 19.1 mm (about 3/4 inch) (eg, this width may be about 6.4 mm (about 1/4 inch)) and the thickness is 1.6 mm. It may be between (1/16 inch) and 12.7 mm (1/2 inch) (eg, this thickness may be about 3.2 mm (about 1/8 inch)). If the elongated member or rod has a substantially circular cross section or is substantially cylindrical, the elongated member or rod 38 has a diameter of 3.2 mm (1/8 inch) to 12.7 mm (1/2 inch). ) (For example, this diameter may be about 6.4 mm (about 1/4 inch)).

[0137] The swab or swab stick is such that the swab or swab stick is exposed to the lowest / deepest portion of the bottom of the swab compartment 3, ie, iodine accumulated in the well 24, and is easily saturated with the iodine or povidone iodine solution. The absorbent head 36 is mounted and held in the tray in such a manner that it is in the lowest / deepest portion of the bottom of the swab compartment 3, ie in the well 24. However, the elongated member or rod 38 may be mounted and held in the tray in such a manner that it is not itself exposed to iodine or povidone iodine solution.

[0138] The small storage or overflow compartment 4 extends along a portion of the side surface 6 of the tray, which portion forms the inner sidewall of the tray and the sides of the small storage or overflow compartment 4. The other three sides of the small storage or overflow compartment 4 are formed by partial height partitions that separate the small storage or overflow compartment 4 from the main compartment 1, swab compartment 3 and corner compartment 5. These compartments may surround the small storage or overflow compartment 4 at its three sides. The small storage or overflow compartment 4 can serve as an overflow well that collects fluid that may overflow from the swab compartment. Optionally, the small storage or overflow compartment 4 can contain or retain one or more items useful for catheter introduction.

[0139] For example, as shown in FIGS. 1 and 5, the tray storage or overflow compartment may further comprise an integrated instruction / procedure display and / or other information on it. For example, the small storage or overflow compartment may optionally include instructions / procedure indications related to catheter introduction printed on this compartment or otherwise provided. Information integrated on small storage or overflow compartments, as shown in Figures 1 and 5, states that the health care provider / clinician should "see usage instructions for complete instructions." It may have a note. These instructions / procedure indications or other information may be displayed in uppercase or bold and otherwise to ensure visibility for the clinician to read the instructions / procedure indications or other information. You may be alerted.

[0140] The corner storage compartment 5 extends along a portion of the side surface 6 and a portion of the side surface 9 of the tray, and these portions form the sides and corners of the corner storage compartment 5. The other two sides of the corner storage compartment 5 are provided by a partial height partition (eg, a lower height portion 14) that separates the corner storage compartment 5 from the main compartment 1 and the small storage or overflow compartment 4. It may be formed. These compartments surround the corner storage compartment 5 at its two sides.

[0141] The bottom / floor of the corner storage compartment 5 may be non-planar. That is, the bottom / floor may have a non-planar shape, a round shape, or a partially cylindrical shape. This shape may be particularly useful for holding a sample or sample container. The corner storage compartment can accommodate or hold a variety of instruments useful for catheter introduction. For example, the corner storage compartment can hold a label, which can be filled in by the clinician on the first side and the second side can be affixed to the specimen or sample container. The second surface may already have an adhesive on it. The adhesive may be covered with a removable cover sheet, which can be removed when applying the label. The corner storage compartment may further comprise a sample or sample container 54.

[0142] In one embodiment, at least some of these compartments may be sealed in a manner that prevents contamination of the compartment. In one embodiment, at least one of these compartments may be opened independently of at least one other compartment. For example, the user may first open the main compartment while the other compartments are still sealed. After using the items contained in the main compartment, the user may open another compartment and use the items contained in that compartment.

[0143] 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 may pour iodine or other disinfectant into the swab compartment, the swab compartment may be used to impregnate the swab with the disinfectant, and then the iodine-impregnated swab may be used to wash the patient. .. The user may then open the syringe or catheter compartment 2 and dispense the lubricant into it before opening the main compartment 1. The user may then open the main compartment 1 to access the catheter. The shape and size of the catheter compartment facilitates lubrication of the catheter (eg, the tip of the catheter can rotate within the elongated shape of the catheter compartment, during which the lubricant can be collected on the surface of the catheter. can). The catheter may be lubricated within the syringe or catheter compartment 2 and then inserted into the patient's urethra.

[0144] According to various embodiments, as shown in FIGS. 1, 2, and 5, as described above, the tray provides an ordered process sequence instruction / procedure display for a suitable or preferred catheter insertion technique. You may have it on the tray.

[0145] Catheter introduction packages (s) and catheter introduction trays in the context of non-limiting procedures or methods using catheter introduction packages and catheter introduction trays, and in the context of methods of manufacturing or packaging catheter introduction packages. Other aspects (s) or features (s) are further described. The embodiments or features described below can be incorporated into the various embodiments described above. The placement of the components and how to access them is part of the intuitive overall design of the catheter introduction package. That is, the components and structures are arranged in a logical manner that proceeds from step to step, allowing the catheter introduction procedure to be more intuitively understood and completing the procedure more easily and / or quickly. The stepwise ordering of the components within the catheter introduction package helps the user / clinician to logically know which step will come next. For example, the second item, which is the next logical item to be used in the catheter introduction procedure, which was under the first item after exposing the first item in the package and then after the first item was used. Exposing the item. After the second item has been used, the third item, which is the next logical item to be used in the catheter introduction procedure under the second item, can be exposed and operated in the same manner. Can be done.

[0146] The catheter introduction package (s) and catheter introduction trays (s) described herein can be used in many different embodiments. The following describes non-limiting usage. However, depending on the circumstances and the needs of the patient's specific needs, the clinician may modify the steps or procedures described herein, or may rearrange the order of the steps, other than those described. Additional steps may be performed and / or certain steps may be omitted. The following description can also be thought of as a description of the entire procedure with many steps, or can be thought of as a description of a series of methods or procedures, each comprising only a subset of the described steps.

[0147] First, a catheter introduction package as shown, for example, in FIGS. 9 and 10 may be prepared (eg, a health care provider / clinician obtains or selects this catheter introduction package from a shelf or by purchase. It can or may be placed in a room with a patient waiting for catheterization). As can be seen from FIGS. 9 and 10, the catheter introduction package may be sealed by (eg, an outer container 60 (eg, a sealed bag); the outer container 60 contains the other contents of the catheter introduction package. Surrounding the contents so that they are kept sterile and properly contained. Paper or thick paper packaging labels 62 may be provided just inside the sealed bag (or other outer container) of the catheter introduction package. The container 60 (or hermetically sealed bag) may be transparent, or at least partially transparent, so that the label 62 or the portion of the label is visible to the clinician. The side surface 64 may be provided so as to extend along the side surface of the catheter introduction package. The label may have one, two, three, or four sides. For example, FIGS. 11 and 12 each have a label 62 having a large top surface portion 66 and three smaller sides, i.e. side portions 64, that can be folded into a plane different from the plane on which the large top surface portion 66 is located. The line on FIG. 12 indicates where a crease can be made to form a side or side portion. In one embodiment, the label has four sides or sides instead of three. It has a portion 64.

[0148] Packaging label 62 may include instructions and / or other information on the label. For example, label 62 may include initial instructions for introducing a catheter. Label 62 is a logo, trademark or product name printed on or otherwise provided on the label (eg, "SureStep ^TM Foley Tray SYSTEM", "Lubri-sil (R) IC Complete Care (R)" and / Or "BARD" may be provided. Label 62 may further, or instead, include instructions written on label 62 relating to catheter introduction, eg, this label. Instructions to confirm whether the patient meets the CDC guidelines for the use of an indwelling urinary catheter, as shown in the lower left quadrant of the upper left portion 66 of the label 62 of FIGS. 9-12. It may comprise (s) 40, which the patient CDCs (eg, as shown in the lower left quadrant of the upper left portion 66 of the label 62 shown in FIGS. 9-12). A checklist 41 may be provided to identify various factors that indicate eligibility for indwelling urinary catheter use under the guidelines; Label 62 is further labeled at Label 62 of FIGS. 9-12. As shown on the right side of the top surface portion 66, a list 42 of the components of the catheter introduction package may be provided. These instructions or other information ensure that the clinician has the instructions or other information. It may be displayed in capital or bold for better visibility for reading, or may be alerted in other ways.

[0149] The packaging label 62 may further comprise basic information or variables that are alerted in a simplified and easy-to-read manner. For example, it may be provided with a visual identifier, a square, another shape, and / or other structure, each having a noticeable and readable display of a piece of basic information or variable. In FIGS. 9-12, the label 62 is shown to include an information square 44, each of which contains a display of a piece of basic information about the catheter introduction package. Information Square 44 essentially isolates and reveals specific information about the catheter introduction tray from a range of possibilities or variables. Various features or variables can be alerted, including: (1) Whether the tray is equipped with a drainage bag or urine meter, (2) the French size of the catheter, (3) the type of catheter included, (4) used in the catheter or other components The substrate type of the material (eg, whether it is a latex material or a material that does not contain latex), (5) a special component or structure (eg, including a StatLock® fixation device), a special infection control coating. Or other structures). Thus, by separating certain variables from everything else and alerting them, health care providers can see at a glance what is in the catheter introduction package or tray. Therefore, the health care provider can quickly determine what is the unique fundamental element of the catheter introduction package or tray. For example, if both the catheter introduction package shown in FIG. 9 and the catheter introduction package shown in FIG. 10 are stored on the same shelf, the health care provider can simply look at Information Square 44 for those catheters. You will be able to quickly identify the major differences between the deployment packages. From the information square 44 of FIG. 9, it is immediately recognizable that the catheter introduction package of FIG. 9 is a non-latex catheter with a French size 18 catheter, a drainage bag and Bard's StatLock®. .. From the information square 44 of FIG. 10, it is readily apparent that the catheter introduction package of FIG. 10 comprises a French size 16 catheter, a drainage bag, and Bard's StatLock®.

[0150] Further, the packaging label 62 may be configured to be visible on many planes. In addition to being visible from above, the label is such that the label (or part of the label) forms visible sides or flanks when the catheter introduction package is viewed from the side. It may be configured to fold at the edge of the catheter introduction package. In FIGS. 9-12, the label 62 is configured such that the information square 44 is visible from above the catheter introduction package and from at least two sides of the tray. Optionally, the label may be configured such that the information square 44 appears on all sides (eg, 3 or 4 sides) of the catheter introduction package. In this way, the label can be seen no matter how the catheter introduction packages are stacked. In addition, many catheter-introduced packages may be stacked on top of each other, but nonetheless, because there is an information square on one or more sides of the catheter-introduced package, the clinician can either from the side of the stacked package. It is possible to quickly identify whether the catheter introduction package is the desired package for a particular patient.

[0151] The catheter introduction package can be selected based on the information square 44 (eg, after looking through the information square 44). After preparing / obtaining / selecting the catheter introduction package, the user can open the container (eg, a sealed bag) and remove it from around the rest of the Tetell introduction package. After the container (or sealed bag) has been removed, the rest of the catheter introduction package appears, for example, as shown in FIG.

[0152] The user can then remove the label 62 and set it aside to expose the other components that were under the label 62. For example, when the label is removed from the catheter introduction package shown in FIGS. 9-11, detailed instructions for catheter introduction or instructions on how to use the catheter introduction package or tray 68, as shown in FIG. 13, for example. Can be exposed. Thereby, detailed instructions and / or information regarding safety considerations are one of the first items accessed within the catheter introduction package. User / Clinician / Health Care by providing detailed instructions at the forefront, prior to any other step and before breaking the sterile field formed by the CSR wrap around the catheter introduction tray. The provider can get an overview of the entire procedure. This helps to carry out the procedure more efficiently and safely. Detailed instructions pages can be found on the various pages of Document 68 of FIGS. 14A-14D. One or more steps included in FIGS. 14A-14D can be performed as an exemplary catheter introduction method or procedure.

[0153] In addition, relevant patient education information can be provided. This patient education information may be attached to the detailed instructions or may be placed separately in the catheter introduction package. This patient education information may be used by the health care provider to instruct the patient regarding the care of the indwelling catheter and may ultimately be given to the patient for reference. FIGS. 15A and 15B show examples of patient education information that can be included on the patient sheet / pamphlet 70 in the catheter introduction tray. FIG. 15A shows the first side of the patient education information sheet 70 written in English, and FIG. 15B shows the second side of the patient education information sheet 70 written in Spanish.

[0154] Under this detailed instruction or usage instructions, the catheter introduction package may include a safety considerations / process checklist, patient information chart, or safety considerations / processes and patient information co-located on the same sheet. It may be provided with an insert sheet including a medical record. FIG. 16 shows an insert sheet 72 on which patient information can be recorded or entered and contains safety information. The insert sheet 72 can be accessed after the detailed instructions have been removed from the package. Placing the insert sheet 72 in this position may be useful for performing a final safety check before treating the patient and for keeping important patient information at hand. The insert sheet 72 may be configured as a sticker label. For example, the insert sheet 72 may be provided with a backing that protects the sticker adhesive, and the insert sheet 72 may be attached to a patient-related file or chart when the backing is removed. ..

[0155] After removing the detailed instructions 68 and the insert sheet 72 from the catheter introduction package, the perineal care (or perineal care) packet or kit 74 can be exposed and accessed as shown in FIGS. 17 and 18. .. The Pericare kit is useful for initial cleaning of the area where catheterization is to be performed, before further cleaning and disinfecting the area with iodine solution. This is especially true for patients who are very dirty and must undergo an initial wash prior to the most effective iodine solution. This perineal kit may include items that are useful for initial cleaning of the patient's perineum or for perineal care in general. For example, as shown in FIGS. 18 and 19, pericare kits include a hand sterilizer 76 (eg, a disinfectant hand rinse gel) for health care providers to disinfect their hands and a wet taolet 78 (eg, disinfectant hand rinse gel). For example, a package of castile soap taolet) and an instruction / procedure display 80 (eg, an instruction / procedure display to a health care provider and / or an instruction to a patient) may be provided. Hand germicides may be configured to have improved efficacy and / or to allow one-handed use.

[0156] As shown in FIGS. 17-19, items from the Pericare kit are included in a bag 82 (eg, a ziplock bag) or other package to keep multiple items / components together. You may. In one embodiment, the type of bag used is a bag with a zipper 84. These types of bags have been found to be easier to open with gloves on than, for example, bags without zippers or bags that must be torn open. However, instead of a zipper or zip lock mechanism, a bag with perforations on the bag is also conceivable. Such bags may be cheaper to manufacture.

[0157] Pericare instruction / procedure display 80 is shown in FIGS. 17-19. Instruction 80 can inform the health care provider that: "1. Wash hands and put on gloves", "2. Explain the procedure to the patient and open the pericare kit", "3. Use the provided taollet packet to peripher the patient's urinary tract" "Clean the area" and "Remove gloves and clean your hands with the provided alcohol hand sterilizer gel." Other instructions / procedures can be displayed. The method may comprise performing some or all of the four steps listed above as instructional steps.

[0158] This method can proceed through three major stages: (A) initial pericare, (B) catheter introduction, and (C) catheter care and maintenance. Each of these stages is indicated on the instruction / procedure display and / or other material with a large "A", "B" or "C" indicating these different major stages. Pericare Instruction 80 As shown above, at the top of the instruction / procedure display is a large "A" indicating that it is the first step. As described elsewhere herein, the band 46 comprises a large "B" indicating the second stage, and the main compartment 1 of the catheter introduction tray has a large "B" indicating the third stage. It has a "C".

[0159] After the pericare kit is removed and used, the band / label packaging 46 may be exposed as shown in FIG. 20 (see also label packaging 140 in FIG. 30B). The band 46 may circle the tray in at least one direction. The band 46 can help keep the CSR wrap intact and maintain a sterile barrier. The band 46 can also help keep all the contents in the tray so that the item does not move around.

[0160] The band / label packaging 46 may include instructions / procedure labels and / or other information on it. For example, as shown in FIG. 20 (see also FIG. 30B), the band provides instructions / procedure indications to inform the health care provider in what orientation the tray should be placed for the patient. May be good. For example, this band may say "point towards the insertion site," which is the end of the catheter introduction tray that should be placed closest to the patient's perineum and urinary tract. It may have an arrow pointing to. This ensures that when the CSR wrap is opened, the tray is properly positioned for the most logical and intuitive use.

