EP4788253A1 - Folded sterile drape assembly - Google Patents

Abstract

A sterile drape assembly includes a surgical drape configured for placement over a pelvic region of a patient during a urinary catheter placement procedure. The drape includes a fenestration configured for placement over a genital region of the patient. An underpad, configured for placement beneath a pelvic region of the patient, is attached to the drape and a central supply room (CSR) wrap to define the assembly. The assembly is transitionable from an initial folded state to an unfolded state. A tray containing medical instruments and/or supplies is enclosed by the assembly in the folded state. Adhesive patches on the drape attach the drape to the patient. The assembly is also transitionable from the unfolded state to a final folded state post the procedure.

Description

FOLDED STERILE DRAPE ASSEMBLY

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/545,713, filed October 25, 2023, which is incorporated by reference in its entirety into this application.

BACKGROUND

[0002] Medical errors including human errors continue to be a leading causes of poor patient outcomes or other complications related to medical procedures within a patient care environment. Lack of attention or distractions during a medical procedure can often result in a breach of a sterile environment which can result in hospital acquired infections. The number of tasks and/or the number medical components associated with a medical procedure can be linked to the occurrence rate of hospital acquired infections or other complications related to a sterility breach. Currently, the workflow for establishing a sterile working area for an aseptic urinary catheter (e.g., a Foley® catheter) insertion technique involves multiple steps and multiple components, such as a C SR Wrap, and underpad, and a fenestrated drape that need to be located and placed without contaminating the sterile working area. Such multiple steps and multiple components, represent a large neural load on nurses in an already busy environment that can cause lapses in aseptic technique.

[0003] Disclosed herein are systems, devices, and methods that reduce the number of steps and components associated with aseptic technique during placement of medical devices within a patient, including Foley® catheters.

SUMMARY

[0004] Briefly summarized, embodiments disclosed herein are directed to a sterile drape assembly for use during a medical procedure, specifically the insertion of a urinary catheter. The sterile drape assembly includes a combination of components utilized to establish a sterile environment for the catheterization procedure which in the absence of the sterile drape assembly can be used individually to establish a sterile environment.

[0005] Disclosed herein is a sterile drape assembly that, according to some embodiments, includes (i) a sterile drape having a fenestration, where the drape is configured for placement over a pelvic region of a patient during a urinary catheter placement procedure; (ii) a central supply room (CSR) wrap; and (iii) an underpad coupled between the drape and the wrap. The sterile drape assembly is transitionable between a first folded configuration and an unfolded configuration.

[0006] In some embodiments, the fenestration is configured to enable access to the genitals of the patient when the drape is placed over the pelvic region, and in some embodiments the drape includes a number of adhesive patches configured to secure the drape to the patient during the urinary catheter placement procedure.

[0007] In some embodiments, the underpad includes a sealing layer disposed across an underside of the underpad and a liquid absorbing layer disposed on top of the sealing layer. In some embodiments, the underpad is configured for placement beneath the pelvic region of the patient during the urinary catheter placement procedure, and the liquid absorbing layer is configured collect liquids associated with the urinary catheter placement procedure.

[0008] In some embodiments, the drape is attached to the underpad along proximal perimeter edge of the drape, and the underpad is attached to the wrap along a proximal perimeter edge of the underpad. In some embodiments, the drape is attached to the underpad such that the drape extends distally away from the underpad in the unfolded configuration. In some embodiments, the drape is attached to the underpad on a top surface of the underpad such that a proximal section of the drape overlaps the underpad in the unfolded configuration. In some embodiments the wrap is attached to the underpad such that the wrap extends proximally away from the underpad in the unfolded configuration. In some embodiments, the underpad is attached to the wrap on a top surface of the wrap such that a proximal section of the underpad overlaps a distal section the wrap in the unfolded configuration. In some embodiments, the distal section of the wrap includes a triangular corner section of the wrap.

