Folded sterile diaper assembly

Abstract

This document discloses a sterile drape assembly comprising a surgical drape configured to be placed over a patient's pelvic region during a urinary catheterization procedure. The drape includes a window configured to be placed over the patient's genital region. A base pad is configured to be placed below the patient's pelvic region and is attached to the drape and a central supply compartment (CSR) wrapping to define the assembly. The assembly is capable of transitioning from an initial folded state to an unfolded state. In the folded state, a tray containing medical devices and / or supplies is enclosed by the assembly. Adhesive patches on the drape attach the drape to the patient. The assembly is also capable of transitioning from the unfolded state to a final folded state after the procedure.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 545,713, filed October 25, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] In the patient care setting, medical errors (including human error) remain a leading cause of poor patient outcomes or other complications associated with medical procedures. Inattention or distraction during medical procedures can often lead to a breach of the sterile environment, potentially resulting in hospital-acquired infections. The number of tasks and / or medical components associated with a medical procedure can be linked to the incidence of hospital-acquired infections or other complications related to breaches of the sterile barrier. Currently, workflows for establishing a sterile work area for sterile urinary catheter insertion techniques (e.g., Foley® catheters) involve multiple steps and components, such as CSR wraps and base pads, and fenestrated covers, which need to be positioned and placed without contaminating the sterile work area. Such multiple steps and components represent a heavy neurological burden on nurses in an already busy environment, potentially leading to omissions in aseptic technique.

[0004] This article discloses systems, devices, and methods for reducing the number of steps and components associated with aseptic techniques during the placement of medical devices, including Foley® catheters, into a patient. Summary of the Invention

[0005] In brief, the embodiments disclosed herein relate to a sterile drape assembly for use during medical procedures, particularly during urinary catheter insertion. The sterile drape assembly comprises a combination of components for establishing a sterile environment for catheter insertion procedures, which, in the absence of the sterile drape assembly, can be used individually to establish a sterile environment.

[0006] This document discloses a sterile drape assembly, which, according to some embodiments, includes: (i) a sterile drape having a window, wherein the drape is configured to be placed over the pelvic region of a patient during a urinary catheterization procedure; (ii) a central supply chamber (CSR) wrapping; and (iii) a base pad coupled between the drape and the wrapping. The sterile drape assembly is convertible between a first folded configuration and an unfolded configuration.

[0007] In some embodiments, the opening is configured to allow access to the patient’s genitals when the drape is placed over the pelvic region, and in some embodiments, the drape includes multiple adhesive patches configured to secure the drape to the patient during a urinary catheter placement procedure.

[0008] In some embodiments, the base pad includes a sealing layer disposed across the underside of the base pad and a fluid-absorbing layer disposed on top of the sealing layer. In some embodiments, the base pad is configured to be placed under the patient's pelvic region during a urinary catheterization procedure, and the fluid-absorbing layer is configured to collect fluid associated with the urinary catheterization procedure.

[0009] In some embodiments, the cover is attached to the base pad along its proximal peripheral edge, and the base pad is attached to the wrapper along its proximal peripheral edge. In some embodiments, the cover is attached to the base pad such that, in the unfolded configuration, the cover extends distally away from the base pad. In some embodiments, the cover is attached to the base pad on its top surface such that, in the unfolded configuration, the proximal segments of the cover overlap with the base pad. In some embodiments, the wrapper is attached to the base pad such that, in the unfolded configuration, the wrapper extends proximally away from the base pad. In some embodiments, the base pad is attached to the wrapper on its top surface such that, in the unfolded configuration, the proximal segments of the base pad overlap with the distal segments of the wrapper. In some embodiments, the distal segments of the wrapper include triangular corner segments of the wrapper.

[0010] In some embodiments, in the first fold configuration, the cover and the base pad are enclosed by a wrapping material. In some embodiments, in the first fold configuration, the cover is enclosed by the base pad.

[0011] In some implementations, the component also includes a tray that holds multiple instruments, devices, or supplies to be used during the urinary catheter placement procedure, wherein in a first folding configuration, the tray is enclosed by a wrapping.

[0012] In some embodiments, the component further includes a strap configured to secure the component in a first folded configuration. In some embodiments, the strap includes markings indicating the orientation of the component when it is converted to an unfolded configuration.

[0013] In some embodiments, the component is configured to transition from an unfolded configuration to a second folded configuration, such that the cover and base pad are enclosed by a wrapping material. In some embodiments, in the second folded configuration, the absorbent layer is enclosed by a sealing layer.

[0014] This article also discloses a method of using a sterile drape assembly, according to some embodiments, the method including providing a drape assembly in a first folded configuration to prepare for performing a urinary catheter placement procedure on a patient. The method further includes: unfolding the covering of the drape assembly to expose the base pad of the drape assembly; and unfolding the base pad of the drape assembly, wherein the base pad is attached to the covering. The method further includes: (i) placing the base pad under the patient; (ii) unfolding the drape of the drape assembly, wherein the drape is attached to the base pad; and (iii) placing the drape over the patient's pelvic region such that the opening of the drape is positioned over the patient's genital region.