[0161] Further, as shown in FIG. 20 (see also label packaging 140 in FIG. 30B), the band 46 may be provided with the following instruction / procedure indication, "proper sterility technique". "(1) Open the CSR wrap", "(2) Wear sterile gloves", "(3) Lay underpads", "(4) Apply window drapes" "Masu" and (5) "Follow the tray instructions". These instructions / procedure indications are provided at the top with a large "B" indicating that these instructions / procedure indications are part of a second stage, the catheter introduction stage. These instructions / procedure indications inform the health care provider that the CSR wrap is to be opened and that other steps will be performed after the CSR wrap has been opened. Providing this information before breaking the sterile barrier gives the health care provider an opportunity to review the procedure in advance and prepares the health care provider when the sterile barrier is broken by opening the CSR wrap. Make sure you are done. Optionally, a label or sticker may be used in place of the band, which label or sticker may provide the same information as the band described herein.

[0162] After the tray has been oriented and the health care provider has read the band instructions / procedure display, the next step is to open and / or remove the band. After removing the band, the sterile wrap 56 (eg, CSR wrap) can be opened. FIG. 21 shows a catheter introduction tray in which the three corners of the sterile wrap 56 are widened to represent the spreading of the sterile wrap 56. Note that the sterile barrier of the catheter introduction tray and its components has not been broken until the band and sterile wrap have been opened. This maintains a sterile barrier while the initial pericare stage is completed and while the tray is placed in the proper position and orientation for catheter introduction. Leaving the sterile barrier intact during these initial steps of this method reduces the chances of contamination and consequent patient infection.

[0163] When the catheter introduction tray is placed in the orientation indicated by the band 46, when the sterile wrap 56 (eg, CSR wrap) is opened, the tray becomes a logic of the catheter introduction tray and its components. Placed in the proper orientation for targeted and convenient use. This tray is arranged and ordered for the stepwise logical use described herein. An initial view of the tray after the sterile wrap 56 is completely opened is shown in FIG. (A break line is used to show that the actual edge of the sterile wrap 56 extends beyond the break edge shown in FIGS. 22-29.) A sterile field for catheter introduction. Note that the sterile wrap 56 may remain under the catheter introduction tray to form. The tray shown in FIG. 22 and other figures stands near the lower edge of the catheter introduction tray and provides right-handed health care when the syringe or catheter compartment is located far from the health care provider. Designed for right-handed people for ease of use (ie, if the band points towards the genital organ between the legs, the right-handed user is the patient's right leg Stand on the side closer to). Alternatively, the catheter introduction tray may be for left-handed people (eg, in FIGS. 22-29 with a mirror located essentially along the side surface 7 of the tray or along the syringe or catheter compartment. Mirror image of the tray shown).

[0164] After opening the CSR wrap first, as instructed on the band 46, the health care provider then puts on the sterile gloves provided in the tray. As shown in FIG. 22, it should be noted that the top item in the tray after the CSR wrap has been opened is the sterile glove package 58 (the cuff end of the glove can be shown on the package 58). sea bream). Aseptic gloves may be made from materials known to be suitable (eg, latex materials, rubber materials, or latex-free materials). Placing gloves in this way on top of the tray under sterile wrap helps health care providers intuitively know that gloves should be worn before proceeding (intuitively). Therefore, it may not be necessary to refer to the instruction / procedure display on the band 46 again). The glove package 58 can be opened as shown in FIG. 23 by folding the cuff downwards towards the health care provider and then opening the package to open the book. A left-handed glove is placed on the left side of the health care provider and a right-handed glove on the right side of the health care provider to facilitate wearing gloves when opened in this intuitive and logical manner. Is placed. Symbols or other markings may be provided on the package 58 to identify the left and right gloves, for example as shown in FIG.

[0165] After wearing the gloves, as instructed on the band 46, the health care provider lays an underpad under the patient's hips. As shown in FIG. 24, the underpad and windowed drape are exposed after the glove package is removed from the tray. The folded pad / drape 86 shown in FIG. 24 represents (1) a waterproof underpad and (2) a separate windowed drape. The underpad may have a waterproof surface and a liquid absorbent surface. In that case, the absorbent surface is placed face up under the patient and the waterproof surface (or plastic surface) is placed face down. After laying the underpad as directed on the band 46, the health care provider applies the fenestrated drape to the patient so that the genitals are visible through the central opening of the fenestrated drape. In FIG. 24, the underpad and the windowed drape are not shown as separate, but both are provided in the area of the pad / drape 86, with the underpad on top of the windowed drape. (Ie, this is because the underpad is laid first, which exposes the windowed drapes that are subsequently applied). This windowed drape is logically arranged and folded so that it can be intuitively understood that the drape opens away from the clinician. This point is preferable in using the drape most advantageously.

[0166] After applying the windowed drape, as instructed on the band 46, the health care provider follows the instructions / procedure indications and / or performs the steps written on the catheter introduction tray. .. As shown in FIG. 25, removal of the underpad and windowed drape exposes the disinfectant solution (eg, povidone iodine solution) package 52. (Note that FIG. 25 shows a windowed drape moved from above the swab compartment 3 into the main compartment 1. The drape is moved in this way or the windowed drape is applied to the patient. And the disinfectant in the swab compartment is exposed). In addition, on the left side of the tray, you can see the first instruction / procedure display 47 on the tray (ie, "(1) Iodine is opened"; variants of this instruction or other instructions are possible) (band 46). The left side of the tray is also the side closest to the area where the patient and catheter are introduced) when placed in the orientation as instructed by. Since people read English from left to right, it is logical to put the first instruction 47 on the left, and it is intuitive to start with the instruction on the left (do not read from left to right). In the country, this can be adjusted). In addition, this instruction / procedure indication is located near the disinfectant or iodine solution 52 in the tray, which makes it easier and more intuitive to follow this instruction / procedure indication.

[0167] Assuming the clinician is right-handed and the tray is placed in the orientation indicated by the band 46, the disinfectant or iodine solution 52 is automatically placed closest to the patient. To. (However, as mentioned above, if the tray is made for left-handed people (eg, essentially a mirror image of the tray in the figure), use a left-handed person with the tray arranged as directed by the band. One can also place another, such as automatically placing the disinfectant or iodine solution closest to the patient (for example, a left-handed clinician is on the side of the tray where the right-handed clinician stands). Standing on the opposite side or closer to the patient's left leg).) Placing the disinfectant or iodine solution (and swab compartment) closest to the patient is preferred for use with the tray. It is beneficial to place the swab compartment 3 and the well of the iodine solution closest to the patient. This is because doing so prevents the swab saturated with the disinfectant or iodine solution from being dragged or moved across the tray (moving the swab across the other components of the tray). If so, a swab can drop on those components).

[0168] FIG. 26 shows a catheter introduction tray after removal of the povidone iodine solution. Note that taking out the disinfectant or iodine solution packet 52 exposes the swab or swab stick 34 and the second instruction / procedure display 48 on the tray. This intuitively leads the health care provider to logically follow the second instruction 48 after lifting a packet of disinfectant or iodine solution. The second instruction 48 on the tray is in the swab compartment 3 and displays "(2) Pour iodine here →" and points to the lowest / deepest location or well of the swab compartment 3 (this instruction). Modifications or other instructions are also possible). When the disinfectant or iodine solution is poured onto the barrier or groove of the swab compartment 3, its inclination ensures that the solution flows to the lowest / deepest location or well.

[0169] After the health care provider has poured the disinfectant or iodine solution into the wells of swab compartment 3 so that the swab's absorbent head begins to absorb the disinfectant or iodine solution, the health care provider then A syringe 88 of sterile solution can be attached to the inflatable port of the catheter 92 (eg, Foley catheter) as directed by the third instruction / procedure display 49. Third instruction 49 is not far from the well of the swab compartment where the health care provider has just poured the disinfectant or iodine solution, and is near the sterile solution syringe used in the third instruction. Is logically arranged on the side surface 7 of the tray. The third instruction 49 indicates "(3) Attach the water syringe" (variations of this instruction or other instructions / procedure indications are also possible). FIG. 27 shows a syringe 88 of sterile liquid or sterile water after being attached to the inflatable port of the catheter 92.

[0170] After the sterile fluid syringe 88 is removed from the syringe or catheter compartment, the fourth instruction / procedure indicator 50 (previously hidden by the sterile fluid syringe) is exposed. The fourth instruction 50 may inform the health care provider that: "(4) Lubricate the catheter" or "(4) Lubricate the dispensing and foley here" or similar content (again, this instruction can be modified or other instructions / procedures can be displayed. be). In fact, catheter lubrication is the next step performed by the health care provider. To do this, the health care provider removes the lubricating jelly syringe 89. This removal exposes the fifth, sixth and seventh instruction / procedure indications previously hidden by the lubricating jelly syringe 89. According to the present disclosure, the lubricating jelly can be provided in other suitable containers well known to those of skill in the art, and non-limiting examples of containers include bellows, ampoules, or the like. The health care provider may then lubricate the catheter in the desired manner. In one embodiment, the health care provider removes the plastic wrap 90 (shown in FIGS. 27, 28) from the top of the catheter 92, which may be a Foley catheter, and removes a portion of the catheter 92. , For example, move into the syringe or catheter compartment 2 as shown in FIG. 28. Placing the distal end 94 of the Foley catheter 92 within the syringe or catheter compartment 2 helps align the catheter 92 for lubrication and catheter introduction. For example, as shown in FIG. 28, when the distal end 94 of the catheter 92 is placed near the side of the syringe or the left end of the catheter compartment 2, the distal end 94 of the catheter 92 is introduced with the patient and the catheter. Placed very close to the area (assuming the tray is placed in the orientation indicated by the band 46). Further, the distal tip of the catheter 92 is essentially positioned such that the distal tip of the catheter 92 points to the area where the catheter is introduced so that the health care provider simply lifts the catheter 92. , The catheter 92 is moved a short distance in the direction pointed to by the catheter 92 and is positioned so that insertion of the catheter 92 into the patient can begin. After the catheter 92 is placed in the syringe or catheter compartment 2, the user can dispense the lubricating jelly from the syringe 89 onto the distal portion of the catheter 92 in the syringe or catheter compartment 2 (eg,). , The syringe can be dispensed near the patient on the left side of the syringe or catheter compartment and the area where the catheter is introduced), in a lubricating jelly to ensure that the catheter 92 is properly lubricated. The catheter 92 can be twisted.

[0171] The above lubrication method is beneficial for the reasons described above, but other methods of lubricating the catheter 92 are also possible. In one embodiment, the health care provider may dispense the lubricating jelly onto a portion of the sterile / CSR wrap around the tray and place the end of the catheter in the lubricating jelly for lubrication. In one embodiment, prior to moving the catheter 92 from the main compartment 1, the user dispenses the lubricating jelly directly into the syringe or catheter compartment 2 and then into the lubricating jelly the catheter 92. The distal portion may be moved.

[0172] After lubricating the catheter 92, the health care provider temporarily leaves the catheter 92 in the syringe and catheter compartment 2, while the health care provider uses his non-dominant hand to slaughter the reproductive organs. The patient may be retreated and the dominant hand is used to prepare and disinfect the patient with a swab or swab stick saturated with a disinfectant or iodine solution. As mentioned above, twist the swabs or swab sticks (eg, the swabs or swab sticks 34 described above having the absorbent head 36 and the rod 38) clockwise or counterclockwise to easily release them from the grooves of the swab compartment. be able to. Each swab or swab stick is preferably used for only one swipe to the patient. For female patients, (1) stroke one swab or swab stick downwards to wash the right labia minora, discard the swab or swab stick, and (2) stroke another swab or swab stick downwards. Then wash the patient by washing the left labia minora, discarding the swab or swab stick, and (3) using a third swab or swab stick to wash the central area between the labia minora. be able to. For male patients, the patient can be washed by swabs or swab sticks in a circular motion starting from the urethra and moving outwards. After preparing and disinfecting the patient in this way, the health care provider uses the dominant hand to insert a catheter into the patient's bladder so that urine is visible in the tube when the catheter enters the bladder. However, an additional 50.8 mm (2 inches) should be inserted from this point to allow the retention balloon to enter the bladder), from the sterile fluid syringe 88 into the catheter 92 via the inflatable port. Inflate the retention balloon in the bladder by injecting sterile fluid. In fact, these steps are the steps designated on the tray as the fifth step, the sixth step and the seventh step, and each of these steps is described as follows. "(5) Retract the genitals (non-dominant hand)", "(6) Prepare the patient with a swab (dominant hand)", and "(7) Insert the catheter and inflate the balloon. (Dominant hand) ". Modifications of these instructions / procedure displays or other instructions / procedure displays are also possible. After inflating, the health care provider can gently pull the catheter until the inflated balloon fits snugly against the bladder neck. These steps complete the catheter introduction step or step "B" of the procedure.

[0173] FIG. 29 shows what the tray looks like immediately after the catheter is properly placed in the patient's body. Note that the drainage tube 95 easily follows the catheter 92 and exits the tray towards the patient. A folded urine collection bag 96 is located within the main compartment 1 of FIG. 29, with the urine collection bag 96 pre-connected to a tube 95, a catheter 92 and / or other components of the catheter assembly. It may be packaged in. The urine collection bag 96 may be unfolded and suspended below the patient to collect urine when it is drained from the patient.

[0174] After the patient's catheter introduction (ie, after the catheter is inserted into the patient's bladder and the retention balloon is inflated), additional steps may be performed. For example, in stage "C", i.e., the care and maintenance stage, the health care provider may: (1) Immobilizing a Foley catheter to the patient (eg, using a StatLock® device), (2) placing a urine bag and / or urine meter below the patient's bladder (eg, using a StatLock® device). (Hang the bag on a hanger on the bed rail under the bed), secure the tube to the bed sheets (eg with an m-clip) to prevent the tube from twisting, (3) label and / or catheter (eg figure) Record the date of insertion by displaying the date and time of catheter insertion on the label / sheet 72) shown in 16 and record the procedure according to hospital procedures, (4) maintain the catheter (eg, the catheter is sterile). If you have a red seal, keep it), (5) reassess the need for an indwelling catheter, and routinely assess whether the catheter is unnecessary, (6). And / or other care or maintenance steps.

[0175] Step "C" and associated instruction / procedure indications are identified within the main compartment of the catheter introduction tray, as shown in FIGS. 1, 2, and 5. The step "C" instruction / procedure display includes, for example, the following instruction / procedure display. "(1) Use StatLock® to secure Foley", "(2) Place the bag below the bladder", "Use clips to secure the tube to the sheets" , "(3) Record the date of insertion", "(4) Maintain the red seal according to hospital policy", "(5) Evaluate the need for catheters on a daily basis". Modifications of these instructions / procedure displays or other instructions / procedure displays are also possible. Urine samples may be collected as instructed in FIG. 14D. Finally, the catheter may be removed as instructed in FIG. 14C.

[0176] The catheter introduction packages (s) and catheter introduction trays (s) described herein can be manufactured / packaged in a variety of ways. For example, the manufacturer or distributor of a catheter-introduced package may modify or reorder the steps described herein as required by circumstances and specific needs. Additional steps other than those performed may be performed and / or certain steps may be omitted. In addition, the features, components, arrangements, components and component ordering described above (eg, features or arrangements that make the use of the catheter introduction package more intuitive or more logical) are available during manufacturing (eg,). It may be added to the catheter introduction package (in the manufacturing / packaging method), or it may be provided in the catheter introduction package. However, the following describes non-limiting manufacturing / packaging methods. The steps described herein may be performed in the order described or in a different order.

[0177] In one embodiment, a catheter is provided by providing a catheter introduction tray (eg, a catheter introduction tray similar to the tray shown in FIGS. 1-5 described above, or a catheter introduction tray having features thereof). The introductory package is manufactured / packaged. This tray may be purchased or formed by the manufacturer of the catheter introduction package. When manufactured, trays may be formed using an injection molding process or other suitable process. Instructions / procedures may be integrated, printed, or otherwise provided on the trays described above and shown, for example, FIGS. 1, 2, and 5.