[0009] In some embodiment, the drape and the underpad are enclosed by the wrap in the first folded configuration. In some embodiments, the drape is enclosed by the underpad in the first folded configuration.

[0010] In some embodiments, the assembly further includes a tray containing a number instruments, devices, or supplies to be utilized during the urinary catheter placement procedure, wherein the tray is enclosed by the wrap in the first folded configuration. [0011] In some embodiments, the assembly further includes a band configured to secure the assembly in the first folded configuration. In some embodiments, the band includes an indicium indicating an orientation of the assembly when the assembly is transitioned to the unfolded configuration.

[0012] In some embodiments, the assembly is configured to transition from the unfolded configuration to a second folded configuration such that the drape and the underpad are enclosed by the wrap. In some embodiments, in the second folded configuration that the absorbing layer is enclosed by the sealing layer.

[0013] Also disclosed herein is a method of using a sterile drape assembly that, according to some embodiments, includes providing a drape assembly in a first folded configuration in preparation for performing a urinary catheter placement procedure on a patient. The method further includes unfolding a wrap of the drape assembly, thereby exposing an underpad of the drape assembly, and unfolding the underpad of the drape assembly, where the underpad is attached to the wrap. The method further includes (i) placing the underpad beneath a patient; (ii) unfolding a drape of the drape assembly, where the drape is attached to the underpad; and (iii) placing the drape over a pelvic region of the patient such that a fenestration of the drape is positioned over a genital region of the patient.

[0014] In some embodiments of the method, unfolding the wrap includes exposing a tray enclosed within the drape assembly in the first folded configuration, where the tray contains at least one of medical instruments, medical devices, or supplies to be used during the catheter placement procedure.

[0015] In some embodiments of the method, unfolding the wrap includes (i) unfolding a first flap of the wrap along a first fold line extending along a right side of the drape assembly; (ii) unfolding a second flap of the wrap along a second fold line extending along a proximal side of the drape assembly after unfolding the first flap; (iii) unfolding a third flap of the wrap along a third fold line extending along a distal side of the drape assembly after unfolding the second flap, where the underpad is attached the third flap; and unfolding a fourth flap of the wrap along a forth fold line extending along a left side of the drape assembly after unfolding the third flap. In some embodiments, the method further includes attaching the drape to the patient via a number of adhesive patches of the drape. [0016] In some embodiments, the method further includes folding the drape atop the underpad after the catheter placement procedure is performed. In some embodiments, the method further includes folding the underpad such that (i) the drape is enclosed by the underpad and (ii) a liquid absorbing layer of the underpad is enclosed by a bottom sealing layer of the underpad.

[0017] In some embodiments, the method further includes folding the wrap to define a second folded configuration of the drape assembly. In some embodiments of the method, folding the wrap includes enclosing the underpad within the wrap. In some embodiments of the method, folding the wrap includes enclosing a tray of medical instrument or procedural supplies within the wrap.

[0018] In some embodiments of the method, folding the wrap to define the second folded configuration includes (i) folding the fourth flap inward along the forth fold line; (ii) folding the third flap inward along the third fold line after folding the fourth flap; and (iii) folding a second flap inward along the second fold line after folding the third flap; and (iv) folding a first flap inward along the first fold line after folding the second flap.

[0019] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

BRIEF DESCRIPTION OF DRAWINGS

[0020] FIG. 1A illustrates a sterile drape assembly in an unfolded configuration, according to some embodiments disclosed herein.

[0021] FIG. IB illustrates the assembly of FIG. 1A in a first folded configuration, according to some embodiments disclosed herein.

[0022] FIG. 2 A illustrates a plan view of the assembly of FIG. 1 A in use with a patient, according to some embodiments disclosed herein.

[0023] FIG. 2B illustrates a side view of the assembly of FIG. 1 A in use with a patient, according to some embodiments disclosed herein.