[0015] In some embodiments of the method, unfolding the package includes a tray exposed within a cover assembly in a first folded configuration, wherein the tray contains at least one of a medical device, medical equipment, or supplies to be used during the catheter placement procedure.

[0016] In some embodiments of the method, unfolding the drape includes: (i) unfolding a first wing of the drape along a first fold line extending along the right side of the drape assembly; (ii) after unfolding the first wing, unfolding a second wing of the drape along a second fold line extending proximally along the drape assembly; (iii) after unfolding the second wing, unfolding a third wing of the drape along a third fold line extending distally along the drape assembly, wherein a base pad is attached to the third wing; and after unfolding the third wing, unfolding a fourth wing of the drape along a fourth fold line extending along the left side of the drape assembly. In some embodiments, the method further includes attaching the drape to the patient via a plurality of adhesive patches on the drape.

[0017] In some embodiments, the method further includes folding a cover over the top of the base pad after performing the catheter placement procedure. In some embodiments, the method further includes folding the base pad such that (i) the cover is enclosed by the base pad, and (ii) the liquid-absorbing layer of the base pad is enclosed by the bottom sealing layer of the base pad.

[0018] In some embodiments, the method further includes folding the wrapping to define a second folded configuration of the cover assembly. In some embodiments of the method, folding the wrapping includes enclosing a base pad within the wrapping. In some embodiments of the method, folding the wrapping includes enclosing a tray containing medical devices or surgical supplies within the wrapping.

[0019] In some embodiments of the method, folding the package to define a second fold configuration includes: (i) folding a fourth wing inward along a fourth fold line; (ii) folding a third wing inward along a third fold line after folding the fourth wing; and (iii) folding a second wing inward along a second fold line after folding the third wing; and (iv) folding a first wing inward along a first fold line after folding the second wing.

[0020] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which disclose specific embodiments of such concepts in more detail. Attached Figure Description

[0021] Figure 1A A sterile drape assembly in an unfolded configuration is shown according to some embodiments disclosed herein.

[0022] Figure 1B The first fold configuration is shown according to some embodiments disclosed herein. Figure 1A Components.

[0023] Figure 2A The following are examples of patient-specific embodiments according to the disclosure herein. Figure 1A A floor plan of the components.

[0024] Figure 2B The following are examples of patient-specific embodiments according to the disclosure herein. Figure 1A The side view of the component.

[0025] Figure 3 Some embodiments disclosed herein are shown. Figure 1A A detailed cross-sectional view of a portion of the base pad of the component.

[0026] Figures 4A to 4F The following are some embodiments disclosed herein: Figure 1B The first fold configuration is converted to Figure 1A The various stages of the unfolded configuration Figures 1A to 1B Components.

[0027] Figure 5A This illustrates a component in its first folded state during a transition toward a second folded configuration, according to some embodiments disclosed herein. Figures 1A to 1B The side view of the component.

[0028] Figure 5B This illustrates a component in a second-folded state during the transition to a second-folded configuration, according to some embodiments disclosed herein. Figure 5A A close-up view of the combination of the base pad and cover cloth of the components.

[0029] Figure 6 The placement of a base pad under the patient is shown in some embodiments disclosed herein. Figure 1A The side view of the component.

[0030] Figure 7 This is based on the use of some implementation schemes disclosed in this article. Figures 1A to 1B A flowchart of the methods of the component.

[0031] Figure 8 Another embodiment of a sterile drape assembly in an unfolded configuration according to some embodiments disclosed herein is shown. Detailed Implementation

[0032] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may optionally be combined with or replace features of any of the many other embodiments disclosed herein.

[0033] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise.

[0034] The terms "proximal" and "distal" refer to opposite ends or opposite portions of a medical device, including the devices or components disclosed herein. As used herein, the proximal portion of a medical device is the portion closest to the clinician during use, while the distal portion is the portion located at the opposite end. For example, the proximal portion of a base pad is defined as the portion closest to the clinician during use of a sterile drape assembly. The distal portion is the portion opposite the proximal portion, such as the portion placed below the patient's pelvis.

[0035] Throughout this specification, approximate values ​​may be referenced, such as by using the term "substantially". For each such reference, it should be understood that in some embodiments, values, features, or characteristics may be specified without approximation. For example, when using qualifying terms such as "about" or "substantially", these terms include, within their scope, the cases where the qualifying word has no qualifying word. Unless otherwise stated, all measurements, values, ratings, locations, quantities, dimensions, and other specifications set forth in this specification (including those set forth in the appended claims) are approximate and not precise. They are intended to have a reasonable range consistent with the function they relate to and with the conventions of the art to which they belong.

[0036] The phrase “connected to” or “linked with” refers to any form of interaction between two or more entities, including but not limited to mechanical and fluid interactions. Two components can be linked to each other even if they are not in direct contact. For example, two components can be linked to each other through an intermediate component. The phrase “attached to” refers to a direct physical connection between two components.