[0178] Various components (eg, any component discussed above or elsewhere herein) may be added to the tray. In one embodiment, a pre-connected drainage system may be added / provided to the tray (eg, main compartment 1) as shown in FIG. The drainage system may include a drainage / collection bag 96, a drainage tube 95, a catheter 92 (eg, a Foley catheter), a drainage outlet, a urine meter, or other drainage component. As shown in FIG. 8 or 26, a swab or swab stick 34 may be added / provided to the tray (eg, main compartment 1). As shown in FIG. 26, a sample or sample container 54, and a label on which details about the sample can be filled in and affixed to the sample or sample container, have been added to the tray (eg, corner storage compartment 5). May be provided. As shown in FIG. 25, a packet or container 52 of the disinfectant skin cleanser (eg, a packet or container of povidone iodine solution) is added / provided on the tray (eg, on the swab stick 34 in the swab compartment 3). You may. As shown in FIG. 26, a packet or container 89 of lubricant (eg, a syringe of lubricating jelly) may be added / provided to the tray (eg, syringe or catheter compartment 2). As shown in FIG. 26, a sterile fluid syringe 88 (eg, a 10 cc syringe of sterile water for inflating a holding balloon for a Foley catheter) is a tray (eg, a syringe or a lubricating jelly syringe 89 in catheter compartment 2). May be added / provided on or partially above). As shown in FIG. 24, a windowed drape for the patient may be added / provided on a tray (eg, above other components) and may span parts of two or more compartments. .. An underpad under the patient's hips (eg, a waterproof absorbent underpad) may be added / provided to the tray (eg, over a windowed drape or other component) and more than one. It may straddle a portion of the compartment. In the figure, both the underpad and the windowed drape are represented by the pad / drape 86. As shown in FIG. 22, gloves (eg, rubber gloves, latex gloves, latex-free glove packages 58) are added / provided on trays (eg, on underpads or other components). It may also span parts of two or more compartments.

[0179] The tray and components may be sterile and a sterile wrap 56 (eg, a CSR wrap) may be folded or wrapped around a catheter introduction tray as shown in FIGS. 20-21. You may. As shown in FIG. 20, a band 46 (eg, a band that helps keep the sterile wrap in a folded form and keeps all contents inside the tray, so the item does not move around) is the sterile wrap. It may be provided around 56. As shown in FIGS. 17 and 18, a perineal care (or perineal care) packet or kit 74 (eg, shown in FIGS. 17-19) may be added / provided in the catheter introduction package. For example, it may be placed on a band 46 and / or a sterile wrap 56. The perineal care packet or kit 74 includes a hand disinfectant 76 (eg, a hand rinse gel for disinfection), a wet taolet 78 (eg, a package of castile soap taolet), an instruction 80 (eg, an instruction for a health care provider). , And / or instructions for the patient), and / or may include other components (see, eg, FIG. 19). As shown in FIG. 16, an insert sheet or label 72 with instructions or other information may be added / provided to the catheter introduction package, eg, safety considerations / process checklists, and / or. An insert sheet or label 72 with a patient information chart may be provided on top of the perineal care packet or kit. As shown in FIG. 13, detailed instructional documents (eg, shown in FIGS. 14A-14D) and / or patient education information (eg, shown in FIGS. 15A, 15B) are added to the catheter introduction package. / Provided, for example, Usage (DFU) Document 68 and / or Patient Education Brochure 70 may be provided on the insert sheet. A packaging label 62 (eg, the packaging label described above and shown in FIGS. 9-12) may be added / provided to the catheter introduction package (eg, on top of all other components) and has an edge. It may be bent downwards to cover the sides of the catheter introduction tray. As shown in FIGS. 9 and 10, the catheter introduction package may be sterilized and sealed (eg, in a sealed container or bag 60). Other components useful for catheterization or care may be provided.

[0180] In one embodiment, the catheter introduction system is a ureteral catheter assembly and / or a material or source (eg, bactericide, lubricant, swelling solution, gloves) suitable or necessary for the ureteral catheter introduction procedure. Such as catheter introduction element or component) may be provided. For example, a catheter introduction system has a catheter introduction tray with multiple compartments for accommodating and / or immobilizing a ureteral catheter assembly (eg, an assembly with a Foley catheter) and other sterile and / or non-sterile catheter introduction elements. You may be prepared. This sterile and / or non-sterile catheter introduction element includes any of those mentioned above. The sterile catheter introduction element may be housed in a catheter introduction tray in a form that is not contaminated by the non-sterile catheter introduction element.

[0181] The catheter introduction tray may include one or more visual procedure indications or instructions that may assist the user during the catheter introduction procedure. For example, this procedure display is intended for the patient so that the catheter introduction component and / or the element can be placed in a predictable and appropriate or desired position and / or orientation for the user and / or the patient. It can assist the user in orienting the catheter introduction tray (and its catheter introduction component or element). In addition to, or instead, this procedural display may assist the user in determining the order of use of the catheter introduction component and / or removal of the catheter introduction component from the catheter introduction tray. can.

[0182] As mentioned above, catheter introduction trays and systems with such trays can facilitate sterility techniques during the catheter introduction procedure. In one embodiment, as shown in FIG. 30A, the catheter introduction system 100 comprises a catheter introduction tray and a container 110 (eg, a sealed bag) capable of hermetically sealing or accommodating catheter introduction components. For example, the container 110 can facilitate maintaining the sterility of the sterile catheter introduction component. For example, the container 110 may be a plastic bag (for example, a polyethylene bag). Further, the container 110 may be provided with a strippable side 111, which can be separated from the non-stripping side 112 to form an opening in the container 110. (The above container 60 may also have similar characteristics and properties), through this opening, the contents located within the container 110 can be removed.

[0183] In one embodiment, at least a portion of the catheter introduction tray and its contents (ie, catheter introduction components) may be at least partially surrounded or surrounded by the identification cover 120. In one embodiment, the packaging label or identification cover 120 (eg, similar to packaging label 62 described above) is one or more visual identifiers (eg, visual identifiers 121, 122, 123) containing basic information or variables. For example, these identifiers may be similar to the information squares described above), and the identifiers may provide a representation related to the type and / or contents of the catheter introduction system 100. can.

[0184] For example, the packaging label or identification cover 120 may be made of a sheet-like material such as paper, cardboard, plastic (eg, plastic film). The visual identifiers 121, 122, 123 may be configured to convey sufficient information for the user to identify the specific type and / or its contents of the catheter introduction system 100. For example, the visual identifier 121 can identify the size of the catheter (eg, French size 16 and the like). In one example, the visual identifier 122 may indicate a urine meter (which may be attached to a catheter) by the catheter introduction system 100 and / or the visual identifier 123 may indicate that the catheter introduction system 100 is a catheter. It may indicate that it has a stabilizing device (eg, STATLOCK).

[0185] The visual identifiers 121, 122, 123 may be visually separated or isolated from each other. For example, the visual identifiers 121, 122, 123 may comprise a substantially square or rectangular perimeter contour that can demarcate or form its outer contour. In other words, the identification information of the visual identifiers 121, 122, 123 may be included in the contour line of the substantially rectangular shape of the visual identifiers 121, 122, 123. Thus, for example, the user can easily and / or quickly locate relevant information on the identification cover 120 in order to identify and / or select a particular catheter introduction system 100 suitable for the procedure.

[0186] One, some or all of the visual identifiers 121, 122, 123 may comprise a visible display or information that can inform the user about the details of the catheter introduction system 100. For example, the visual identifiers 121, 122, 123 may include characters, images, symbols, and the like. In addition, the visual identifiers 121, 122, 123 and / or parts thereof have a suitable color or numerous colors that can assist the user in identifying and / or distinguishing the visual identifiers 121, 122, 123. You may be doing it. In one embodiment, at least one of the visual identifiers 121, 122, 123 may have a different color than the other identifiers.

[0187] It should be understood that the specific contour shape, size, thickness or combination thereof of the contour surrounding or including the identification information of the visual identifiers 121, 122, 123 can be varied from embodiment to embodiment. Is. Therefore, the visual identifiers 121, 122, 123 may have a substantially circular, triangular or polygonal shape. In addition, the identification cover 120 may contain any number of suitable materials that can carry the visual identifiers 121, 122, 123 and can be varied from embodiment to embodiment. For example, the visual identifiers 121, 122, 123 may be printed, embossed, or otherwise transferred onto the identification cover 120.

[0188] The identification cover 120 may include any number of visual identifiers. In other words, the visual identifiers 121, 122, 123 may be placed in any number of suitable locations on the identification cover 120 and / or may be duplicated. For example, the identification cover 120 may be provided with visual identifiers 121, 122, 123 on its primary surface and its secondary surfaces. In one embodiment, the visual identifiers 121, 122, 123 may be located on one, part or all of the visible surfaces of the catheter introduction system 100 (eg, during storage thereof, the visual identifier 121). , 122, 123, in part or in whole, may be visible from any side of the catheter introduction system 100).

[0189] The identification cover 120 may be removable from the catheter introduction tray. For example, the identification cover 120 may be entirely removed from the catheter introduction tray (eg, the identification cover 120 may be on the catheter introduction tray and is secured to the catheter introduction tray by the container 110. May be good). Further, as shown in FIG. 30B, the catheter introduction tray may be exposed by removing the identification cover, the catheter introduction tray being wrapped by or in a sterile wrap 130 of the Central Material Room (CSR). May be good. Thus, the CSR sterile wrap 130 can secure components within the catheter introduction tray, at least temporarily.

[0190] The CSR sterile wrap 130 may be opened and removed from the catheter introduction tray or used during the catheter introduction procedure. For example, in order to provide an at least partially sterile environment near the site of the catheter introduction procedure, thereby reducing the risk of infection associated with the catheter introduction procedure, the CSR sterile wrap 130 is near and / or near the patient. It may be placed under the patient. The CSR sterile wrap 130 may be substantially opaque. As a result, the contents of the catheter introduction tray and / or the location of the catheter introduction component are hidden or invisible to the user. Optionally, the CSR sterile wrap 130 may be translucent or transparent. As a result, the user can see and / or visually identify the catheter introduction component housed in the catheter introduction tray.

[0191] The catheter introduction system 100 may include a band or directional packaging 140, which band or directional packaging 140 may not be visible to the user relative to the components in the catheter introduction tray. Position and / or orientation indications can be provided. For example, the band or label packaging 140 may include a directional arrow 141. The user can point the directional arrow 141 towards the catheter insertion site, thereby orienting the catheter introduction tray and the catheter introduction component within the tray with respect to the patient. For example, by orienting the catheter introduction tray so that the directional arrow 141 aligns with the direction of the insertion site, the catheter introduction components and / or elements can be arranged at least partially in sequence. As a result, the catheter introduction component and / or component to be used in the relative early stage of the procedure is placed closer to the patient than the catheter introduction component intended to be used in the relative late stage of the procedure. To.

[0192] In addition, the band or label packaging 140 may include a warning label 142 to warn the user of proper sterility techniques for the catheter introduction procedure. For example, the warning display 142 may include one or more specific elements that identify specific steps suitable for or required for proper sterility procedures. In one embodiment, the warning display 142 identifies one or more of the following steps: (1) A process of opening the CSR sterile wrap 130, (2) a process of wearing sterile gloves, (3) a process of laying an underpad, (4) a process of applying a windowed drape, or (5) a catheter introduction tray. A process that follows the process identified by the procedure display located inside.

[0193] Labeling packaging 140 can be wrapped around a CSR sterile wrap 130, but the present disclosure is not limited thereto. For example, the sticker or adhesive label may be affixed to a CSR sterile wrap and may have the same or similar labeling as the labeling packaging 140. Alternatively, or in addition, the display may be placed directly on the CSR sterile wrap 130 (eg, may be printed, embossed or otherwise transferred to the CSR sterile wrap 130). ..

[0194] After the CSR sterile wrap 130 has been removed or opened from the catheter introduction tray, the contents of the catheter introduction tray can be exposed. FIG. 31A shows the catheter introduction tray 200 of the catheter introduction system 100. The catheter introduction tray 200 may include a number of compartments capable of fixing or accommodating various catheter introduction components. The shape and size of the catheter introduction tray 200 can be defined by its sides. For example, the sides 201, 202, 203, 204 may define a substantially rectangular outer shell or outer circumference of the catheter introduction tray 200.

[0195] The catheter introduction tray 200 may be formed by molding (eg, injection molding, thermoforming) or stamping (eg, from plastic material). Therefore, the sides 201, 202, 203, 204 may be formed from a sheet-like material. One or more of the sides 201, 202, 203, 204 comprises a reinforced rib 205 capable of providing rigidity and / or stiffness to the sides 201, 202, 203, 204. It is also good. The reinforced rib 205 may have a generally tapered shape and / or may project outward from the corresponding side surfaces 201, 202, 203, 204, respectively. More specifically, for example, the lower part of the reinforced rib 205 (the part near the bottom / floor of the catheter introduction tray 200) is larger than the upper part of the reinforced rib 205 (the part near the opening of the catheter introduction tray 200). , May project significantly from the corresponding sides 201, 202, 203, 204, respectively. At least a portion of one, some or all of the reinforcing ribs 205 may have a partially conical shape.

[0196] The catheter introduction tray 200 may include a swab compartment 210, the swab compartment 210 may include one or more swabs 150 therein. In addition to or instead, compartment 210 may comprise a cleaning / disinfectant or disinfectant packet 160, wherein the cleaning / sterile solution or disinfectant packet 160 (including, for example, a povidone iodine solution). It may be equipped with one or more disinfectants or cleaning / disinfecting solutions. The compartment 210 may be located near the side surface 201 of the catheter introduction tray 200 and may be at least partially defined by the side surface 201. In some cases, the outer surface of the disinfectant packet 160 may not be sterile. Thus, the cleaning / disinfectant or disinfectant packet 160 may be placed in a separate package or bag, which may have a sterile outer surface. This sterile outer surface can prevent or reduce contamination of other catheter introduction components within the catheter introduction tray 200 with a non-sterile wash solution or disinfectant packet 160. The plastic bag may be equipped with a zipper or similar mechanism that can be manipulated by the user to open and / or access the packet 160 and other components within the packet 160.

[0197] The catheter introduction instruction may comprise images and descriptions of various steps or actions performed during the catheter introduction procedure. In some cases, the instructions may further identify a particular step number or action number, which suggests a particular sequence of steps or actions for the catheter introduction procedure. Catheter introduction instructions (which may not be sterile) may be placed in a sterile container such as a plastic bag, whereby non-sterile instructions are given from the sterile catheter introduction component in the catheter introduction tray 200. Can be isolated or separated. In addition, in some examples, the catheter introduction system may include a large number of sets of catheter introduction instructions, which can improve adherence to aseptic catheter introduction procedures. For example, catheter introduction instructions are given inside a sterile plastic bag (eg, as a sticker) and / or other catheter introduction elements or components (eg, in a sterile container with disinfectant packet 160), of the catheter introduction system. It may be attached or attached to an external sleeve or the outside.

[0198] The compartment 210 may be configured to contain a disinfectant (eg, a liquid), which may be dispensed into the compartment 210 from the disinfectant packet 160. For example, as described in detail below, compartment 210 may have a sloping bottom / floor. As a result, the cleaning or disinfectant (eg, povidone iodine solution) or disinfectant from packet 160 is near the lowest corner between the bottom / floor of compartment 210 and the sides (eg, partition 211) and /. Or it can collect at its corners. Further, the tip of the swab 150 may be located at or near the lowest corner between the bottom / floor and sides of the compartment 210. As a result, the tip of the swab 150 is placed in the dispensed disinfectant or disinfectant.

[0199] Partition 210 may be at least partially formed by its side surface 201 or part of its inner sidewall, partition 211, partition 212 and sloping bottom / floor. For example, the lowest portion of the compartment 210 may be located at the corner side formed between the partition 211 and the sloping bottom / floor by the partition 211 and the sloping bottom / floor. Therefore, by placing the tip / absorbent head of the swab 150 near the sloping bottom / floor and / or partition 211 of the partition 210, the tip of the swab 150 at or near the lowest portion of the compartment 210. / Absorbent head can be placed.

[0200] As described above, the catheter introduction tray 200 for the patient may be oriented such that the side surface 201 and compartment 210 are located closer to the insertion site than the side surface 203 of the catheter introduction tray 200. In other words, by orienting the catheter introduction tray 200 based on the direction arrow of the directional packaging (with the contents and compartment of the catheter introduction tray 200 hidden or covered by the CSR sterile wrap 130 (FIG. 30B)). ), Sides 201 and compartment 210 can be placed near the insertion site. In some cases, the insertion site may first be sterilized using a swab 150 that can be saturated with the disinfectant solution from the disinfectant packet 160. Therefore, placing the compartment 210, along with the swab 150 and the disinfectant packet 160, near the insertion site will cause the disinfectant to spill (eg, onto one or more catheter introduction components in the catheter introduction tray 200). And / or can reduce contamination of the swab 150 which can lead to contamination of the insertion site.

[0201] As described in detail below, compartment 210 may have a sloping bottom / floor. For example, the upper edge portion (or upper surface) such as the upper edge portion 206 of the catheter introduction tray 200 may be in the virtual plane. This virtual plane may be substantially parallel to a support surface (eg, the surface of the patient's bed) that can support the catheter introduction tray 200. The sloping bottom / floor of compartment 210 may have an orientation that is not parallel to the virtual plane and / or support plane of the top edge 206.