[0024] FIG. 3 illustrates a detailed cross-sectional view of a portion of the underpad of the assembly of FIG. 1A, according to some embodiments disclosed herein. [0025] FIGS. 4A-4F illustrate the assembly of FIGS. 1A-1B in various stages of transitioning from the first folded configuration of FIG. IB to the unfolded configuration of FIG. 1 A, according to some embodiments disclosed herein.

[0026] FIG. 5 A illustrates a side view of the assembly of FIGS. 1 A-1B in a first folded state during transitioning of the assembly toward a second folded configuration, according to some embodiments disclosed herein.

[0027] FIG. 5B illustrates a proximal view of a combination of the underpad and the drape of the assembly of FIG. 5 A in a second folded state during transitioning of the assembly toward the second folded configuration, according to some embodiments disclosed herein.

[0028] FIG. 6 illustrates a side view of the assembly of FIG. 1A during placement of the underpad beneath the patient, according to some embodiments disclosed herein.

[0029] FIG. 7 is a block diagram of a method of using the assembly of FIGS. 1A-1B, according to some embodiments disclosed herein.

[0030] FIG. 8 illustrates another embodiment of a sterile drape assembly in an unfolded configuration, according to some embodiments disclosed herein.

DESCRIPTION

[0031] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0032] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0033] The terms “proximal” and “distal” refer to opposite ends or 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 nearest a clinician during use, while the distal portion is the portion at the opposite end. For example, the proximal portion of an underpad is defined as the portion closest to the clinician during utilization of the sterile drape assembly. The distal portion is the portion opposite the proximal portion, e.g., the portion placed beneath a pelvis of the patient.

[0034] References to approximations may be made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” or “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0035] The phrases “connected to” or “coupled with,” refer to any form of interaction between two or more entities, including but not limited to mechanical and fluid interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component. The phrase “attached to” refers to a direct physical connection between two components.

[0036] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and/or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0037] FIG. 1 A is a plan view of a sterile drape assembly (assembly) 100. The assembly 100 is generally configured for use by a clinician during a urinary catheter (e.g., a Foley® catheter) placement procedure (procedure) for a patient. The assembly 100 is configured to transition between a folded configuration (see FIG. IB) and an unfolded configuration a shown in FIG. 1A. In an embodiment, the assembly 100 may be initially disposed in a first folded configuration and then transitioned to the unfolded configuration during use, such as during application to the patient, for example.

[0038] In one embodiment, the assembly 100 may be assembled and initially disposed in (i.e., folded into) the first folded configuration at a manufacturing location for the assembly 100 and provided to a healthcare facility in the first folded configuration. In some embodiments, the assembly 100 may be sterilized in the first folded configuration. In an alternative embodiment, individual components of the assembly 100 may be provided to the healthcare facility. In accordance with this embodiment, the assembly 100 may be assembled and initially disposed in the first folded configuration at the healthcare facility.

[0039] The assembly 100 may be provided in a single size configured for use with patients of all sizes. Alternatively, the assembly 100 may be provided with one or more components chosen from a plurality of different sizes, where the different sizes are configured to be used with patients of different sizes and/or shapes. The assembly 100 may be sex neutral, i.e., configured for use with either female or male patients. In other embodiments, the assembly 100 may include a female version that is different from a male version.

[0040] The assembly 100 generally includes at least three components that are packaged together. The three components include an underpad 110, a central supply room CSR wrap (CSR wrap) 130, and a drape 120. As discussed above, in an embodiment, the underpad 110, the C SR wrap 130, and the drape 120 may constitute separate components. In other words, any one of the CSR wrap 130, or the drape 120 may be configured for use as a stand-alone device separate the other components. In another embodiment, two or more of the underpad 110, CSR wrap 130, and the drape 120 may be fixedly attached together. Each of the underpad 110, C SR wrap 130, and the drape 120 define a topside and an underside designated as 110A, HOB, 120A, 120B, 130A, and 130B, respectively. The assembly 100 may also include (although not required) various procedural items 140 to be utilized during the procedure such as disinfectant swabs, catheter components, tools, instruments, syringes, medical solutions, and the like, and the procedural items 140 may be contained within a tray 142.