[0037] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions are interchangeable with each other. In other words, the order and / or use of a particular step and / or action may be modified unless proper operation of the embodiment requires a particular order of steps or actions. Furthermore, a subroutine or only a portion of the method described herein may be a separate method within the scope of the disclosed text. In other words, some methods may include only a portion of the steps described in the more detailed methods. Additionally, all embodiments disclosed herein are composable and / or interchangeable unless otherwise stated, or such combination or interchange would be contrary to the operability of any embodiment.

[0038] Figure 1A This is a plan view of the sterile drape assembly (assembly) 100. Component 100 is typically configured for use by clinicians during a procedure (procedure) for placing a patient's urinary catheter (e.g., a Foley® catheter). Component 100 is configured in a folded configuration (see [reference]). Figure 1B )and Figure 1A The conversion between the unfolded configurations is shown. In one embodiment, component 100 may be initially arranged in a first folded configuration and then converted to an unfolded configuration during use, such as during administration to a patient.

[0039] In one embodiment, component 100 may be assembled at its manufacturing location and initially arranged in (i.e., folded into) a first folded configuration, and provided to a healthcare facility in the first folded configuration. In some embodiments, component 100 may be sterilized in the first folded configuration. In an alternative embodiment, the individual components of component 100 may be provided to a healthcare facility. According to the embodiments, component 100 may be assembled at the healthcare facility and initially arranged in the first folded configuration.

[0040] Component 100 can be configured in a single size for patients of all sizes. Alternatively, component 100 can be provided with one or more parts selected from a plurality of different sizes, wherein the different sizes are configured for patients of different sizes and / or shapes. Component 100 can be gender-neutral, i.e., configured for female or male patients. In other embodiments, component 100 may include a female form different from the male form.

[0041] Component 100 typically comprises at least three parts packaged together. These three parts include a base pad 110, a central supply compartment CSR wrap (CSR wrap) 130, and a cover 120. As described above, in one embodiment, the base pad 110, CSR wrap 130, and cover 120 may be separate components. In other words, either the CSR wrap 130 or the cover 120 may be configured to function as a separate, independent device from other components. In another embodiment, two or more of the base pad 110, CSR wrap 130, and cover 120 may be securely attached together. Each of the base pad 110, CSR wrap 130, and cover 120 defines a top and bottom side, respectively designated as 110A, 110B, 120A, 120B, 130A, and 130B. Component 100 may also include (though not required) various surgical items 140 to be used during the procedure, such as sterile swabs, catheter components, tools, instruments, syringes, medical solutions, etc., and the surgical items 140 may be housed in a tray 142.

[0042] Figure 1A One embodiment is shown in which the base pad 110, CSR wrap 130, and cover 120 are permanently attached together, such that the base pad 110, CSR wrap 130, and cover 120 remain attached together throughout the entire use of the assembly 100. In other embodiments, the base pad 110, CSR wrap 130, and cover 120 are separately attached, such that any two of these components can be separated from each other, and in some embodiments, they can be reattached together, such as by reattaching them in different relative positions or orientations.

[0043] In the illustrated embodiment, the base pad 110 is attached to the cover 120 via a first attachment patch 112 (e.g., an adhesive patch) disposed on the top side 110A of the base pad 110. The first attachment patch 112 is located at the proximal end 129 of the cover 120 and spaced apart from the distal end of the base pad 110, such that the proximal segment 129A of the cover 120 overlaps with the distal segment 115 of the base pad 110. Attaching the proximal end 129 of the cover 120 to a location spaced apart from the distal end of the base pad 110 is advantageous in several aspects, as described below. However, in other embodiments, the first attachment patch 112 may be located at the distal end of the base pad 110, such that the base pad 110 and the cover 120 do not overlap in the unfolded configuration.

[0044] The base pad 110 is typically configured to be placed under the patient's pelvic region during a procedure (i.e., between the patient and the examination table or bed surface). A key functionality of the base pad 110 is to capture and contain any fluids associated with the procedure, such as cleaning fluids, disinfectant fluids, or bodily fluids. The base pad 110 may include a rectangular shape, but other shapes such as square, circular, elliptical, or trapezoidal are also contemplated. The base pad 110 may also include a peripheral seal that extends along the entire periphery of the base pad 110. The peripheral seal is configured to prevent leakage or seepage of fluid from the base pad 110 along its peripheral edges (including the entire peripheral edge). Figure 3 Further details regarding the construction of the base gasket 110, including the peripheral seal, are shown and described accordingly.

[0045] A drape 120 (commonly referred to as a surgical drape in the medical industry) is configured to cover a patient's pelvic region during procedures. The drape 120 may be formed of a material resistant to fluid and microbial penetration, such as polypropylene or polyester. The drape 120 includes an opening 122 extending between a top side 120A and a bottom side 120B. The location, shape, and size of the opening 122 are designed to allow the clinician access to the patient's genitals during the procedure. The drape 120 may optionally include a notch 124 extending inwardly from the distal end of the drape 124; the notch may be V-shaped. The notch 124 can facilitate the placement of the drape 120 over the pelvic region. In the illustrated embodiment, the drape 120 includes a rectangular shape. However, the drape 120 is not limited to a rectangular shape. Other shapes, such as elliptical, circular, square, hourglass-shaped, trapezoidal, etc., are contemplated.