[0202] Further, the bottom / floor of the compartment 210 may be non-parallel to the bottom / floor of one or more other compartments in the catheter introduction tray 200. For example, the catheter introduction tray 200 may be placed on the support surface. As a result, the bottom / floor of one or more compartments supports and / or orients the catheter introduction tray 200 on the support surface. Therefore, as described above, the bottom / floor of the compartment 210 can have an orientation that is not parallel to the support plane.

[0203] The catheter introduction tray 200 may include a side compartment 220. For example, compartment 220 may extend substantially along the entire or overall length of one side of the catheter introduction tray 200 (eg, compartment 220 extends between side 201 and side 203). And / or may be partially formed by it). Therefore, in some cases, one side of the compartment 220 may be formed by the sides (eg, by the side 204).

[0204] Section 220 may comprise any number of suitable components or components of the catheter introduction kit. For example, compartment 220 may include a syringe 170 containing a liquid that can be used to inflate a balloon (discussed below) of the catheter and / or a syringe 180 that may contain a lubricant. Therefore, the width of the compartment 220 may be large enough to accommodate the syringes 170, 180. In some cases, the syringes 170, 180 may be oriented lengthwise along the compartment 220 or may be aligned within the compartment 220. That is, the other syringe may be placed in front of one syringe.

[0205] The catheter introduction tray 200 may include one or more notches or recesses in partition 221 which, the notches or recesses, from adjacent compartments (s) (eg, catheter compartment 230). The compartment 220 may be separated. For example, one or more recesses in the partition 221 may include an apical edge located below the upper edge 206 of the catheter introduction tray 200. More specifically, in some cases, this recess may provide access to one or more syringes 170, 180 from compartment 230. Thus, the user of the catheter introduction kit can remove the syringe 170 and / or the syringe 180 by inserting the finger into the compartment 220, or in addition, by inserting the finger into the compartment 220.

[0206] In one embodiment, the size of the syringe 170 and the syringe 180 may be different. Therefore, in one embodiment, the width of at least one portion of the compartment 220 may be smaller than the other portion of the compartment 220 so that different sized syringes 170, 180 can be accommodated. For example, the compartment 210 may include a narrow protrusion 222, which extends into the space of the compartment 220, thereby narrowing the width of a portion of the compartment 220. May be good. For example, the syringe 170 may have a smaller diameter or perimeter size than the syringe 180. Thus, the narrow protrusion 222 can narrow the width of the compartment 220 that may have sufficient width to accommodate the syringe 180 (eg, the narrow protrusion 222 allows the syringe 170 to be within the compartment 220. Can prevent or limit lateral movement).

[0207] As described above, the catheter introduction tray 200 may include a main compartment or catheter compartment 230. The compartment 230 may have a substantially rectangular shape. For example, the compartment 230 and its shape may be at least partially formed by the side surface 203, at least a portion of the side surface 202 and the partitions 212,221. In one embodiment, the compartment 230 may have a substantially rectangular shape, but it should be understood that the shape of the compartment 230 can be varied from embodiment to embodiment.

[0208] In any case, the size (eg, perimeter and depth), shape or configuration of the compartment 230 may accommodate the catheter assembly 190. For example, the catheter assembly 190 may include a catheter 191 that can be connected to a urine collection bag and / or a urine meter 192. In some cases, compartment 230 may further accommodate STATLOCK 193. STATLOCK193 can secure at least a portion of the catheter assembly 190 during the catheter introduction procedure.

[0209] As described in detail below, compartment 230 may have a substantially flat or substantially flat bottom / floor. For example, the bottom / floor of compartment 230 may support the catheter introduction tray 200 on a support surface. Thus, in one embodiment, the bottom / floor of compartment 210 may have an orientation that is not parallel to the bottom / floor of compartment 230.

[0210] As described above, the compartment 230 may have a substantially rectangular shape. Further, the compartment 230 may have a round or chamfered internal corner 231 between the inner and inner sidewalls forming the perimeter of the compartment 230. In addition to or instead, the inner sidewall and / or the upper part of the partition may have one or more chamfers or fillets 232. The chamfers or fillets 232 may extend at least partially along their respective corresponding lengths.

[0211] The catheter introduction tray 200 may further include an auxiliary compartment 240 capable of accommodating an auxiliary container 195 (eg, a sample or sample container). For example, the auxiliary container 195 may be substantially cylindrical or may be provided with a cap. Further, the shape, size and configuration of the compartment 240 may be such that the auxiliary container 195 is fixed in the compartment 240. In one embodiment, the length of the compartment 240 may be equal to the length of the auxiliary container 195 (eg, the compartment 240 may have a small clearance or may be tight with the auxiliary container 195. It may have a fit.) In one embodiment, the bottom / floor of the compartment 240 may be semi-cylindrical or substantially arcuate and may substantially follow the substantially cylindrical shape of the auxiliary container 195. Thus, for example, the bottom / floor of compartment 240 can at least partially wrap around the auxiliary container 195.

[0212] For example, as shown in FIG. 31B, compartment 240 may have a partially rounded bottom / floor 241. The compartment 240 may be separated from the compartment 210 of the catheter introduction tray 200. For example, the catheter introduction tray 200 may include an overflow cavity 250 located between compartments 240 and 210. In one embodiment, the overflow cavity 250 may form a recess or recess between the compartment 210 and the compartment 240. For example, the overflow cavity 250 can prevent or limit the overflow of the disinfectant liquid dispensed into the compartment 210. In addition, the user can tap the swab 150 at or near the insertion site to drop excess disinfectant at the tip of the swab 150 into the overflow cavity 250.

[0213] The sloping bottom / floor 213 of the compartment 210 may rise above or be one step higher than the overflow cavity 250. For example, the sloping bottom / floor 213 has a fillet or radial structure 214 at its end that may extend downward from the sloping bottom / floor 213 toward the overflow cavity 250 or the overflow cavity 250 or its edges. You may have. Radial structure 214 can provide a transition between the sloping bottom / floor 213 and at least a portion of the overflow cavity 250 located below the sloping bottom / floor 213. In any case, the sloping bottom / floor 213 may be sloping downward along the direction away from the overflow cavity 250.

[0214] As mentioned above, the germicidal solution may be dispensed at the lowest portion 215 of compartment 210 (eg, at or near the lowest portion of the sloping bottom / floor 213). Further, the disinfectant liquid dispensed into the compartment 210 can generally flow toward and collect in the lowest portion 215 of the compartment 210. In addition, the tip 151 of the swab 150 may be placed or positioned in this disinfectant. Therefore, the user can remove the swab 150 from the compartment 210 and apply the disinfectant solution to the insertion site without any additional action.

[0215] The swab 150 may be secured in compartment 210 such that the tip (s) or absorbent head (s) 151 is placed in the disinfectant dispensed into compartment 210. .. For example, one, part or all of the swab 150 may include an elongated stem / rod 152 and a tip / absorbent head 151 attached to the stem / rod 152. Further, the compartment 210 may be provided with a groove 216 capable of accommodating and fixing the elongated stem / rod 152 of the swab 150. Therefore, the stem / rod 152 of the swab 150 can be fixed in the groove 216 of the compartment 210.

[0216] Groove 216 may include one or more holding structures (eg, detents, protrusions). In this holding structure, the stem / rod 152 may be fixed in the groove 216. For example, the stem 152 may have a substantially rectangular shape or a rectangular cross-sectional shape as a whole. When the stem / bar 152 is oriented along the long side of its rectangular cross-sectional shape, the holding structure may secure the elongated stem 152 within the groove 216. Further, by rotating or twisting the swab 150 in the groove 216 (eg, such that the short side of the rectangular cross-sectional shape of the stem 152 is oriented so that it is in the groove 216), the stem 152 is removed from the groove 216. It may be removed.

[0217] In other words, the spacing between the retaining structures of the grooves 216 may be smaller than the width of the long sides of the rectangular cross-sectional shape of the elongated stem 152. As a result, the holding structure can constrain the elongated stem / rod 152 into the groove 216. Further, the spacing between the holding structures may be greater than the length of the short side of the rectangular cross-sectional shape of the elongated stem / bar 152. Therefore, by twisting or rotating the swab 150 in the groove 216, the elongated stem / rod 152 can pass between the holding structures of the groove 216 in order to remove the elongated stem / rod 152 from the groove 216. ..

[0218] The catheter introduction tray 200 (and the catheter introduction trays shown in FIGS. 1-5) can be manufactured by any number of suitable methods and by any number of suitable manufacturing methods. As mentioned above, the catheter introduction tray (s) can be mass-produced by injection molding, thermoforming or other methods. For example, the catheter introduction tray (s) can be made from a sheet of plastic material, as described herein, and processed by compressing and heating the sheet to a suitable shape. obtain. Therefore, one or more of the sides of the catheter introduction tray (s) are relatively thin plastic materials (eg, 0.1 mm (0.005 inches), 0.3 mm (0.010 inches), 0. It may be provided with 5 mm (0.020 inch), 1.3 mm (0.050 inch), 2.5 mm (0.100 inch), etc.). As mentioned above, the catheter introduction tray (s) may be provided with reinforcing ribs on one or more sides thereof, the reinforcing ribs being able to provide rigidity to such sides.

[0219] The catheter introduction tray (s) are described herein in one or more partitions that divide the interior space of the catheter introduction tray (s) into the compartments described herein. It may be provided with reinforced ribs. Further, as described in detail below, the partition (eg, partition 221) may include a folded layer or a bilayer of the sheet material. Reinforcing ribs may project away from the compartments (eg, away from compartments 210, 220, 230) into the space between the sheet material layers.

[0220] As mentioned above, within these compartments, the internal corners and / or ridges formed between the bottom / floor and the inner wall, sides and / or partitions are provided with fillets or chamfers. May be good. For example, such fillets or chamfers can reduce stress at the internal corners or edges of these compartments. Thus, fillets and / or chamfers formed at the internal corners and / or ridges of these compartments can reduce or prevent breakage or breakage of the sheet material forming the catheter introduction tray 200.

[0221] The bottom / floor of compartment 230 may be substantially flat. In addition to, or instead, the bottom / floor of compartment 230 may have protrusions 232 and recesses 233. For example, the recess 233 may be lower than the protrusion 232 or may be farther from the protrusion 232 from the upper edge 206 of the catheter introduction tray 200. Further, the recess 233 may at least partially or completely surround the protrusion 232. So, for example, the recess 233 may accommodate at least a portion of the catheter that can surround the surface 232.

[0222] As described above, the catheter introduction tray 200 may be placed on a support surface, such as the surface of a patient's bed. For example, as shown in FIG. 31C, the recess 233 of the compartment 230 may form a protrusion on the outer surface of the catheter introduction tray 200, and the protrusion 232 may form a recess on the outer surface of the catheter introduction tray 200. May be good. Therefore, the outer surface of the recess 233 can provide or form a surface that can orient the catheter introduction tray 200 and / or support the catheter introduction tray 200 on the support surface. Further, in one embodiment, the outer surface of the recess 233 may be substantially parallel to the virtual plane of the upper edge 206.

[0223] Further, as described above, the groove 216 of the compartment 210 may be substantially parallel to the sloping bottom / floor 213 and may be sloping or non-parallel to the support surface. good. The orientation of the groove 216 of the compartment 210 may be non-parallel to the outer surface of the recess 233. For example, on the outer surface of the catheter introduction tray 200, the groove 216 may project outward from the sloping bottom / floor 213.

[0224] A compartment of the catheter introduction tray (eg, compartment 210) or a portion thereof may comprise a bactericidal or lavage fluid (eg, povidone iodine solution) therein. For example, at least a portion of the compartment may be provided with a disinfectant solution or may be sealed with a removable cover. Therefore, during the catheter introduction procedure, the user can avoid spilling the germicidal solution from the packet (eg, into the catheter introduction tray), which can prevent or reduce the spillage of the germicidal solution. can. The swab may be at least partially immersed in this disinfectant and / or may be at least partially sealed with a removable cover along with the disinfectant. Alternatively, or in addition, the swab may be placed in another compartment of the catheter introduction tray.

[0225] As mentioned above, the partition of the catheter introduction tray 200 may be formed by two layers of sheet material. At least some of those partitions may have spaces between their sheet material layers. For example, partition 221 may include first layer 221a and second layer 221b spaced apart from each other (eg, first layer 221a defines or forms the perimeter of compartment 230. The second layer 221b may demarcate or form the perimeter of the compartment 220.

[0226] The reinforcing rib 205 on the first layer 221a of the partition 221 projects outwardly into the space between the first layer 221a and the second layer 221b in a direction away from the compartment 230. May be good. The reinforcing rib 205 on the second layer 221b may also project outward toward the outer circumference or outer edge of the catheter introduction tray 200 in a direction away from the compartment 220. In any case, as described above, the compartment of the catheter introduction tray 200 may have a recess corresponding to the protrusion formed by the reinforced rib 205 on the outer surface portion of the catheter introduction tray 200.

[0227] The catheter introduction tray 200 may include one or more instructions or procedure indications that can assist the user during the catheter introduction procedure. For example, as shown in FIG. 32, the catheter introduction tray 200 may include indications 301-307. Indications 301 to 307 may be printed on the catheter introduction tray 200. For example, during the catheter introduction procedure, the first indication 301 may inform the user to open the package containing the germicidal solution, and the second indicator 302 uses pouring the germicidal solution into the compartment 210. You may inform the person.

[0228] The third indication 303 may inform the user to attach a syringe containing a liquid for inflating the catheter balloon to the catheter. In one embodiment, the fourth indication 304 may inform the user to dispense the lubricant and / or may identify or suggest a location within the compartment 220 to dispense the lubricant. good. In addition, indications 305-307 include additional or alternative steps performed during the catheter introduction procedure (eg, retracting the genitals (with the non-dominant hand), preparing the patient with a swab (with the dominant hand), and catheterizing the catheter. The step of inserting and inflating the balloon (with the dominant hand) may be identified.

[0229] To improve visibility, the catheter introduction tray 200 may include indications 301-307 printed using magnified letters or bold letters. Further, as shown in FIG. 32, another enlarged instruction / display may be printed on the bottom / floor of the compartment 230. The presence of labels 301-307 on the catheter introduction tray 200 can eliminate or reduce the need for printed brochures or similar instructions.

[0230] In one embodiment, as shown in FIG. 33, the catheter introduction system 100a may be equipped with one or more procedure indications 260a on the CSR sterile wrap 130a. Unless otherwise stated herein, the catheter introduction system 100a and its components and components are the catheter introduction system 100 (FIGS. 30A-32) and their respective components and components. It may be similar or the same. For example, the catheter introduction system 100a may include a catheter introduction tray 200 and the catheter introduction elements and / or components described above for the catheter introduction tray 200.

[0231] In one embodiment, the CSR sterile wrap 130a may include one or more procedure indications 260a that can assist the user during the catheter introduction procedure. For example, one or more of the procedure displays 260a may be individually isolated and / or individually separated or winged, or visually surrounded by a perimeter contour. In particular, by isolating each of the procedure displays 260a, the user's attention can be drawn, the user's attention can be focused on the procedure display, and the procedure display can be easily identified. The procedure display 260a may include information similar to or the same as that of the displays 301 to 307 (FIG. 32).

[0232] In one embodiment, the catheter introduction tray may include a windowed drape, which may partially cover the patient and facilitate catheter insertion. FIG. 34 shows a windowed drape 270. The windowed drape 270 may have a substantially rectangular shape. Further, the windowed drape 270 may include perforations 271. In particular, the perforations 271 may generally form a notch shape in the windowed drape 270, which is provided by tearing the portion of the windowed drape 270 separated by the perforations 271. It can be formed on the window drape 270. In one embodiment, the central portion of the windowed drape 270 is already open. That is, prior to packaging the windowed drape 270, the central material within the region enclosed by the perforations 271 has been removed.

[0233] The shape defined by the perforation 271 or the shape of the central opening is suitable for accessing the patient's reproductive organs for performing a catheterization procedure after covering the patient with a fenestrated drape 270. May be. Further, in some cases, the windowed drape 270 may include a side notch 272. For example, the side notch 272 may be substantially V-shaped. In one embodiment, the side notch 272 facilitates placement of the windowed drape 270 near the patient's leg.

[0234] As mentioned above, the catheter introduction system can facilitate the sterilization of various components that can facilitate the catheter introduction procedure (eg, areas near or at the catheter introduction site). It may be equipped with a swab). FIG. 35 shows the swab 150. For example, the swab 150 may include an elongated member or stem / rod 152 with a tip / absorbent head 151 attached thereto.