[0041] FIG. 1 A illustrates an embodiment where the underpad 110, the CSR wrap 130, and the drape 120 are permanently attached to together, such that the underpad 110, the CSR wrap 130, and the drape 120 remain attached to together during the complete use of the assembly 100. In other embodiments, the underpad 110, the CSR wrap 130, and the drape 120 separably attached together so that the any two of the components may be detached from each other and in some embodiments, reattached to together, such as in a different relative location or orientation with respect to each other.

[0042] In the illustrated embodiment, the underpad 110 is attached to the drape 120 via a first attachment patch 112 (e.g., adhesive patch) disposed on the topside 110A of the underpad 110. The first attachment patch 112 is located at a proximal end 129 of the drape 120 and spaced away from a distal end of the underpad 110 such that a proximal section 129A of the drape 120 overlaps a distal section 115 of the underpad 110. Attaching the proximal end 129 of the drape 120 to the location spaced away from the distal end of the underpad 110 may be advantageous in a number of ways as described below. Although in other embodiments, the first attachment patch 112 may located a distal end of the underpad 110 such that the underpad 110 and the drape 120 do not overlap in the unfolded configuration.

[0043] The underpad 110 is generally configured for placement beneath a pelvic region of the patient (i.e., between the patient and an examination table or bed surface) during the procedure. One functionality of the underpad 110 inter alia is catching and containing any liquids associated with the procedure, such as cleaning, disinfecting, or body liquids, for example. The underpad 110 may include a rectangular shape, although other shapes are considered, such as a square, round, oval, or trapezoidal shape, for example. The underpad 110 may also include a perimeter seal which may extend along an entire perimeter of the underpad 110. The perimeter seal is configured to prevent liquid from leaking or seeping from the underpad 110 along the perimeter edge, including the entire perimeter edge. Further details regarding the construction of the underpad 110 including the perimeter seal are shown in FIG.

3 and described therewith.

[0044] The drape 120, generally referred to a surgical drape in the medical industry, is configured to cover a pelvic region of the patient during the procedure. The drape 120 may be formed of a material that is resistant to penetration by liquids and microorganisms, such as polypropylene or polyester, for example. The drape 120 includes a fenestration 122 extending between the topside 120A and the underside 120B. The fenestration 122 is located, shaped, and sized to enable access to the genitals of the patient by the clinician during the procedure. The drape 120 may optionally include a notch 124 extend inward from a distal end of the drape 124, which may be V-shaped. The notch 124 may help in 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 are considered, such as oval, round, square, hourglass, trapezoidal, and the like.

[0045] The drape 120 is configured to attach to the patient during the procedure. As such, the drape 120 may include a number of adhesive patches disposed on an underside 120B of the drape 120. Each of the adhesive patches may include an adhesive conducive to attachment to the skin of the patient, such as a pressure adhesive enable by removal of a backing layer, for example. The drape 120 includes a number (e.g., 1,2, 3 or more) of pelvic adhesive patches 126 located on the drape 120 to facilitate attachment of the drape 120 to the pelvic region of the patient, such as adjacent the distal end of the drape 120, for example. The drape 120 may also optionally include a number (e.g., 1,2, 3 or more) of leg adhesive patches 128 located on the drape 120 to facilitate attachment of the drape 120 to the legs of the patient, such as adjacent the right and left sides of the drape 120, for example.