[0046] The drape 120 is configured to be attached to the patient during the procedure. Therefore, the drape 120 may include a plurality of adhesive patches disposed on the underside 120B of the drape 120. Each adhesive patch may include an adhesive that facilitates attachment to the patient's skin, such as a pressure adhesive achieved by removing the backing layer. The drape 120 includes a plurality (e.g., one, two, three, or more) of pelvic adhesive patches 126 located on the drape 120 to facilitate attachment of the drape 120 to the patient's pelvic region, such as near the distal end of the drape 120. The drape 120 may also optionally include a plurality (e.g., one, two, three, or more) of leg adhesive patches 128 located on the drape 120 to facilitate attachment of the drape 120 to the patient's legs, such as near the right and left sides of the drape 120.

[0047] CSR wrap 130 is a fabric panel typically configured to hold a medical device or other article thereon during a procedure. CSR wrap 130 can be sterilized via a variety of different sterilization techniques, such as exposure to vapor or ethylene oxide gas. The material of CSR wrap 130 may include polypropylene or other relatively robust synthetic materials to resist tearing or puncture during use. In some embodiments, the material may include a cellulose material configured to prevent skin irritation. Other material characteristics may include breathability and low shedding. The material of CSR wrap 130 may include woven or non-woven fabrics. In the illustrated embodiment, CSR wrap 130 includes a square shape. However, CSR wrap 130 is not limited to a square shape. Other shapes, such as rectangular, trapezoidal, etc., are contemplated.

[0048] In the illustrated embodiment, the base pad 110 is attached to the CSR package 130 via a second attachment patch 113 (e.g., an adhesive patch) disposed between the bottom side 110B of the base pad 110 and the top side 130A of the CSR package 130. The second attachment patch 113 is located at the proximal end of the base pad 110 and spaced apart from the distal end 134 (i.e., the corner end) of the CSR package 130, such that the proximal portion of the base pad 110 overlaps with the distal segment 135 of the triangle of the CSR package 130. Attaching the proximal end of the base pad 110 to a position spaced apart from the distal end of the CSR package 130 is advantageous in several respects, as described below.

[0049] Figure 1BComponent 100 in a first fold configuration is shown. Component 100 can be configured for storage in the first fold configuration. In some embodiments, component 100 may be encapsulated in the first fold configuration within an outer package (bag or pouch, not shown), wherein the outer package provides a sterile barrier for component 100 until component 100 is removed from the outer package. The first fold configuration may be defined such that the bottom side 130B of the CSR package 130 defines the entire outer surface of component 100 in the first fold configuration, or in other words, the top side 130A of the package 130 is substantially encapsulated by the bottom side 130B of the package 130.

[0050] Component 100 may include a strap 105 configured to secure component 100 in a first folded configuration. The strap 105 may extend around the entire circumference of component 100 in the first folded configuration. The strap 105 may be formed of a fragile material (e.g., paper) to allow clinicians to convert component 100 from the first folded configuration to an unfolded configuration. As an example, the strap 105 may include a first end 105A overlapping a second end 105B, wherein an adhesive patch 105C secures the first end 105A to the second end 105B. The adhesive of the adhesive patch 105C may be configured such that the first end 105A can be reattached to the second end 105B at a later time (e.g., after a procedure). Although not shown, in the first folded configuration, the strap 105 can be attached along the bottom side of the component 100 to the bottom side 130B of the CSR wrap 130, and can remain attached to the bottom side 130B of the CSR wrap 130 when the component 100 is converted to the unfolded configuration and during the procedure.

[0051] The band 105 may include one or more markings or text. The band 105 may include markings 106 (e.g., arrows) indicating the orientation of component 100. For example, marking 106 may indicate the intended use orientation of component 100 such that once component 100 is converted to its unfolded configuration, component 100 is correctly oriented relative to the patient. Such markings 106 can prevent clinicians from needing to reorient component 100 after it has been converted or partially converted from its first folded configuration to its unfolded configuration. The band 105 may also include textual information 107, such as instructions for use.

[0052] Component 100 can be configured to transform (i.e., fold into) a second folded configuration (not shown) after use, wherein the second folded configuration may be similar in some respects to the first folded configuration. The second folded configuration can be configured to retain any collected fluid using a sealing layer of the base pad 110, as further described below. Therefore, clinicians can dispose of the waste component 100 without concern about any collected fluid leaking from the component 100 in the second folded configuration. The second folded configuration can be further configured to accommodate and retain any disposable items used in the catheter placement procedure, such as gloves, disposable tools, catheter components, or packaging, including, for example, tray 142 and surgical items 140. Thus, the component 100 in the second folded configuration can constitute a safe and efficient mechanism or method for transporting any or all disposable items used in the procedure (which may be biohazardous) from the point of use to a point of disposal of waste medical supplies.