[0235] The tip / absorbent head 151 is generally rounded with an outer or distal portion and tapered (eg, tapering towards the proximal end of the tip / absorbent head 151 and the elongated stem / rod 152). It may have a proximal portion. For example, the tip / absorbable head 151 may be thinner than the distal portion at the proximal end (ie, the distal portion may be funnel-shaped throughout and its anterior end rounded throughout. May be).

[0236] The tip / absorbent head 151 may contain any suitable material, which can be varied from embodiment to embodiment. The tip / absorbent head 151 may include or include a liquid absorbent material. This liquid absorbing material is capable of absorbing the bactericidal solution and subsequently distributing the bactericidal solution at and / or near the catheter introduction site. For example, the tip / absorbent head 151 may be equipped with a suitable foam, sponge, cotton, or the like.

[0237] The tip / absorbent head 151 may be attached to the elongated stem / rod 152 by any number of suitable mechanisms. This mechanism can be changed for each embodiment. For example, the tip / absorbent head 151 may be attached to the elongated stem / rod 152 by adhesive, ultrasonic welding, or the like. The elongated stem 152 may be inserted to a predetermined depth within the tip / absorbent head 151, which allows the tip / absorbent head 151 and the elongated stem / rod 152 to be appropriately fixed as a unit and at the same time. (For example, avoiding the patient's contact with the elongated stem / rod 152 while applying the bactericide to the insertion site and / or avoiding injury or injury to the patient by the elongated stem / rod 152. It can be facilitated to leave a sufficient portion of the tip / absorbent head 151 in front of the elongated stem / rod 152). For example, after being secured to an elongated stem / rod 152, the tip / absorbent head 151 can have sufficient flexibility, sufficient elasticity and / or rigidity so that the tip absorbs the germicidal solution. After that, it does not bend substantially and can bend elastically while applying the bactericidal solution to the insertion site.

[0238] As mentioned above, in some examples, the catheter assembly within the catheter introduction tray may be oriented substantially parallel to the support surface supporting the catheter introduction tray. The catheter assembly in the catheter introduction tray may be oriented approximately perpendicular or orthogonal to the support surface. 36A-36B show a catheter introduction system 100a including a catheter introduction tray 200a. The catheter introduction tray 200a secures the catheter assembly and / or one or more components or elements for the catheter introduction procedure. Except as described herein, the catheter introduction system 100a and its components and components may be similar or identical to the catheter introduction system 100 (FIG. 30A) and its elements or components. For example, except as described herein, the catheter introduction tray 200a and the catheter introduction elements and components housed in the catheter introduction tray 200a are the catheter introduction tray 200 (FIGS. 31A-32) and the catheter introduction tray 200a thereof. It may be similar to the catheter introduction element or component contained.

[0239] For example, as shown in FIG. 36A, the catheter introduction tray 200a may have a substantially rectangular shape, which may be formed by the side surfaces 201a-204a. The sides 201a-204a may be substantially flat and thus may form a box-like structure or perimeter of the catheter introduction tray 200a. The catheter introduction tray 200a may further include a top compartment 210a capable of comprising instructions and / or one or more catheter introduction components. In one embodiment, the top compartment 210a may be formed by partitions 211a, 212a and bottom 213a. In one embodiment, the partitions 211a, 212a and / or the bottom 213a may be removable from the catheter introduction tray 200a.

[0240] In one embodiment, removal of partitions 211a, 212a and / or bottom 213a may provide access to additional catheter introduction components contained within the catheter introduction tray 200a. For example, as shown in FIG. 36B, after removing partitions 211a, 212a and bottom 213a (FIG. 36A), the central compartment 220a of the catheter introduction tray 200a can be exposed and / or to the user. On the other hand, it can be made accessible. For example, compartment 220a may contain or comprise catheter assembly 190. In one embodiment, partition 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 is oriented so that it is approximately perpendicular to the support surface (eg, when the catheter introduction tray 200a is placed on the support surface, such as the surface of the patient's bed). May be done.

[0241] In one embodiment, the partitions 221a, 222a may separate the central compartment 220a from the adjacent compartments 230a, 240a. The compartments 230a and / or 240a may contain or comprise various catheter introduction elements or components for the procedure. Those catheter introduction components or components may be similar to or identical to the catheter introduction components described above for the catheter introduction tray 200 (FIGS. 31A-32). In some cases, the partitions 221 and / or 222a may be removable from the catheter introduction tray 200a, which facilitates removal of the catheter introduction element or component from the catheter introduction tray 200a. be able to.

[0242] The catheter introduction tray 200a can be constructed from any suitable material. For example, the catheter introduction tray 200a may be constructed from a thick sheet-like material or panel (eg, plastic material). For example, the thickness of those panels may be within one or more of the following ranges: From about 2.5 mm (about 0.1 inch) to about 5.1 mm (about 0.2 inch), from about 3.8 mm (about 0.15 inch) to about 7.6 mm (about 0.3 inch), about 6 From 0.4 mm (about 0.25 inch) to about 12.7 mm (about 0.5 inch). However, it should be understood that the thickness of the panel may be less than 2.5 mm (0.1 inch) or greater than 12.7 mm (0.5 inch). In addition, the catheter introduction tray 200a may be reused after the catheter introduction procedure (eg, the catheter introduction tray 200a may be sterilized and / or repackaged for reuse).

[0243] In one embodiment, the catheter introduction tray (eg, in addition to or in lieu of removing the partition) may be at least partially disassembled. FIG. 37A shows a catheter introduction system 100b that may include a catheter introduction tray 200b, the catheter introduction tray 200b being expandable to access the contents therein. As mentioned above, the catheter introduction system 100b may include a catheter introduction tray 200b that can be wrapped with a CSR sterile wrap 130b, which may be opened to access the catheter introduction tray 200b. For example, initially, the flap or portion 131b of the CSR sterile wrap 130b may be unfolded towards the patient (eg, thereby covering the support surface with the sterile portion 131b of the CSR sterile wrap 130b).

[0244] In one embodiment, the CSR sterile wrap 130b may comprise a pocket 132b, even if the pocket 132b is exposed when the CSR sterile wrap 130b is opened to expose the catheter introduction tray 200b. good. In one embodiment, used items or debris may be placed in pocket 132b during and / or after the catheter introduction procedure. Subsequently, this waste may be discarded together with the CSR sterile wrap 130b.

[0245] The drape (eg, windowed drape 270) is a CSR so that the drape is exposed after the CSR sterile wrap 130b is opened and the drape can be removed from the CSR sterile wrap 130b and used in the catheter introduction procedure. It may be attached to a sterile wrap 130b. In one embodiment, the windowed drape 270 may be attached to the CSR sterile wrap 130b by any suitable means, which means can be varied for each embodiment. In one example, the windowed drape 270 may be attached to the CSR sterile wrap 130b with a weak adhesive, tape, tabs, or the like.

[0246] As mentioned above, the catheter introduction tray 200b can be exposed after opening the CSR sterile wrap 130b. The catheter introduction tray 200b may comprise one or more identifiers 260b, which identifier 260b may identify or suggest the order of steps in the catheter introduction procedure and / or the order of use of the catheter introduction component. May (eg, their identifiers may be on one or more outer surfaces of the catheter introduction tray 200b). For example, the identifier 260b may be located on the top surface of the catheter introduction tray 200b and may indicate the subsequent steps of the catheter introduction procedure. According to one embodiment, the top panel 201b of the catheter introduction tray 200b may be opened to unfold the catheter introduction tray 200b to access the catheter introduction component within the catheter introduction tray 200b.

[0247] As shown in FIG. 37B, after opening the catheter introduction tray 200b, the user can access the compartment 210b, which comprises the catheter assembly 190 for the catheter introduction procedure. May be good. For example, the top panel 201b can be extended away from the panels 203b, 204b, 205b together with the side panel 202b (connected to the top panel 201b). More specifically, the side panels 203b, 204b and the reinforced rib 205b may partially form the outer edge of the compartment 210b. When the side panel 202b and the top panel 201b are extended from the side panels 203b, 204b, 205b, the compartment 210b is accessed through the side surface (where the side panel 202b is extended from) and the top surface (where the top panel 201b is removed). be able to. In one embodiment, the side panel 202b and the top panel 201b may be extended in a direction generally opposite to the insertion site or away from the insertion site (eg, in a manner that does not appear to interfere with the catheter introduction procedure). ..

[0248] Further, the catheter introduction tray 200b may include additional or alternative catheter introduction components (eg, syringe 170, swab 150) on the inner surface of the panel 201b. Such catheter introduction components may be attached or secured to the top panel 201b and / or the side panel 202b. For example, the syringe 170 may be secured to the top panel 201b using one or several straps 220b. Further, in some cases, the swab 150 may be secured to the top panel 201b within one or more pockets 230b. Can the catheter introduction component (eg, syringe 170, swab 150, etc.) be attached to the top panel 201b by any number of suitable mechanisms (eg, adhesive, tab, etc.) in any number of suitable ways? It should be understood that it may be fixed. In any case, the catheter introduction component anchored to the inner surface of the top panel 201b and / or the side panel 202b is accessible and removable after being unfolded away from the side panels 203b, 204b, 205b. There may be.

[00249] Further, the side panel 202b and / or the top panel 201b may include one or more procedure indications 260b near the corresponding one or more catheter introduction components. For example, the procedure display 260b may identify the catheter introduction component by number, even if this number corresponds to the proposed process number of the proposed sequence of steps for the catheter introduction procedure. good. In addition, the catheter introduction component and the corresponding procedure indication 260b may be arranged in sequence such that the indication with the higher number and the corresponding catheter introduction component are generally located farther from the insertion site. In other words, the catheter introduction component used relatively earlier in the catheter introduction procedure (based on the orientation of the catheter introduction tray 200b) may be closer to the insertion site, while the catheter introduction procedure. The catheter introduction component used relatively later is located farther from the insertion site.

[00250] In one embodiment, the catheter introduction tray 200b may include a horizontal panel 207b, which may be connected to the side panel 204b and extend from the side panel 204b (eg,). , The horizontal panel 207b may be folded into the compartment 210b and / or may be substantially parallel to the support surface supporting the catheter introduction tray 200b). In some cases, the horizontal panel 207b may support and / or immobilize one or more catheter introduction components. For example, the horizontal panel 207b may secure the pouch 180b containing the lubricant, and the pouch 180b may be removed from the horizontal panel 207b and used in the catheter introduction procedure.

[00251] In one embodiment, the side panels 204b and the horizontal panel 207b may be extended away from the side panels 203b, 205b, as shown in FIG. 37C. For example, the side panel 204b can be expanded to access the compartment 210b. Further, one or more catheter introduction components may be attached to the inside of the side panel 204b and / or the horizontal panel 207b at the inner surface thereof. For example, the fungicide packet 160 may be attached to the horizontal panel 207b and / or the side panel 204b (eg, with a weak adhesive). In addition, the catheter introduction tray 200b may include a display 260b that identifies the steps or specific order or location in which the disinfectant packet 160 in the sequence of catheter introduction procedures may be used.

[00252] As mentioned above, the catheter introduction system may include a catheter introduction tray wrapped in sterile wrap, which may be used during the catheter introduction procedure. The catheter introduction system may include one or more catheter introduction components packaged by a sterile wrap and / or secured within the sterile wrap (eg, directly in the sterile wrap without a catheter introduction tray). .. Such a catheter introduction system can reduce the amount of waste or material discarded after the catheter introduction procedure. For example, after completing the catheter introduction material, the sterile wrap can be discarded and / or composted to reduce long-term waste from the catheter introduction system.

[0253] Following those previously described, FIGS. 38A, 39A, 40A, 41A, 42A, and 43A are for a medical procedure package with some alternative embodiments to the previously described medical procedure trays. A medical procedure tray (eg, a catheter introduction tray for a catheter introduction package) is provided. For explanatory convenience, the features of the alternative embodiments shared with the medical procedure trays previously described in detail above are not described in the same details below. It should be understood that the description of each of the shared features will be incorporated by reference, if necessary, by the name of the shared features when describing the alternative embodiments. For additional explanatory convenience, not all features of the alternative embodiments shared with the previously described medical procedure trays are further described. Instead, the shared visual elements between the alternative embodiment and the previously described medical procedure tray are shared between the alternative embodiment and the previously described medical procedure tray. It should be understood that it expresses a characteristic. Accordingly, the shared visual elements provide a basis for, if necessary, to incorporate by reference an explanation for each of the shared features of the alternative embodiment. For example, FIGS. 2 and 38A provide a medical procedure tray containing reinforced ribs. (See Reinforced Rib 20 in FIG. 2 and its Description.) Reinforced ribs in the alternative embodiment of FIG. 38A are not explicitly described, but the description of the reinforced ribs is a shared visual representation of the reinforced ribs. Incorporated by reference taking into account the elements.

[0254] FIG. 38A shows a diagram of another medical procedure tray 3800 with some embodiments. FIG. 38B shows another view of the medical procedure tray 3800 of FIG. 38A. FIG. 38C shows another view of the medical procedure tray 3800 of FIG. 38A along with the cover 3801. FIG. 38D shows another view of the medical procedure tray 3801 of FIG. 38A along with the cover 3801.

[0255] The medical procedure tray 3800 of FIGS. 38A, 38B, 38C, and 38D can include a first section 3810, a second section 3820, and a third section 3830. As described herein, sections of the medical procedure tray can be designated for one or more specific uses (eg, wells for iodine, sections for storage, etc.). , Sections are separated from one or more other sections, at least partially and completely, by one or more physical features (eg, one or more partitions), thereby 1 Partitions for one or more specific uses can be formed. As shown, the medical procedure tray 3800 includes a first partition 3842 formed from the medical procedure tray 3800 itself. The surface of the first partition 3842, or at least the first partition 3842, facing the first section (see FIG. 38A) is at the end of the medical procedure tray 3800 containing at least the second section 3820. It has a first height h ₁ equal to the height of the tray 3800. The surface facing the first section of the first partition 3842, or at least the first partition 3842 (see FIG. 38A), is at least at the end of the medical procedure tray 3800 opposite the second section 3820. It has a second height h ₂ that is smaller than the first height. Considering the first partition 3842, consider the first section 3810 to be a first section 3810 that is at least partially separated from the third section 3830 and completely separated from the second section 3820. Can be done. As further shown, the medical procedure tray 3800 includes a second partition 3844 formed from the medical procedure tray 3800 itself. The second partition 3844, or at least the surface of the second partition 3844 facing the third section (see Figure 38A or 38B), has a first height equal to the height of the medical procedure tray 3800. Considering the first partition 3842 and the second partition 3844, the second section 3820 can be considered as a second section 3820 completely separated from the first section 3810 and the third section 3830. can. Further considering the first partition 3842 and the second partition 3844, the third section 3830 is at least partially separated from the first section 3810 and completely separated from the second section 3820. It can be thought of as a partition 3830.

[0256] Similar to the medical procedure tray previously described, the medical procedure tray 3800 may include medical procedure instructions imprinted directly on the medical procedure tray 3800, at least a portion of the instructions. It can be exposed for each step of the medical procedure. When the medical procedure tray 3800 is incorporated into the medical procedure package together with the contents for the medical procedure (eg, a drainage system including a catheter for a catheter introduction procedure, a container for lubricants, a syringe of water, a skin preparation kit, etc.). In addition, the gradual removal of the contents can expose the gradual instructions for the medical procedure imprinted on the medical procedure tray 3800.

[0257] With respect to the first section or section 3810, the first section 3810 can be configured to accommodate a first set of contents for medical procedures. In some embodiments, the medical procedure is a catheter introduction procedure, wherein the first set of contents includes, but is not limited to, a catheter (eg, a Foley catheter), a drainage tube, and a drainage bag. Can be included. The first set of contents can further include a syringe of sterile water for inflating a balloon, such as a Foley catheter balloon. When the medical procedure tray 3800 is incorporated in the medical procedure package, the first section 3810 can include a first set of contents. For visual reference, the medical procedure trays 3800 of FIGS. 38A, 38B, 38C, and 38D are shown with a sterile water syringe 3892. As shown in FIGS. 38A and 38B, the sterile water syringe 3892 is simply placed along the inner wall of the medical procedure tray 3800, or loose fit tightening at both ends of the sterile water syringe 3892. It can be fitted in an appropriate position along the inner wall with a loose-fit syringe fit. As shown in FIGS. 38C and 38D, the sterile water syringe 3892 can still be placed along the inner wall of the medical procedure tray 3800. However, the sterile water syringe 3892 can also be placed in the folded portion of the cover 3801 or in the retainer 3803.