[0046] The CSR wrap 130 is fabric-like panel generally configured for placement thereon of medical instruments or other items to be used during the procedure. The CSR wrap 130 may be sterilizable via a number of different of sterilizing techniques, such as exposure to steam or an ethyl ene-oxi de gas, for example. Materials of the CSR wrap 130 may include polypropylene or other synthetic materials that are relatively strong so as to resist tearing or puncture during use. In some embodiments, the material may include a cellulose material configured to prevent skin irritation. Other material features may include air permeability and low-lint properties. The material of the CSR wrap 130 may include a woven or non-woven fabric. In the illustrated embodiment, the CSR wrap 130 includes a square shape. However, the CSR wrap 130 is not limited to a square shape. Other shapes are considered, such as rectangular, trapezoidal, and the like.

[0047] In the illustrated embodiment, the underpad 110 is attached to the CSR wrap 130 via a second attachment patch 113 (e.g., adhesive patch) disposed between the underside HOB of the underpad 110 and the topside 130A of the CSR wrap 130. The second attachment patch 113 is located at a proximal end of the underpad 110 and spaced away from a distal end 134 (i.e., a corner tip) of the CSR wrap 130 such that a proximal portion of the underpad 110 overlaps a triangular distal section 135 of the CSR wrap 130. Attaching the proximal end of the underpad 110 to the location spaced away from the distal end of the CSR wrap 130, may be advantageous in a number of ways as described below.

[0048] FIG. IB illustrates the assembly 100 in the first folded configuration. The assembly 100 may be configured for storage in the first folded configuration. In some embodiments, the assembly 100 may be enclosed within an outer package (bag or pouch, not shown) in the first folded configuration, where the outer package provides a sterile barrier for the assembly 100 until the assembly 100 is removed from the outer package. The first folded configuration may be defined such that the underside I 30B of the CSR wrap 130 defines an entire outside surface of the assembly 100 in the first folded configuration or in other words, the topside I 30A of the wrap 130 is substantial enclosed by the underside I 30B of the wrap 130.

[0049] The assembly 100 may include a band 105 configured to secure the assembly 100 in the first folded configuration. The band 105 may extend around an entire circumference of the assembly 100 in the first folded configuration. The band 105 may be formed of a material (e.g., paper) that is easily breached to enable to the clinician to transition the assembly 100 from the first folded configuration to the unfolded configuration. By way of one example, the band 105 may include a first end 105 A that overlaps a second end 105B where 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 105 A may be reattached to the second end 105B via the adhesive patch 105C at a later time, such as after the procedure, for example. Although not shown, the band 105 may be attached to the underside I 30B of the CSR wrap 130 along an underside of the assembly 100 in the first folded configuration, which may remain attached to the underside BOB of the CSR wrap 130 when the assembly 100 is transitioned to the unfolded configuration and during the procedure. [0050] The band 105 may include one or more indicia or text. The band 105 may include an indicium 106 (e.g., an arrow) indicating an orientation of the assembly 100. For example, the indicium 106 may indicate an intended orientation of the assembly 100 for use so that the assembly 100 is properly oriented with respect to the patient once the assembly 100 is transitioned to the unfolded configuration. Such an indicum 106 may prevent the clinician from needing to reorient the assembly 100 after the assembly 100 is transitioned or partially transitioned from the first folded configuration toward the unfolded configuration. The band 105 may also include textual information 107, such as instructions for use, for example.

[0051] The assembly 100 may be configured for transition into (i.e., be folded into) a second folded configuration (not shown) after use of the assembly 100, where the second folded configuration may in some respects resemble the first folded configuration. The second folded configuration may be configured to retain any collected liquids with a sealing layer of the underpad 110 as further described below. As such, the clinician may dispose of the used assembly 100 without concern for any collected liquids leaking out of the assembly 100 in the second folded configuration. The second folded configuration may be further configured to accommodate and retain any disposable items used in the catheter placement procedure, such as gloves, disposable tools, disposable tools, catheter components, or packaging, including the tray 142 and the procedural items 140, for example. As such, the assembly 100 in the second folded configuration may constitute a safe and effective mechanism or method fortransporting any or all disposable items used in the procedure, which items may be biohazardous, from the point of use to a point of disposal for used medical supplies.