[0053] Figure 2A , Figure 2B Component 100 for use with a patient is shown. Figure 2A A top view of a patient 250 (male or female) is shown, including a pelvic region 252 and a genital region 254. Component 100 is shown for use with the patient 250, wherein a base pad 110 is placed under the pelvic region 252, and a CSR wrap 130 is placed in front of the patient 250, such as between the patient 250's legs. A tray 142 containing surgical items 140 is placed on the top side 130A of the CSR wrap 130. A drape 120 is applied to the pelvic region 252 such that an opening 122 is applied over the genital region 254. A pelvic adhesive patch 126 is attached to the pelvic region 252, and a leg adhesive patch 128 is attached to the patient 250's legs (e.g., inner thighs).

[0054] Figure 2B A side view of patient 250 during the use of component 100 is shown. For clarity, part of patient 250's right leg and right arm have been removed. A base pad 110 is shown positioned below pelvic region 252, and a CSR wrap 130 is shown positioned in front of patient 250, the CSR wrap having a tray 140 placed on top of the CSR wrap 130, the tray containing surgical items 140. A drape 120 is shown covering pelvic region 252, with a window 122 positioned above genital region 254. A pelvic adhesive patch 126 is shown securing the drape 120 to the skin surface of pelvic region 252, and a leg adhesive patch 128 is shown securing the drape 120 to the skin surface of patient 250's left leg. In some cases, a proximal portion 129A (including the proximal end 129 of the drape 120) may be positioned below pelvic region 252.

[0055] Figure 3 It is along Figure 1A The diagram shows a cross-sectional view of a portion of the base pad 110 taken by section line 3-3. The base pad 110 may include multiple (e.g., one, two, three, or more) layers, with different layers defining different functionalities of the base pad 110. As an example, the base pad 110 may include a top layer 311, an intermediate absorbent layer 312, and a bottom sealing layer 313. The top layer 311 is typically configured to make skin contact with the patient 250. Therefore, the top layer 311 can provide padding to help comfort the patient during procedures. The top layer 311 may also allow fluid to pass through the top layer 311 to the intermediate absorbent layer 312 (as indicated by arrow 303). In some embodiments, the top layer 311 may include a spunbond polypropylene material. The intermediate absorbent layer 312 is typically configured to receive and absorb fluid 303 from the top layer 311. Therefore, the combination of the intermediate absorbent layer 312 and the top layer 311 can help minimize contact between the fluid 303 and the patient 250. In some embodiments, the intermediate absorbent layer 312 may be formed of a cellulose material configured to absorb liquid 303. The bottom sealing layer 313 is configured to provide a liquid seal along the bottom side 110B of the base pad 110, such that the liquid 303 absorbed by the intermediate layer 312 remains contained within the base pad 110. The bottom sealing layer 313 may be formed of any suitable sealing material typically used for such purposes, such as a plastic film. As described above, the base pad 110 may include a peripheral seal 308. As an example, the peripheral seal 308 may be formed by extending the bottom sealing layer 313 upward around and inward from the peripheral edge 305 along the top side 110A of the base pad 110.

[0056] Figures 4A to 4F Component 100 is illustrated in various states transitioning between a first folded configuration and an unfolded configuration. The various states are shown in the unfolded sequence, and these states, when reversed, can illustrate component 100 in the sequence transitioning from the unfolded configuration to the first folded configuration. It should be noted that the folding / unfolding states shown represent one exemplary process of folding / unfolding the component. Other folding / unfolding states, processes, or methods are contemplated, as will be understood by those skilled in the art.

[0057] Figure 4AThe assembly 100 is shown in a first unfolded state, with the strap 105 separated to allow further unfolding of the assembly 100. The strap 105 is attached to the bottom side of the assembly 100, i.e., in the first folded configuration, a portion of the bottom side 130B of the CSR wrapper 130 is arranged across the bottom side of the assembly 100. For illustrative purposes, the assembly 100 defines a distal side 401, a right side 402, a proximal side 403, and a left side 404. Note that in the first folded configuration, the bottom side 130B of the CSR wrapper 130 defines substantially the entire outer surface of the assembly 100. Figure 4A As shown, the first flap 410 extends across the top side of the assembly 100 (i.e., the side facing away from the page). In some embodiments, the first flap 410 may include a corner tab 410 folded back over the first flap 410. The corner tab 410A allows clinicians to easily grasp the first flap 410.

[0058] Figure 4B The assembly 100 is shown in a second deployed state, with the first flap 410 deployed along the right-side fold line 411. Therefore, in the second deployed state, the first flap 410 extends away from the right side 402 of the assembly 100, such that the first flap 410 includes a portion of the top side 130A with the CSR wrap 130 facing upwards. The corner tabs 410A are also deployed. As shown, the second flap 420 extends across the top side of the assembly 110.