[0258] With reference to FIGS. 38C and 38D, the medical procedure tray 3800 is a cover 3801 such as the packaging label 62 described in connection with FIGS. 11 and 12, and an identification cover described in connection with FIG. 30A. Shown with 120, or a combination thereof. As further indicated, the cover 3801 can be folded to form a retainer 3803 for keeping certain contents of the medical procedure package within the first section 3810. For example, the retainer 3803 may be configured to maintain the sterile water syringe 3892 in the first section 3810 away from certain other contents of the medical procedure package in the first section 3810. Can be done. Other parts of the cover 3801 can be folded to form other retainers to keep the contents of the medical procedure package in the appropriate section. As shown, the cover 3801 can be configured to fit within the first section 3810 of the medical procedure tray 3800. However, the cover 3801 may optionally fit within the first section 3810 and additional sections of the medical procedure tray 3800 or a portion thereof (eg, second section 3820, third section 3830, etc.). Can be configured in. The cover 3801 is an alternative, except for the folded or otherwise formed portion of the cover 3801 that forms a retainer to keep the contents of the medical procedure package in the appropriate section. The entire procedure tray 4100 can be configured to fit above the medical procedure tray 4100 by any of the above configurations.

[0259] With respect to the second section or section 3820, the second section 3820 can be configured to accommodate a second set of contents for medical procedures. In some embodiments, the medical procedure is a catheter introduction procedure and the second set of contents includes, but is not limited to, a container containing a lubricant (eg, a lubricant for a Foley catheter). Can be done. When the medical procedure tray 3800 is incorporated into the medical procedure package, the second section 3820 can include a second set of contents. For visual reference, the medical procedure tray 3800 of FIGS. 38A and 38B is shown with a lubricant container 3894.

[0260] As far as the configuration of the second section or compartment 3820 for the second set of contents is concerned, the second section 3820 provides open access for easy retrieval of the second set of contents. While being provided at the same time, it can be configured as a retainer for retaining or otherwise fixing a second set of contents (eg, a container of lubricant 3894). The second partition 3844 formed from the medical procedure tray 3800 has a first height previously described (eg, the height of the medical procedure tray 3800) in a plane facing the third section of the second partition 3844. Can have (see Figure 38A or 38B). However, the second partition 3844 can further have a second height in the plane facing the second section of the second partition 3844. The second height of the second partition 3844 facing the second section can be smaller than the first height of the second partition 3844 facing the third section, and , It serves to lift the bottom 3822 of the second section 3820 above the bottom 3812 of the first section 3810 or tray 3800 (see Figure 38B). Again, for visual reference, the medical procedure tray 3800 of FIGS. 38A and 38B is shown with the lubricant container 3894. The lubricant container 3894 is shared with the second section 3820 on both sides of the lubricant container 3894, at both ends of the lubricant container 3894, or in a combination thereof, with a loose fit clamp. Procedure Can be properly positioned along the inner wall (or protrusion thereof) of the tray 3800 and the surface of the second partition 3844 facing the second section. The bottom 3822 of the second section 3820, lifted above the bottom 3812 of the first section 3810 or tray 3800, provides open access for easy retrieval of a second set of contents.

[0261] With respect to the third section or section 3830, the third section 3830 can be configured to accommodate a third set of contents for medical procedures. In some embodiments, the medical procedure is a catheter introduction procedure, the third set of contents is not limited to the sample container, optionally a label for the sample container, as well as a disinfectant. A skin preparation kit containing a packet (eg, iodine fore such as povidone iodine, iodine tincture, water soluble iodine, etc.) and one or more swabs can be included. When the medical procedure tray 3800 is incorporated into the medical procedure package, the third section 3830 can include a third set of contents. The medical procedure tray 3800 of FIGS. 38A and 38B is shown without a sample container or skin preparation kit. However, FIGS. 8, 26, and 27 provide a visual reference for including one or more swabs 34 in the medical procedure tray 3800, and FIGS. 25-29 are in the medical procedure tray 3800. Provides a visual reference for including the specimen container 54, and FIG. 25 provides a visual reference for including a packet of the disinfectant 52 in the medical procedure tray 3800.

[0262] As far as the configuration of the third section or section 3830 for the third set of contents is concerned, the third section 3830 shall be configured with one or more additional subsections or subsections. Can be done. As shown in FIGS. 38A and 38B, one or more additional subsections or subsections can include swab compartments 3832, overflow compartments 3834, and square storage compartments 3836. Swab compartment 3832 can then include wells 3831 and one or more grooves, one of which is designated as groove 3833. Well 3831 can be placed at the base of the second partition 3844, which separates the second section 3820 from the third section 3830 as shown in FIGS. 38A and 38B. do. Wells 3831 can be further placed on the base of one or more grooves, thereby joining the respective grooves of one or more grooves at the well ends. Wells 3831 can be configured to contain fluids such as disinfectants in medical procedure packages when poured into them.

[0263] One or more grooves can be configured to hold one or more swabs of the skin preparation kit for subsequent use with the disinfectant in a packet of disinfectant. Each groove in one or more grooves is optionally under one or more snap-fit structures or snap-fit tabs arranged along the length or longitudinal side of the groove. Can be configured to hold each swab of. Any two or more snap-fit tabs arranged along the length or longitudinal side of the groove, eg, any three or more snap-fit tabs, and, for example, any four or more snap-fit tabs. Tabs and the like can be staggered with respect to each other. As shown between FIGS. 38A and 38B, each groove of one or more grooves can include three staggered snap-fit tabs along its longitudinal side. .. (See also FIG. 8 and the description thereof.) Each groove of one or more grooves can be further configured with an inclination or angle with respect to the bottom 3812 of the tray 3800. Moreover, each groove of the one or more grooves can be configured in a delta or delta shape at the well end adjacent to the well 3831. With such a configuration, the handle end of the swab, which is held under the snap-fit tab of the groove, is the absorbent head end of the swab when the absorbent head end is placed in the containment delta for it. Can be lifted against. As such, the swab's absorbent head can be angled downward into the well 3831 of the swab compartment 3832 of the third section 3830, and the elongated member of the swab can be medically provided, including the tray 3800 and the swab. Procedure In the appropriate process of unboxing the package, it can be angled upwards for gripping and removal.

[0264] The overflow compartment 3834 can be located at the end of one or more grooves on the opposite side of the well 3831. The overflow compartment 3834 can be fluid connected to the well 3831 through one or more grooves, each of which is a fluid along its length as the fluid is poured into or over it. For example, it can be further configured to carry a skin preparation kit disinfectant). If the medical procedure requires additional disinfectant, such as for skin preparation, additional disinfectant can be safely added to the well 3831 and the total volume of the swab compartment 3832 (eg, for example). It ensures that any volume of disinfectant (well 3831 and the combined volume of one or more grooves) can be spilled into the overflow compartment 3834 through one or more grooves.

[0265] With respect to the corner storage compartment 3836, the corner storage can be located between the overflow compartment 3834 and the inner wall of the tray 3800, thereby sharing the inner wall of the tray 3800. The square storage compartment 3836 can be configured to accommodate the sample container of the medical procedure package. Moreover, the medical procedure package can include a packet of disinfectant in or above the swab compartment 3832 and the overflow compartment 3834, as shown in FIG. It can be further configured to contain at least a portion of the packet. In such a configuration, the disinfectant packet can be placed in or above the swab compartment 3832, the overflow compartment 3834, the corner storage compartment 3836, or a combination thereof, within the medical procedure package containing the tray 3800.

[0266] FIG. 39A shows a diagram of another medical procedure tray 3900 with some embodiments. FIG. 39B shows another diagram of the medical procedure tray 3900 of FIG. 39A.

[0267] The medical procedure tray 3900A of FIGS. 39A and 39B can have a configuration similar to the medical procedure tray 3800 described with reference to FIGS. 38A, 38B, 38C, and 38D. Therefore, the tray 3900A can also include a first section or a first section 3910, a second section or a second section 3920, and a third section or a third section 3930, respectively. Can be configured to contain and retain the contents for medical procedures. However, as shown, the first section 3910 of the tray 3900A can have a different configuration than the first section 3810 of the tray 3800. For example, the first section 3810 of the tray 3800 of FIGS. 38A, 38B, 38C, and 38D has a more square footprint, while the first section 3910 of the tray 3900A of FIGS. 39A and 39B is more. It has a rectangular footprint. This is the same as the side of the tray 3900A around the first section 3910 (eg, the side of the tray 3900A adjacent to the syringe 3892 for sterile water and the opposite side) of the tray 3800 around the first section 3810. The result is that it is longer than the sides of. This configuration of the first section 3910 allows for a relatively large capacity for a relatively large number of contents of the medical procedure package containing the tray 3900A.

[0268] Not only can 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 may be one or more of the tray 3800. It can have a different configuration than a plurality of partitions. Although not shown in FIGS. 39A and 39B, a different configuration is one or more partitions of the tray 3800, the one or more partitions having a height equal to the height of the tray (eg, maximum height). Can include non-proportional or proportionally lower heights with respect to one or more partitions of tray 3900A. For an example of non-proportional low height, the first partition 3942 of tray 3900A can have a lower height less proportional than the first partition 3842 of tray 3800, similar to the first partition 3942. The first height h _{1 can be lower than the first height h 1 of} the first partition 3842, and a similar second height h ₂ of the first partition 3942 is the first. It can be substantially the same as the second height h ₂ of partition 3842. FIG. 41B provides a visual reference for such non-proportional low heights with respect to the first partition 3942 as compared to the first partition 3842, with the first partition 3942 of tray 3900A being shown in FIGS. 39A and With the understanding that it continues to the inner wall of tray 3900A, as shown in 39B. For an example of a proportionally lower height, the second partition 3944 of the tray 3900A can have a height proportionally lower than the second partition 3844 of the tray 3800. Also, FIG. 41B provides a visual reference for such a proportionally lower height for the second partition 3944 as compared to the second partition 3844. Configuring the one or more partitions of the tray 3900A so that the height is not or proportionally lower than the one or more partitions of the tray 3800 is still the lubricant container 3894. Allows the bottom of the second section 3920 to be lower than the bottom 3822 of the second section 3820 of the tray 3800, while providing open access for easy retrieval. For example, the bottom of the second section 3920 can be substantially coplanar with the bottom of the first section 3910 or the bottom of the tray 3900A. Again, FIG. 41B provides a visual reference for such a bottom of the second section 3920 of the tray 3900A, the first partition 3942 of the tray 3900A is shown in FIGS. 39A and 39B. As such, with the understanding that it continues to the inner wall of tray 3900A. The coplanar bottom embodiment of the second section 3920 of the tray 3900A and the lifted bottom 3822 embodiment of the tray 3800 both embodiments are housed too deep in the second section well. It provides open access for easy removal of the lubricant container 3894 in that it does not have a lubricated container 3894.

[0269] In the embodiment, the bottom of the raised second section of the tray (eg, the raised bottom 3822 of the second section 3820 of the tray 3800) and the second section coplanar with the bottom of the tray. Disclosed with respect to the bottom (eg, the bottom in the same plane as the second section 3920 of the tray 3900A), the bottom of any compartment of any medical procedure tray disclosed herein is the tray 3800 and It should be understood that the height from the bottom of the tray can vary according to what is described for the 3900A.

[0270] FIG. 39C shows a diagram of a medical procedure tray 3900B comprising a plurality of retainers in a first configuration according to some embodiments.

[0271] The medical procedure tray 3900B of FIG. 39C can have the same configuration as the medical procedure tray 3900A described with reference to FIGS. 39A and 39B. As such, tray 3900B can likewise include a first section 3910, a second section 3920, and a third section 3930, each of which is to contain and hold contents for medical procedures. Can be configured in. However, as shown, the first section 3910 of tray 3900B can have a different configuration than the first section 3910 of tray 3900A. For example, the first section 3910 of tray 3900B in FIG. 39C can have multiple retainers, one of which is shown as retainer 3912. In contrast, the first section 3910 of tray 3900A in FIGS. 39A and 39B is shown without multiple retainers. However, it is understood that the tray 3900A, and any tray provided herein, may optionally include one or more retainers of any type provided herein. Should be. The plurality of retainers in the first section 3910 of the tray 3900B can be configured to retain certain contents of the medical procedure package in the first section 3910. For example, the retainers are configured to keep the sterile water syringe 3892 in the first section 3910 away from certain other contents of the medical procedure package in the first section 3910. be able to. One of several different types of retainers (eg, column-type or tapered column-type retainers, rack-type retainers, tab-type retainers, removable retainers, etc.) can be formed, and multiple retainers can be formed. Any (eg, one, two, three, four, or five, or more retainers) can be formed, some of which are formed from the tray 3900B itself. be able to. As shown, in FIG. 39C, the first section 3910 of tray 3900B comprises at least three tapered column type retainers equidistant from the sides of tray 3900B adjacent to the sterile water syringe 3892. Can be done.

[0272] FIG. 39D shows a diagram of a medical procedure tray 3900C comprising a plurality of retainers in a second configuration according to some embodiments.

[0273] The medical procedure tray 3900C of FIG. 39D can have the same configuration as the medical procedure tray 3900B described with reference to FIG. 39C. Therefore, the tray 3900C can also include a first section 3910, a second section 3920, and a third section 3930, each of which accommodates and holds the contents for a medical procedure. Can be configured in. However, as shown, the first section 3910 of the tray 3900C can have a different configuration than the first section 3910 of the tray 3900B. For example, the first section 3910 of tray 3900C in FIG. 39D can also have at least three tapered column type retainers, one of which is designated as retainer 3912, of which. Another retainer is shown as retainer 3913. However, at least one retainer of at least three tapered column type retainers of the tray 3900C, as opposed to at least three tapered column type retainers equidistant from the sides of the tray 3900B. For example, the retainer 3913) can be offset from others, as indicated by the dotted line. Such different configurations can further limit the degree of freedom of certain contents of the medical procedure package in the first section 3910 (eg, sterile water syringe 3892). Therefore, such a different configuration separates certain other contents of the medical procedure package in the first section 3910 and further separates such certain contents in the first section 3910. Can be maintained.

[0274] FIG. 40A shows a diagram of another medical procedure tray 4000 with some embodiments. FIG. 40B shows another diagram of the medical procedure tray 4000 of FIG. 40A.

[0275] The medical procedure tray 4000 of FIGS. 40A and 40B can have the same configuration as the medical procedure tray 3900A described with reference to FIGS. 39A and 39B. Therefore, the tray 4000 can also include a first section or a first section 4010, a second section or a second section 4020, and a third section or a third section 4030, respectively. Can be configured to contain and retain the contents for medical procedures. However, as shown, the second section 4020 of tray 4000 can have a different configuration than the second section 3920 of tray 3900A. For example, the second section 4020 of tray 4000 can be an extended section extending into the first section 4010, while the second section 3920 of tray 3900A is the second section of tray 3900A. It terminates in a common partition for both Section 3920 and Section 3930, i.e., in the first partition 3942. The extended second section 4020 of the tray 4000 can be formed from the extended second partition 4044, and the extended second partition 4044 extends into the first section 4010. , Terminate at the third partition 4046 in the first section 4010 of tray 4000. In addition, the first partition 4042, which separates the third section 4030 from the first section 4010, terminates at the middle portion of the extended second partition 4044 instead of terminating at the inner wall of the tray 4000. be able to. By configuring the second section 4020 as an extended section, the extended second section 4020 has more content, larger content, as needed for medical procedures. Or both can be accommodated. As shown, the extended second section 4020 contains a larger lubricant container 4094 compared to the lubricant container 3894 shown in FIGS. 39A and 39B.

[0276] FIG. 41A shows a diagram of another medical procedure tray 4100 according to some embodiments. 41B shows another diagram of the medical procedure tray 4100 of FIG. 41A. 41C shows a third diagram of the medical procedure tray 4100 of FIG. 41A.

[0277] The medical procedure tray 4100 of FIGS. 41A, 41B, and 41C can include a first section 4110, a second section 4120, and a third section 4130, each of which is for a medical procedure. It can be configured to contain and hold the contents. As described herein, sections of medical procedure trays can be designated for one or more specific uses, where sections are one or more physical features (eg, for example). It is separated from one or more other sections by (eg, one or more partitions) at least partially (eg, second section 4120) and entirely (eg, third section 4130). Allows you to form one or more compartments for a particular use. As shown, tray 4100 includes a first partition 4142 and a second partition 4144 that completely separate the third section 4130 from the first section 4110 and the second section 4120. In addition, the second partition 4144 partially separates the second section 4120 from the first section 4110. Similar to the medical procedure tray 3800 of FIGS. 38A and 38B, the first partition 4142 (or at least the surface of the first partition 4142 facing the first section) of the tray 4100 has a first height h ₁ and It can have a second height h ₂ (see FIG. 41B), where the second partition 4144 (or at least the surface of the second partition 4144 facing the third section) has a 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, as shown, of the medical procedure tray 4100. Less than height. In addition, the surface of the second partition 4144 facing the second section can have a height equal to the height of the surface of the second partition 4144 facing the third section, the second section. The bottom of the 4120 can be coplanar with the bottom of the first section 4110 or tray 4100. (See FIG. 41B.)