[0052] FIGS. 2 A, 2B illustrate the assembly 100 in use with a patient. FIG. 2 A illustrates a top view of a patient 250 (male or female) including a pelvic region 252 and genital region 254. The assembly 100 is shown in use with the patient 250, where the underpad 110 is placed beneath the pelvic region 252 and the CSR wrap 130 is placed in front of the patient 250 such as between the legs of the patient 250. The tray 142 containing the procedural items 140 is placed on the topside 130A of the CSR wrap 130. The drape 120 is applied to the pelvic region 252 such that the fenestration 122 is applied over the genital region 254. The pelvic adhesive patches 126 are attached to the pelvic region 252 and the leg adhesive patches 128 are attached to the legs (e.g., inner thighs) of the patient 250.

[0053] FIG. 2B illustrates a side view of the patient 250 during use of the assembly 100. The right leg of the patient 250 and a portion of the right arm are removed for convenience in illustration. The underpad 110 is shown disposed beneath the pelvic region 252 and the CSR wrap 130 is shown in front of the patient 250 having the tray 140 containing the procedural items 140 placed atop the CSR wrap 130. The drape 120 is shown covering the pelvic region 252 with the fenestration 122 positioned over the genital region 254. The pelvic adhesive patch 126 is shown securing the drape 120 to a skin surface of the pelvic region 252 and the leg adhesive patch 128 is shown securing the drape 120 to a skin surface of the left leg of the patient 250. In some instances, the proximal portion 129A including the proximal end 129 of the drape 120 may be disposed beneath the pelvic region 252.

[0054] FIG. 3 is a cross sectional view of a portion of the underpad 110 cut along the sectioning line 3-3 as shown in FIG. 1A. The underpad 110 may include a number (e.g., 1, 2, 3 or more) layers where the different layers define different functionalities of the underpad 110. By way of one example, the underpad 110 may include a top layer 311, a middle absorbing layer 312 and a bottom sealing layer 313. The top layer 311 is generally configured for skin contact with the patient 250. As such, the top layer 311 may provide padding to aid in patient comfort during the procedure. The top layer 311 may also enable passage of liquid (shown as arrow 303) through the top layer 311 to the middle absorbing layer 312. In some embodiments, the top layer 311 may include a spun-bound polypropylene material. The middle absorbing layer 312 is generally configured to receive liquid 303 from the top layer 311 and absorb the liquid 303. As such, the middle absorbing layer 312 in combination with the top layer 311 may aid in minimizing contact of the liquid 303 with the patient 250. In some embodiments, the middle absorbing layer 312 may be formed of a cellulose material configured for absorption of the liquid 303. The bottom sealing layer 313 is configured to provide a liquid seal along the underside HOB of the underpad 110 so that the liquid 303 absorbed by the middle layer 312 remains contained within the underpad 110. The bottom sealing layer 313 may be formed of any suitable sealing material typically used for such purposes, such as a plastic film, for example. As discussed above, the underpad 110 may include a perimeter seal 308. By way of one example, the perimeter seal 308 may be formed by extending the bottom sealing layer 313 upward around the perimeter edge 305 and inward from the perimeter edge 305 along the topside 110A of the underpad 110.

[0055] FIGS. 4A-4F illustrate the assembly 100 is various states transitioning between the first folded configuration and the unfolded configuration. The various states are illustrated in sequential states of unfolding, which in the reverse order may illustrate the assembly 100 in sequential states of transitioning from the unfolded configuration to the first folded configuration. It is noted that the illustrated states of folding/unfolding represent one exemplary process of folding/unfolding of the assembly. Other states, processes, or methods of folding/unfolding are considered as may be appreciated by one of ordinary skill.