[0059] Figure 4C The assembly 100 is shown in a third deployed state, with the second flap 420 deployed along the proximal fold line 421. Thus, in the third deployed state, the second flap 420 extends away from the proximal side 403 of the assembly 100, such that the second flap 420 defines another portion of the upward-facing top side 130A of the CSR wrap 130. The third flap 430 is shown as an extension across the top side of the assembly 100. A base pad 110 is attached to the third flap 430, while a cover 120 is attached to the base pad 110. Thus, the base pad 110 and the cover 120 (each in a folded state) together with the third flap 430 extend across the top side of the assembly 110.

[0060] Figure 4D The assembly 100 is shown in its fourth deployed state, with the third flap 430 deployed along the distal fold line 431. Thus, in the fourth deployed state, the third flap 430 extends away from the distal side 401 of the assembly 100, such that the third flap 410 defines another portion of the upward-facing top side 130A of the CSR wrap 130. When the base pad 110 and cover 120 are engaged with the third flap 430, the base pad 110 and cover 120 extend away from the distal side of the assembly 100 in their respective folded states. As shown, the fourth flap 440 extends across the top side of the assembly 110.

[0061] Figure 4E The assembly 100 is shown in its fifth unfolded state, with the fourth flap 440 unfolded along the left fold line 441. Thus, in the fifth unfolded state, the fourth flap 440 extends away from the left side 404 of the assembly 100, such that the fourth flap 440 defines another portion of the top side 130A facing upwards of the CSR wrap 130. As shown, in the fifth unfolded state, the CSR wrap 130 is fully unfolded, with the entire top side 130A facing upwards and the entire bottom side 130B facing downwards. The tray 142 containing the surgical articles 140 is uncovered and, in some embodiments, may be positioned substantially centrally on the CSR wrap 130. The base pad 110 and the cover 120 remain in their respective folded states, positioned distal to the tray 142. Each of the base pad 110 and the cover 120 may be folded into a zigzag accordion shape or a rolled-up shape. In some embodiments, when the base pad 130 is folded, the base pad 130 may wrap around the cover 130. In other words, when the base pad 130 is in a folded state, the base pad 130 can cover the cover cloth 130.

[0062] Figure 4F The assembly 100 is shown in its sixth unfolded state, with the base pad 110 unfolded and the cover 120 folded. As shown, with the base pad 110 unfolded, the entire top side 120A faces upward. By unfolding the cover 120, the assembly 100 transitions from the sixth unfolded state. Figure 1A The fully unfolded state.

[0063] Figure 5A Component 100 is shown partially converted to a second folded configuration, which, as described above, may resemble the first folded configuration in some respects. As described above, after use (such as at the end of a procedure), clinicians can convert (i.e., fold) component 100 into the second folded configuration. Figure 5A This is a detailed partial side view of component 100 in a first state folded toward the second fold configuration, the first state being similar to... Figure 4F The fifth unfolded state is shown and described accordingly. Figure 5A Details of the base pad 110 are shown in detail. As shown, the base pad 110 is wrapped around the cover 120 to define the base pad / cover assembly 510, in order to encapsulate the cover 120 along with any residue from the process disposed on the cover 120. The base pad 110 is wrapped such that the bottom side 110B, including the bottom sealing layer 313, faces outward. Since the bottom sealing layer 313 defines a liquid seal, any liquid collected by the base pad 110 and / or the cover 120 is encapsulated by the bottom sealing layer 313.

[0064] Figure 5BA near-side view of the base pad / cover assembly 510 in its final folded state (i.e., when component 100 is fully converted to the second folded configuration) is shown. Figure 5A (View from the proximal direction). Although CSR package 130 is present, it is not shown for ease of illustration. Figure 5B As shown in the image. In the process of... Figure 5A After defining the base pad / cover assembly 510 by wrapping the base pad 110 around the cover 120 as shown and described accordingly, the first end 511 of the base pad / cover assembly 510 is folded inward. Subsequently, the second end 512 is also folded inward over the top of the first end 511. The inward folding of the first end 511 and the second end 512 further encapsulates any residue, including liquid collected within the base pad 110, through the bottom sealing layer 313 of the base pad 110. It should be noted that the bottom sealing layer 313 of the base pad 110 extends around the peripheral edge of the base pad 110, as shown... Figure 3 As shown. Therefore, the bottom sealing layer 313 defines a sealing layer at the first end 511A and the second end 512A of the first end 511 and the second end 512, respectively.

[0065] Figure 6 An assembly 100 is shown inserted below the pelvic region 252 of a patient 250 according to some embodiments. As shown, a base pad 110 is attached to a cover 120 at a first attachment patch 112. The cover 120 may be arranged wholly or partially in a first folded configuration as shown, or the cover 120 may be converted from the first folded configuration. The cover 120 and the base pad 110, attached together at the first attachment patch 112, form a pocket 605 configured to receive one or more fingers 610 of a clinician. Thus, the clinician may apply a distally oriented force 620 to the pocket 605 to displace the base pad 110 (which may include a portion of the cover 120) distally below the pelvic region 252. By placing the fingers 610 in the pocket 605, the cover 120 is positioned between the fingers 610 and the patient 250, thereby preventing direct contact between the fingers 610 and the patient 250's skin.