[0278] With respect to the first section 4110 of the tray 4100, the first section 4110 can be configured to accommodate a first set of contents for a medical procedure such as a catheter introduction procedure. As previously described, the first set of contents is not limited to, but is limited to, catheters (eg, Foley catheters), drainage tubes, drainage bags, and syringes of sterile water for inflating Foley catheter balloons. A drainage system can be included, including 3892. For visual reference, the sterile water syringe 3892 is a first type different from the retainers described with reference to trays 3900B and 3900C of FIGS. 39C and 39D, respectively (eg, tapered column type retainers). It is shown to be mounted in or on a retainer in section 4110 (eg, a rack-type retainer). Similar to the multiple retainers for trays 3900B and 3900C, the retainer for the sterile water syringe 3892 can be formed from the tray 4100 itself, and the other contents of the medical procedure package in the first section 4110. It can be configured to keep the sterile water syringe 3892 in the first section 4110 away from the object. The sterile water syringe 3892 can simply be placed in a retainer or rack, or the sterile water syringe 3892 can be placed in a retainer or rack by a loose fit clamp around the sterile water syringe 3892. Can fit in.

[0279] With respect to the second section 4120 of tray 4100, the second section 4120 can be configured to accommodate a second set of contents for medical procedures such as catheter introduction procedures. As previously described, the second set of contents includes, but is not limited to, a container containing a lubricant (eg, a lubricant for a Foley catheter), such as a lubricant syringe 4194. Can be done. For visual reference, the lubricant syringe 4194 is a retainer 4114 similar to that described with reference to the retainer in the first section 4110 for the sterile water syringe 3892 (eg, rack type). It is shown to be mounted in or on the retainer). The lubricant syringe 4194 can simply be placed in a retainer or rack 4194, or the lubricant syringe 4194 can be a retainer or rack 4194 by a loose fit clasp around the lubricant syringe 4194. Can fit inside.

[0280] The retainer for the retainer 4194 and the sterile water syringe 3892 is the same as or required by the size of the lubricant syringe 4194 and the size of the sterile water syringe 3892 required by the medical procedure. Can have different dimensions. When the size of the lubricant syringe 4194 and the size of the sterile water syringe 3892 are the same, the retainer or rack for them can have the same dimensions, the lubricant syringe 4194 and the sterile water syringe 3892. Can be replaced with respect to their installation of medical procedure packages, for example, to better coordinate the steps of the medical procedure. Thus, the second section 4120 is not limited to accommodating and retaining the lubricant syringe 4194, and the first section 4110 is not limited to accommodating and retaining the sterile water syringe 3892. The second section 4120 can be configured to accommodate and hold the sterile water syringe 3892, even if the size of the lubricant syringe 4194 and the size of the sterile water syringe 3892 are different, the first section 4110. Can be configured to accommodate a lubricant syringe 4194.

[0281] With respect to a third section 4130, the third section 4130 houses a third set of contents for a medical procedure, such as a catheter introduction procedure, as described herein. Includes a swab compartment 4132, an overflow compartment 4134, and a corner storage compartment 4136, configured as such. As previously described, the third set of contents is, but is not limited to, a sample container, optionally a label for the sample container, as well as a disinfectant (eg, iodine fore, eg, povidone iodine, iodine tincture). , Water-soluble iodine, etc.) and a skin preparation kit containing one or more swabs. The medical procedure tray 4100 of FIGS. 41A, 41B, and 41C is shown without a sample container or skin preparation kit (third section 4130 is configured for the skin preparation kit). However, FIGS. 8, 26, and 27 provide a visual reference for including one or more swabs 34 in the swab compartment 4132, with FIGS. 25-29 in the square storage compartment 4136. Provided a visual reference for including the specimen container 54, FIG. 25 is a visual reference for including a packet of disinfectant 52 in the medical procedure tray 4100 above the swab compartment 4132 and the overflow compartment 4134. I will provide a.

[0282] With reference to FIG. 41C, the medical procedure tray 4100 is the cover 4101, eg, the packaging label 62 described with reference to FIGS. 11 and 12, the identification cover 120 described with reference to FIG. 30A, or these. It is shown together with the combination of. As shown, the cover 4101 can be configured to fit above the entire medical procedure tray 4100. However, the cover 4101 can optionally be configured to fit above a portion of the medical procedure tray 4100, the portion of which is the first section 4110, the second section 4120, and the third section 4130. Contains any one or more sections selected from. The cover 4101 is alternative to fit within the medical procedure tray 4100 in any of the above configurations, eg, within the entire medical procedure tray 4100, or within a portion of the medical procedure tray 4100. Can be configured. (See, for example, covers 3801 of FIGS. 38C and 38D.) As further shown, the tray 4100 can be configured with an optional support 4102 within the first section 4110 of the tray 4100. When one or more medical procedure packages are stacked on top of a medical procedure package that includes a medical procedure tray 4100 and a cover 4101, the support 4102 is a depression of the cover 4101 and the contents of the tray 4100 underneath. It is possible to prevent damage to objects. The support shall be configured with a height substantially equal to the height of the tray 4100 and wide enough to withstand the weight of the stack of one or more medical procedure packages stacked on it. Can be done.

[0283] FIG. 42A shows a diagram of another medical procedure tray 4200 with some embodiments. 42B shows another view of the medical procedure tray 4200 of FIG. 42A.

[0284] The medical procedure tray 4200 of FIGS. 42A and 42B can have the same configuration as the medical procedure tray 4100 described with reference to FIGS. 41A and 41B. Therefore, the tray 4200 can also include a first section 4210, a second section 4220, and a third section 4230, each of which is to contain and hold the contents for a medical procedure. Can be configured in. For example, the first section 4210 is previously described, comprising a drainage system, including a catheter (eg, a Foley catheter), a drainage tube, a drainage bag, and a sterile water syringe 3892 for inflating a Foley catheter balloon. It can be configured to accommodate a first set of contents for a catheter introduction procedure. For visual reference, the sterile water syringe 3892 is shown to be mounted in or on the rack-type retainer of the first section 4210. In addition, the first section shall be configured with optional support 4202A to prevent the collapse of the cover placed on or above it, as described herein. Can be done. For example, the second section 4220 comprises a container containing a lubricant (eg, a lubricant for a Foley catheter), eg, a syringe of lubricant 4194, etc., which is the content for a previously described catheter introduction procedure. Can be configured to accommodate a second set of. For visual reference, the lubricant syringe 4194 is shown to be mounted in or on the rack-type retainer 4214 in the second section 4220. For example, a third section 4230 is a sample container, optionally a label for the sample container, as well as a disinfectant (eg, iodine fore, eg, povidone iodine, iodine tincture, water-soluble, as described herein. Swabs, which are configured to contain a third set of previously described contents for the catheter induction procedure, including a skin preparation kit containing a packet of (such as sex iodine) and one or more swabs. It can be configured with a compartment 4232, an overflow compartment 4234, and a corner storage compartment 4236.

[0285] However, with respect to the third section 4230, the third section 4230 of the tray 4200 has at least the orientation of the third section 4230 of the tray 4200 reversed with respect to any one tray of the other previously mentioned trays. It can have a different configuration than the third section of any one tray of, for example, trays 3800, 3900A-C, 4000, and 4100 in that it is oriented. For example, the orientation of the third section 3830 of the tray 3800 is such that the well 3831 of the swab compartment 3832, or the well end of the third section 3830, is adjacent to the second section 3820 of the tray 3800. .. In such an orientation, the square storage compartment 3836 shares the inner sidewall of the tray 3800 with the tray 3800. In contrast, the reverse orientation of the third section 4230 of the tray 4200 is such that the wells of the swab compartment 4232 (not shown), or the well ends of the third section 4230, form the inner sidewall of the tray 4200. It is designed to be shared with Tray 4200. In such an orientation, the square storage compartment 4236 is adjacent to the second section 4220 of the tray 4200. Any one or more of the trays provided herein, including any one or more of the trays selected from trays 3800, 3900A-C, 4000, and 4100, may be in reverse orientation. Can be configured with a third section.

[0286] With reference to FIG. 42B, the medical procedure tray 4200 is the cover 4201, eg, the packaging label 62 described with reference to FIGS. 11 and 12, the identification cover 120 described with reference to FIG. 30A, or these. It is shown together with the combination of. As shown, the cover 4201 can be configured to fit above the entire medical procedure tray 4200. However, the cover 4201 can optionally be configured to fit above a portion of the medical procedure tray 4200, the portion of which is the first section 4210, the second section 4220, and the third section 4230. Contains any one or more sections selected from. The cover 4201 is alternative to fit within the medical procedure tray 4200 in any of the above configurations, eg, within the entire medical procedure tray 4200, or within a portion of the medical procedure tray 4200. Can be configured. (See, for example, covers 3801 of FIGS. 38C and 38D.) As further shown, the tray 4200 can be configured with an optional support 4202B within the first section 4110 of the tray 4100. The support 4202B is shown in the first section 4110 at a location different from the optional support 4202A of FIG. 42A. The optional supports 4202A and 4202B can be relocated according to the need for packaging and stacking. Again, when one or more medical procedure packages are stacked on top of a medical procedure package that includes a medical procedure tray 4200 and cover 4201, a support such as support 4202B will collapse the cover 4201. , And the contents of the tray 4200 underneath it can be prevented from being damaged. Each of the supports 4202A and 4202B is sufficient to withstand a height substantially equal to the height of the tray 4200 and the weight of the stack of one or more medical procedure packages stacked on it. Can be configured with a wide range of widths.

[0287] FIG. 43 shows a diagram of another medical procedure tray 4300 according to some embodiments.

[0288] The medical procedure tray 4300 of FIG. 43 can have a configuration similar to the medical procedure tray 4200 described with reference to FIGS. 42A and 42B. Therefore, tray 4300 can also include first section 4310, second section 4320, and third section 4330 in the reverse orientation described with reference to tray 4200. Each of the first section 4310, the second section 4320, and the third section 4330 can be configured to contain and retain the contents for the medical procedure. For example, the first section 4310 is previously described comprising a drainage system comprising a catheter (eg, a Foley catheter), a drainage tube, a drainage bag, and a syringe of sterile water for inflating the balloon of the Foley catheter. It can be configured to accommodate a first set of contents for the catheter introduction procedure. Although not shown, the first section 4310 can be configured with a tab-type retainer to hold or otherwise secure the syringe of sterile water. For example, a second section 4320 is intended to contain a second set of contents for a previously described catheter introduction procedure, including a container containing a lubricant (eg, a lubricant for a Foley catheter). The lubricant container can be kept in the second section 4320 or otherwise secured by a tab-type retainer 4314 in the second section 4320. For example, a third section of reverse orientation, section 4330, is a sample container, optionally a label for the sample container, as well as a disinfectant (eg, iodine fore, eg, povidone iodine, as described herein. It is configured to contain a third set of previously described contents for the catheter introduction procedure, including a skin preparation kit containing a packet of iodine tincture, water-soluble iodine, etc.) and one or more swabs. It can be configured with a swab compartment 4332, an overflow compartment 4334, and a corner storage compartment 4336. Similar to tray 4200 in FIGS. 42A and 42B, the square storage compartment 4336 is adjacent to a second section 4320 of tray 4300. However, the second section 4320 of the tray 4300 extends entirely from the inner wall of the first section 4310 of the tray 4300 to the opposite inner wall of the tray 4300 shared by the third section 4330. On the other hand, the second section 4220 of tray 4200 does not. That being said, the second section 4220 of the tray 4200 is also entirely from the inner wall of the first section 4210 of the tray 4200 to the opposite inner wall of the tray 4200 shared by the third section 4230. Can be configured to extend to.

[0289] FIG. 44A shows a view of a removable retainer 4412 on a partition or side of a medical procedure tray according to some embodiments. FIG. 44B shows another diagram of a removable retainer 4412 on a partition or side of a medical procedure tray with hidden tabs for instructions, according to some embodiments. FIG. 44C shows another diagram of a removable retainer on a partition or side of a medical procedure tray with exposed tabs for instructions, according to some embodiments.

[0290] Any medical procedure tray provided herein is, optionally, at least a column-type or tapered column-type retainer to keep certain contents of the medical procedure package in the appropriate section. , Rack-type retainers, and any number of retainers of any type selected from tab-type retainers. For example, tray 3900A can include three tapered column type retainers that provide tray 3900B, in which three tapered column type retainers are included in the first section 3810. The sterile water syringe 3892 in the first section 3910 is kept or otherwise maintained away from the other contents of the medical procedure package containing the contents of. (See FIG. 39C and retainer 3912 in the first section 3910 that keeps the syringe 3892.) Moreover, any medical procedure tray provided herein is optional and has certain contents of the medical procedure package. It can include one or more accessory type retainers to keep things in the appropriate section. For example, as shown in FIG. 45, the accessory-type retainer 4512 is a clip section 4593 for clipping a sterile water syringe 3892 (or lubricant container 3894) to the accessory-type retainer 4512. The accessory type retainer 4512 may include a clip section 4593 attached to either the tray (eg, the side of the tray as shown) or the cover for it (eg, the back of the cover). An additional belt or strap section 4514 for this can be included. Instructions for one or more steps of the medical procedure can be printed or engraved on or in the visible surface of the belt or strap section 4514.

[0291] Whether the medical procedure tray contains one of the retainers described above (eg, column-type or tapered column-type retainers, rack-type retainers, tab-type retainers, and accessory-type retainers). Regardless, the medical procedure tray can include one or more removable retainers. An example of a removable retainer is the removable retainer 4412 of FIGS. 44A, 44B, and 44C, which separates the other contents of the medical procedure package from the sterile water syringe 3892 and the lubricant container 3894. Configured to maintain. However, it should be understood that the removable retainers are not limited to the removable retainers 4412. For example, the removable retainer can be configured to hold only a syringe of sterile water 3892 or a container of lubricant 3894 only. Moreover, the removable retainer can be configured to keep the other contents of the medical procedure package in the appropriate section for it.

[0292] As shown in FIGS. 44A, 44B, and 44C, a removable retainer, such as the removable retainer 4412, is removablely attached to the partition or side of the medical procedure tray. Clips such as clip 4414 for use can be included. The clip can be configured to clip a removable retainer onto a partition or side of the medical procedure tray, where the removable retainer is inside the medical procedure tray (eg, when packaged) or medical. It is designed to be on one of the outside of the procedure tray (eg, when in use during a medical procedure). The clip clips the removable retainer onto the partition or side of the medical procedure tray with sufficient clipping force to limit the slideable movement of the removable retainer along the side or side of the medical procedure tray. Can be configured to. Alternatively, the clip can be configured to allow such slideable movement. When the clip is configured to allow slideable movement of the removable retainer along the partition or sides of the medical procedure tray, a smaller clip force, or another capture means other than the clip force, is ejected. It can be used to capture or otherwise retain the removable retainer on a partition or side of the medical procedure tray until the possible retainer is deliberately removed.

[0293] The slideable movement of the removable retainer can be used to expose or hide instructions for one or more steps of the medical procedure. As shown in FIG. 44B, a removable retainer, such as the removable retainer 4412, is placed inside a medical procedure tray and has a foldable tab for instructions regarding one or more steps of the medical procedure. Can be hidden. The instructional foldable tabs are shown on the outside of the medical procedure tray in FIGS. 44B and 44C, but the tray can optionally be configured with the instructional foldable tabs on the inside of the tray. Regardless of the outer or inner configuration of the folding tab of the instructions, the removable retainer is slid aside as shown in FIG. 44B to expose the instructions shown in FIG. 44C. The instructions can be printed or stamped on the tabs. Again, the instructions can be hidden by pushing the tab of the instruction towards the inside or outside of the tray and by sliding the removable retainer above it. Hiding instructions in a foldable tab immediately requires the amount of information that health care providers need to know in order to carry out one or more recent steps in a medical procedure. It can be reduced to information only. And this can reduce errors in medical procedures. Moreover, the foldable tabs of the instructions can also hide the sharp edges of the tabs, if the sharp edges of the tabs are otherwise left unfolded or extended. May damage sterile packaging.