[0066] Figure 7This is a block diagram of a method using the sterile drape assembly shown and described above. Method 700 can be performed by a medical clinician in conjunction with a urinary catheterization procedure (procedure) on a patient, where the patient may be female or male. Method 700 may include all or any subset of the following steps, actions, or procedures. Method 700 may include providing a drape assembly in a first folded configuration to prepare for a urinary catheterization procedure on a patient (box 705), and unfolding the wrapping of the drape assembly (box 710) to expose the base pad of the drape assembly. In some embodiments of method 700, unfolding the wrapping includes exposing a tray enclosed within the drape assembly in the first folded configuration, wherein the tray contains at least one of a medical device, medical equipment, or supplies to be used during the procedure. In some embodiments of method 700, unfolding the package includes: (i) unfolding a first flap of the package along a first fold line extending along the right side of the cover assembly; (ii) after unfolding the first flap, unfolding a second flap of the package along a second fold line extending along the proximal side of the cover assembly; (iii) after unfolding the second flap, unfolding a third flap of the package along a third fold line extending along the distal side of the cover assembly, wherein a base pad is attached to the third flap; and after unfolding the third flap, unfolding a fourth flap of the package along a fourth fold line extending along the left side of the cover assembly.

[0067] Method 700 may further include unfolding a base pad (frame 715), wherein the base pad is attached to the drape. Method 700 may further include placing the base pad under the patient (frame 720). Method 700 may further include: unfolding a drape assembly (frame 725), wherein the drape is attached to the base pad; and placing the drape over the patient's pelvic region such that the opening of the drape is positioned over the patient's genital region (frame 730). Method 700 may further include attaching the drape to the patient via a plurality of adhesive patches.

[0068] Method 700 may further include folding a diaphragm over the base pad after performing the catheter placement procedure (box 735). Method 700 may further include folding the base pad such that (i) the diaphragm is enclosed by the base pad, and (ii) the fluid-absorbing layer of the base pad is enclosed by a bottom sealing layer of the base pad (box 740). Method 700 may further include folding the wrapping to define a second folded configuration of the diaphragm assembly (box 745). In some embodiments of method 700, folding the wrapping includes enclosing the base pad within the wrapping. In some embodiments of method 700, folding the wrapping includes enclosing a tray within the wrapping, wherein the tray contains at least one of a medical device, medical equipment, or article of manufacture used during the catheter placement procedure. In some embodiments of method 700, folding the package to define a second fold configuration includes: (i) folding a fourth wing inward along a fourth fold line; (ii) folding a third wing inward along a third fold line after folding the fourth wing; and (iii) folding a second wing inward along a second fold line after folding the third wing; and (iv) folding a first wing inward along a first fold line after folding the second wing.

[0069] Figure 8 This is a plan view of another embodiment of the aseptic drape assembly (assembly) 800, which in some respects may resemble a combination Figures 1A to 6 The components of component 100 are described. It should be understood that all illustrated embodiments may have similar features. Therefore, the relevant disclosures regarding the features of similar identifiers described above will not be repeated below. Furthermore, in Figures 1A to 6 Specific features of component 100 and related parts shown in the drawings may not be shown in the drawings or identified by reference numerals, or may not be specifically discussed in the following written description. However, such features may obviously be the same as or substantially the same as features depicted in other embodiments and / or described with respect to such embodiments. Therefore, the relevant description of such features also applies. Figure 8 The characteristics of component 800. Relative to Figures 1A to 6 Any suitable combination and variation of the features described in the component 100 and related parts shown herein can be used with Figure 8 Use it together with component 200.

[0070] Figure 8Component 800 in an unfolded configuration is shown. Component 800 includes a base pad 810, a cover 820, and a CSR wrap 830 integrally formed from a single piece of material 805. Thus, the base pad 810, cover 820, and CSR wrap 830 comprise the base pad portion, cover portion, and CSR wrap portion of the single piece 805. In some embodiments, the single piece 805 may include the material of the aforementioned CSR wrap 130. However, other materials may be considered, as will be understood by those skilled in the art. Component 800 may be used with method 700, including any suitable subset of its steps, actions, or processes.

[0071] While specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise to those skilled in the art, and are also encompassed in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein. In other words, various modifications and improvements to the embodiments specifically disclosed in the foregoing description are within the scope of the appended claims.

Claims

1. A sterile drape assembly, comprising: A sterile drape, including a window, is configured to be placed over the patient's pelvic region during a urinary catheterization procedure; Central Supply Room (CSR) packages; and A base pad, which connects the cover and the wrapping material, The component is capable of switching between a first folded configuration and an unfolded configuration.

2. The component of claim 1, wherein in the unfolded configuration: The cover extends distally away from the base pad, and The package extends proximally away from the base.

3. The component according to claim 1 or 2, wherein the opening is configured to allow access to the patient's genitals through the cover when the cover is placed over the pelvic region.

4. The component according to any one of the preceding claims, wherein the drape comprises a plurality of adhesive patches configured to secure the drape to the patient during the procedure.