[0294] Again, the removable retainers 4412 of FIGS. 44A, 44B, and 44C are now kept away from the other contents of the medical procedure package to maintain the sterile water syringe 3892 and the lubricant container 3894. This is an example of a configured removable retainer. As shown in FIGS. 44A, 44B, and 44C, the removable retainer 4412 is for a first clip section 4493 for clipping the syringe 3892 of sterile water, and for a container of lubricant 3894. It can include another wider clip (eg, wider than clip 4414) configured with a second clip section 4495. Depending on the dimensions of the sterile water syringe 3892 and the lubricant container 3894, 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. Nevertheless, the sterile water syringe 3892 and the lubricant container 3894 can be placed in the removable retainer 4412 for one or more steps of the medical procedure. For example, instructions for one or more steps of a medical procedure may recommend connecting a sterile water syringe 3892 to a Foley catheter in the first step, and the instructions may be in the second step. In, it may be recommended to lubricate the Foley catheter.

[0295] Although the invention has been described with respect to specific modified embodiments and exemplary figures, those skilled in the art will appreciate that the invention is not limited to those modified embodiments or figures described. Let's do it. In addition, if the methods and steps described above indicate that an event occurs in an order, then the order of the steps can be changed, and such changes are modifications of the invention. Those skilled in the art will appreciate that it is based on embodiments. In addition, not only can they be performed in the order described above, but if possible, some of those processes can be performed simultaneously in parallel processes. Accordingly, to the extent that there are variants of the invention included in the spirit of the disclosure or the equivalent of the invention, which are within the scope of the claims, this patent shall also cover those variants. Is intended.
The present invention includes the following aspects.
1. 1. A tray containing a first section, a second section, and a third section.
With a tray, one or more partitions separate at least the third section from the first and second sections.
With a drainage system, including a catheter, drainage tube, and drainage bag,
It ’s a syringe of sterile water,
At least the first section comprises a sterile water syringe configured to accommodate the drainage system and the sterile water syringe.
A container containing a lubricant,
At least the second section is configured to contain the container containing the lubricant.
i) Is the bottom of the first section farther from the top of the tray than the bottom of the second section?
ii) Each section of the first and second sections includes a retainer along the opposing longitudinal sides of the tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Or,
iii) A container containing a lubricant, both i) and ii),
A skin preparation kit containing a disinfectant package and one or more swabs,
At least the third section is configured to contain the skin preparation kit.
The tray contains instructions for a catheter introduction procedure imprinted directly on the tray, with a skin preparation kit in which at least a portion of the instructions is exposed in accordance with the steps of the catheter introduction procedure.
A catheter introduction package.
2. 2. 1. The bottom of the first section is farther from the top of the tray than the bottom of the second section. The catheter introduction package described in.
3. 3. The second section-separated partition of the one or more partitions further separates the second section from the first section.
The second section-separated partition has a maximum height substantially equal to the height of the tray. Or 2. The catheter introduction package described in.
4. Each section of the first and second sections has the retainer along the opposite longitudinal sides of the tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Including 1. The catheter introduction package described in.
5. The second section-separated partition of the one or more partitions further separates the second section from the first section.
The second section-separated partition has a maximum height that is substantially smaller than the height of the tray.
The bottom of the first section is coplanar with the bottom of the second section.
1. 1. Or 4. The catheter introduction package described in.
6. The third section is
A swab compartment comprising wells and one or more grooves, wherein the one or more grooves are configured to hold the one or more swabs therein by snap fitting tabs, respectively. Swab compartment and
An overflow compartment that is fluidly connected to the well through the one or more grooves, wherein the one or more grooves are further configured to carry the disinfectant poured therein to the well. Overflow compartments and
With a square storage compartment configured to house the sample container
Including 1. ~ 5. The catheter introduction package described in any of.
7. The one or more grooves are angled with respect to the bottom of the tray and the handle ends of the respective swabs of the one or more swabs when held under the snap fit tab. 6. The section is adapted to be lifted relative to the absorbent head end when the absorbent head end is in the well. Medical procedure package described in.
8. A third section partition of the one or more partitions at the well end of the swab compartment separates the well directly from the second section. ~ 7. The catheter introduction package described in any of.
9. The well end of the swab compartment shares the inner wall of one of the longitudinal sides of the tray with the tray. ~ 7. The catheter introduction package described in any of.
10. A support is further provided within the first section, which is substantially equal to the height of the tray and the weight of one or more catheter introduction packages stacked on it. It has a width sufficient to withstand 1. ~ 9. The catheter introduction package described in.
11. With a sterile wrap configured to fold around the tray,
A pericare kit packaged with the tray on the outside of the sterile wrap,
An outer band of the sterile wrap for holding the sterile wrap in the folded configuration around the tray, the band being in what orientation the tray is placed before opening the sterile wrap. With an obi, including instructions on whether to put it,
A packaging label on the outside of the sterile wrap that identifies the catheter introduction package, wherein the packaging label contains information that highlights the basic characteristics of the catheter introduction package in a quick and easy-to-read manner. With label
1. ~ 10. The catheter introduction package described in any of.
12. A tray containing a first section, a second section, and a third section.
With a tray, one or more partitions separate at least the third section from the first and second sections.
With a drainage system, including a Foley catheter, drainage tube, 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 accommodate the drainage system and the syringe of sterile water.
A container containing a lubricant for the Foley catheter.
At least the second section is configured to contain the container containing the lubricant.
i) Is the bottom of the first section farther from the top of the tray than the bottom of the second section?
ii) Each section of the first and second sections includes a retainer along the opposing longitudinal sides of the tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Or,
iii) A container containing a lubricant, both i) and ii),
A skin preparation kit containing a disinfectant package and one or more swabs,
The third section is
A swab compartment comprising wells and one or more grooves, wherein the one or more grooves are configured to hold the one or more swabs therein by snap fitting tabs, respectively. Swab compartment,
An overflow compartment that is fluidly connected to the well through the one or more grooves, wherein the one or more grooves are further configured to carry the disinfectant poured therein to the well. Overflow compartments, as well as
A corner storage compartment, wherein the third section is configured to house the package of the disinfectant above the swab compartment, the overflow compartment, the corner storage compartment, or a combination thereof. , Corner storage compartment
Including
The tray contains instructions for a catheter introduction procedure imprinted directly on the tray, with a skin preparation kit in which at least a portion of the instructions is exposed in accordance with the steps of the catheter introduction procedure.
A catheter introduction package.
13. The bottom of the first section is farther from the top of the tray than the bottom of the second section.
The second section-separated partition of the one or more partitions further separates the second section from the first section.
The second section-separated partition has a maximum height substantially equal to the height of the tray. The catheter introduction package described in.
14. Each section of the first and second sections has the retainer along the opposite longitudinal sides of the tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Including,
The bottom of the first section is coplanar with the bottom of the second section.
12. The catheter introduction package described in.
15. The second section-separated partition of the one or more partitions further separates the second section from the first section.
The second section-separated partition has a maximum height that is substantially smaller than the height of the tray.
1. 1. Or 14. The catheter introduction package described in.
16.
A tray containing a first section, a second section, and a third section, wherein one or more partitions separate at least the third section from the first and second sections. When,
A first set of contents for a medical procedure, at least said first section with a first set of contents configured to accommodate the first set of contents. ,
A second set of contents for the medical procedure,
At least the second section is configured to accommodate a second set of the contents.
i) Is the bottom of the first section farther from the top of the tray than the bottom of the second section?
ii) Each section of the first and second sections holds at least a portion of the first set and the second set of the contents for the medical procedure, respectively. Includes retainers along opposite longitudinal sides of the
iii) A second set of contents, both i) and ii),
A third set of contents for the medical procedure.
At least the third section is configured to accommodate a third set of the contents.
A swab compartment comprising wells and one or more grooves, wherein the one or more grooves are configured to hold one or more swabs therein by snap fitting tabs, respectively. section,
An overflow compartment fluidly connected to the well through the one or more grooves, wherein the one or more grooves are further configured to carry the fluid poured into the well to the well. Overflow compartment, as well as,
Weapon storage compartment
Including
The tray contains instructions for the medical procedure imprinted directly on the tray, of which at least a portion of the instructions is exposed in accordance with the steps of the medical procedure, a third of the contents. With a set of
A medical procedure package.
17. 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 substantially equal to the height of the tray.
16. Medical procedure package described in.
18. Each section of the first and second sections said on the tray to hold at least a portion of the first set and the second set of contents for the medical procedure, respectively. Along the opposing longitudinal sides, the retainer is included.
The bottom of the first section is coplanar with the bottom of the second section.
16. Medical procedure package described in.
19. 16. The one or more partitions have a maximum height that is substantially less than the height of the tray. Or 18. Medical procedure package described in.
20. The medical procedure is a catheter introduction procedure.
A first set of the contents for the catheter introduction procedure includes a drainage system, the drainage system including a Foley catheter, a drainage tube, a drainage bag, and a syringe of sterile water for inflating the balloon of the Foley catheter. Including
A second set of the contents for the catheter introduction procedure comprises a container containing a lubricant for the Foley catheter.
A third set of the contents for the catheter introduction procedure includes a skin preparation kit, the skin preparation kit comprising a disinfectant package and one or more swabs.
The third section is configured to house the package of the disinfectant above the swab compartment, the overflow compartment, the square storage compartment, or a combination thereof.
16. ~ 19. The medical procedure package described in any of.

Claims (24)

The first section, defined by the outer wall and the inner partition,
A first section that is separated from the first section by a first portion of the inner partition, wherein the first section is equal to the height of the outer wall defining the first section. With a second section, which has a height of
A third section that is separated from the first section by a second portion of the inner partition, wherein the inner partition along the second portion has the first height and the first height. A catheter introduction tray comprising a third section having a second height less than or equal to, the third section having an inclined surface and a third section having a well located at the lower end of the inclined surface.
With a drainage system, including a catheter, drainage tube, and drainage bag,
It ’s a syringe of sterile water,
At least the first section comprises a sterile water syringe configured to accommodate the drainage system and the sterile water syringe.
A container containing a lubricant,
At least the second section is configured to contain the container containing the lubricant.
i) Is the bottom of the first section farther from the top of the catheter introduction tray than the bottom of the second section?
ii) Each section of the first and second sections retainers along opposite longitudinal sides of the catheter introduction tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Or
iii) Both i) and ii),
A container containing a lubricant and
A skin preparation kit that includes a disinfectant package and multiple swabs,
At least the third section is configured to contain the skin preparation kit.
The plurality of swabs are arranged on the inclined surface of the third section, each comprising an absorbent head and an elongated member, and the absorbent head of each of the plurality of swabs is positioned in the well. , The elongated member of each of the plurality of swabs extends through the inclined surface on the opposite side of the well.
A partition at the end of the well separates the well directly from the second section.
The catheter introduction tray contains instructions for the catheter introduction procedure imprinted directly on the catheter introduction tray, at least a portion of the instructions being exposed in time with the steps of the catheter introduction procedure. Skin preparation kit and
A sterile wrap that folds around the catheter introduction tray,
A catheter introduction package. The catheter introduction package according to claim 1, wherein the bottom of the first section is farther from the top of the catheter introduction tray than the bottom of the second section. Each section of the first and second sections said, along the opposite longitudinal sides of the catheter introduction tray, to hold the syringe of sterile water and the container containing the lubricant, respectively. The catheter introduction package of claim 1, comprising a retainer. The bottom of the first section is coplanar with the bottom of the second section.
The catheter introduction package according to claim 1 or 3. The third section is
A swab compartment comprising said wells and a plurality of grooves, wherein the plurality of grooves are configured to hold the plurality of swabs therein by snap fitting tabs, respectively.
An overflow compartment that is fluidly connected to the well through the plurality of grooves, wherein the plurality of grooves are further configured to transport the disinfectant poured therein to the well. When,
The catheter introduction package according to any one of claims 1 to 4, comprising a square storage compartment configured to contain a sample container. The plurality of grooves are provided on the inclined surface angled with respect to the bottom of the catheter introduction tray, and each swab of the plurality of swabs when held under the snap fitting tab. 5. The catheter introduction package of claim 5, wherein the handle end of the catheter is adapted to be lifted relative to the absorbent head end when the absorbent head end is in the well. A support is further provided in the first section, the support being substantially equal to the height of the catheter introduction tray, and one or more catheter introduction packages stacked on it. The catheter introduction package according to any one of claims 1 to 6, which has a width sufficient to withstand the weight of the catheter. A pericare kit packaged with the catheter introduction tray on the outside of the sterile wrap,
An outer band of the sterile wrap for holding the sterile wrap folded around the catheter introduction tray, the band being oriented in any orientation of the catheter introduction tray prior to opening the sterile wrap. With an obi, including instructions on whether to put it in,
A packaging label on the outside of the sterile wrap that identifies the catheter introduction package, wherein the packaging label contains information that highlights the basic features of the catheter introduction package in a quick and easy-to-read manner. The catheter introduction package according to any one of claims 1 to 7, further comprising a label. The catheter introduction package according to claim 1, wherein the second section and the third section extend along the outer peripheral wall by a distance equal to the length direction of the catheter introduction tray. The catheter-introducing package of claim 1, wherein the sterile water syringe is positioned along the outer wall in the first section. The catheter-introducing package of claim 10, wherein the sterile water syringe is secured by a retainer along the outer wall. 11. The catheter-introducing package of claim 11, wherein the retainer comprises a strap that is coupled to the outer wall. 11. The catheter-introducing package of claim 11, wherein the retainer comprises a plurality of columns extending from the bottom of the first section, wherein the plurality of columns are spaced at equal distances from the outer wall. The retainer comprises a plurality of columns extending from the bottom of the first section, one of the plurality of columns being offset from a line passing through at least two of the plurality of columns. The catheter introduction package according to claim 11, which extends parallel to the outer peripheral wall along the first length. The retainer comprises a plurality of racks extending from the bottom of the first section, the plurality of racks having a height smaller than the height of the outer peripheral wall, and the sterile water syringe having the plurality of racks. The catheter introduction package according to claim 11, which is mounted on a rack. 11. The catheter-introducing package of claim 11, wherein the retainer comprises a removable clip, wherein the clip has a first clip section configured to hold the syringe of sterile water. The catheter-introducing package of claim 10, wherein the sterile water syringe is held between the outer peripheral wall and the inner partition. The catheter introduction package of claim 10, further comprising a cover covering the drainage system in the first section. The catheter-introducing package of claim 18, wherein the cover comprises a retainer configured to accommodate the sterile water syringe. The catheter introduction package according to claim 1, wherein the first portion of the inner partition is in contact with the outer peripheral wall. A catheter introduction tray comprising a first section, a second section, and a third section.
With a catheter introduction tray, one or more partitions separate at least the third section from the first and second sections and the first section from the second and third sections.
With a drainage system, including a Foley catheter, drainage tube, 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 accommodate the drainage system and the syringe of sterile water.
A container containing a lubricant for the Foley catheter.
At least the second section is configured to contain the container containing the lubricant.
i) Is the bottom of the first section farther from the top of the catheter introduction tray than the bottom of the second section?
ii) Each section of the first and second sections retainers along opposite longitudinal sides of the catheter introduction tray to hold the syringe of sterile water and the container containing the lubricant, respectively. Or
iii) A container containing a lubricant, both i) and ii),
A skin preparation kit containing a disinfectant package and one or more swabs,
The third section has an inclined surface and
A swab compartment comprising wells and one or more grooves, wherein the one or more grooves are configured to hold the one or more swabs therein by snap fitting tabs, respectively. Swab compartment,
An overflow compartment that is fluidly connected to the well through the one or more grooves, wherein the one or more grooves are further configured to carry the disinfectant poured therein to the well. Overflow compartments, as well as
A corner storage compartment, wherein the third section is configured to house the package of the disinfectant above the swab compartment, the overflow compartment, the corner storage compartment, or a combination thereof. , Including horn storage compartment,
The catheter introduction tray contains instructions for the catheter introduction procedure imprinted directly on the tray, at least a portion of the instructions being exposed for the steps of the catheter introduction procedure, skin preparation. Catheter introduction package with kit. The bottom of the first section is farther from the top of the catheter introduction tray than the bottom of the second section.
21. The partition of the one or more partitions that separates the second section from the first section has a maximum height substantially equal to the height of the catheter introduction tray. The described catheter introduction package. Each section of the first and second sections said, along the opposite longitudinal sides of the catheter introduction tray, to hold the syringe of sterile water and the container containing the lubricant, respectively. Including retainer
The bottom of the first section is coplanar with the bottom of the second section.
The catheter introduction package according to claim 21 . Of the one or more partitions, the partition that separates the second section from the first section has a maximum height that is substantially smaller than the height of the catheter introduction tray.
The catheter introduction package according to claim 1 or 23 .

Images