5. The component according to any one of the preceding claims, wherein the base pad is configured to be placed under the pelvic region of the patient.

6. The component according to any one of the preceding claims, wherein in the first folded configuration, the cover and the base pad are enclosed by the wrapping material.

7. The component according to any one of the preceding claims, wherein in the first folded configuration, the cover is enclosed by the base pad.

8. The component according to any one of the preceding claims further comprises: A tray that holds at least one of the instruments, equipment, or supplies to be used during the procedure. In the first folding configuration, the tray is enclosed by the package.

9. The component according to any one of the preceding claims further includes a strap configured to wrap around the component and secure the component in the first folded configuration.

10. The component of claim 9, wherein the band includes a marker indicating the orientation of the component when the component is converted to the unfolded configuration.

11. The component according to any one of the preceding claims, wherein the component is configured to change from the unfolded configuration to a second folded configuration such that the cover and the base pad are enclosed by the wrapping material.

12. The component according to any one of the preceding claims, wherein the cover, the base pad, and the wrapping are integrally formed as a single material.

13. The component according to any one of claims 1 to 11, wherein the cover, the base pad, and the wrapping are formed as separate components attached to each other.

14. The component of claim 13, wherein the cover, the base pad, and the wrapping are separately attachable to each other, such that any one of the cover, the base pad, or the wrapping is configured for separate use from the other two.

15. The assembly of claim 13 or 14, wherein the cover fabric is attached to the base pad on the top surface of the base pad such that, in the unfolded configuration, the proximal segment of the cover fabric overlaps with the base pad.

16. The component according to any one of claims 13 to 15, wherein the base pad is attached to the package on the top surface of the package such that, in the unfolded configuration, the proximal segment of the base pad overlaps with the distal segment of the package.

17. The component of claim 16, wherein the distal segment of the package includes a triangular corner segment of the package.

18. The component of any one of claims 13 to 17, wherein the base pad includes a sealing layer disposed across the bottom side of the base pad and a liquid-absorbing layer disposed on top of the sealing layer, the liquid-absorbing layer being configured to collect liquid associated with the procedure.

19. The component of claim 18, wherein in the second folded configuration, the absorbent layer is encapsulated by the sealing layer.

20. A method of using a sterile drape assembly, comprising: The drape assembly is provided in a first folded configuration to prepare for performing a urinary catheter placement procedure on a patient, the drape assembly being placed in front of the patient's pelvic region; Unfold the cover of the cover assembly to expose the base pad of the cover assembly; Unfold the bottom pad of the cover assembly, the bottom pad being attached to the package; The base pad is placed under the patient's pelvic region; Unfold the cover of the cover assembly, and attach the cover to the base pad; as well as The drape is placed over the patient's pelvic region, such that the opening of the drape is positioned over the patient's genital region.

21. The method of claim 20, wherein unfolding the package includes exposing a tray enclosed within the cover assembly in the first folded configuration, and the tray contains at least one of a medical device, medical equipment, or supplies to be used during the procedure.

22. The method of claim 20 or 21, wherein unfolding the package comprises: Unfold the first flap of the package along the first fold line, which extends along the right side of the cover assembly; After the first flap is unfolded, the second flap of the wrapping is unfolded along the second fold line, which extends along the proximal side of the cover assembly; After the second flap is unfolded, the third flap of the package is unfolded along the third fold line, which extends along the distal side of the cover assembly, wherein the base pad is attached to the third flap; as well as After the third flap is unfolded, the fourth flap of the wrapping is unfolded along the fourth fold line, which extends along the left side of the cover assembly.

23. The method according to any one of claims 20 to 22, wherein placing the base pad under the patient comprises: Insert one or more fingers into the pocket formed by the cover attached to the base pad; When the cover is positioned between the fingers and the patient, a distally oriented force is applied to the pocket to displace the bottom pad distally under the patient, thereby preventing direct contact between the fingers and the patient's skin.

24. The method of any one of claims 20 to 23, further comprising attaching the drape to the patient via a plurality of adhesive patches of the drape.

25. The method according to any one of claims 20 to 24, further comprising: After performing the procedure, fold the cover over the top of the base pad.

26. The method of claim 25, further comprising: Fold the base pad such that (i) the cover is enclosed within the base pad, and (ii) the liquid-absorbing layer of the base pad is enclosed by the bottom sealing layer of the base pad.

27. The method according to claim 24 or 25, further comprising: The wrapping is folded to define a second folded configuration of the cover assembly.

28. The method of claim 27, wherein folding the package includes enclosing the base pad within the package.

29. The method of claim 27 or claim 28, wherein folding the package includes enclosing the tray, the tray containing at least one of a medical device, medical equipment, or supplies used during the procedure.

30. The method according to any one of claims 27 to 29, wherein folding the package comprises: Fold the fourth wing inward along the fourth fold line; After folding the fourth wing, fold the third wing inward along the third fold line; as well as After folding the third wing, fold the second wing inward along the second fold line; as well as After folding the second winglet, fold the first winglet inward along the first fold line.

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