[0056] FIG. 4A illustrates the assembly 100 in a first unfolded state, where the band 105 is separated to allow further unfolding the assembly 100. The band 105 is attached to an underside of the assembly 100, i.e., the underside 130B of a portion of the CSR wrap 130 disposed across the underside of the assembly 100 in the first folded configuration. For the purposes of illustration, the assembly 100 defines a distal side 401, a right side 402, a proximal side 403, and a left side 404. It is noted that the underside 130B of the CSR wrap 130 defines a substantially entire outside surface of the assembly 100 in the first folded configuration. As shown in FIG. 4A, a first flap 410 extends across a topside (i.e., the side facing away from the page) of the assembly 100. In some embodiments, the first flap 410 may include a corner tab 410 folded back over the first flap 410. The comer tab 410A may enable the clinician to easily grasp the first flap 410.

[0057] FIG. 4B illustrates the assembly 100 in a second unfolded state, where the first flap 410 is unfolded along a right-side fold line 411. As such, in the second unfolded state, the first flap 410 extends away from the right side 402 of the assembly 100 such that first flap 410 includes a portion of the topside 130A of CSR wrap 130 facing upward. The comer tab 410A is also unfolded. As shown, a second flap 420 extends across the topside of the assembly 110.

[0058] FIG. 4C illustrates the assembly 100 in a third unfolded state, where the second flap 420 is unfolded along a proximal-side fold line 421. As such, in the third unfolded state, the second flap 420 extends away from the proximal side 403 of the assembly 100 such that second flap 420 defines another portion of the topside 130A of CSR wrap 130 facing upward. A third flap 430 is shown extending across the topside of the assembly 100. The underpad 110 is attached to third flap 430 with the drape 120 attached the underpad 110. As such, the underpad 110 and the drape 120, each in the folded state, extend along with the third flap 430 across the topside of the assembly 110.

[0059] FIG. 4D illustrates the assembly 100 in a fourth unfolded state, where the third flap 430 is unfolded along a distal-side fold line 431. As such, in the fourth unfolded state, the third flap 430 extends away from the distal side 401 of the assembly 100 such that third flap 410 defines another portion of the topside 130A of CSR wrap 130 facing upward. As the underpad 110 and the drape 120 are coupled with the third flap 430, the underpad 110 and the drape 120 extend away from the distal side of the assembly 100 in their respective folded states. As shown, a fourth flap 440 extends across the topside of the assembly 110.

[0060] FIG. 4E illustrates the assembly 100 in a fifth unfolded state, where the fourth flap 440 is unfolded along a left-side fold line 441. As such, 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 topside 130A of CSR wrap 130 facing upward. As shown, in the fifth unfolded state the CSR wrap 130 is completely unfolded such an entire topside 130A is facing upward and an entire underside 130B is facing downward. The tray 142 containing the procedural items 140 is uncovered, and in some embodiments may be positioned substantially centrally on the CSR wrap 130. The underpad 110 and the drape 120 remain in their respective folded states positioned distal the tray 142. Each of the underpad 110 and the drape 120 may be folded in either a zig-zag accordion fashion or a rolled-up fashion. In some embodiments, the underpad 130 may wrap around drape 130 when the underpad 130 is in the folded state. Said another way, the underpad 130 may enclose drape 130 when the underpad 130 is in the folded state.

[0061] FIG. 4F illustrates the assembly 100 in a sixth unfolded state, where the underpad 110 is unfolded and the drape 120 remains folded. As shown, with the underpad 110 unfolded, the entire topside 120A faces upward. The assembly 100 is transitioned from the sixth unfolded state to the fully unfolded state of FIG. 1 A by unfolding the drape 120.

[0062] FIG. 5 A illustrates the assembly 100 partially transitioned toward the second folded configuration which, as discussed above, may in some respects resemble the first folded configuration. As discussed above, the clinician may transition (i.e., fold) the assembly 100 into the second folded configuration after use, such as at the conclusion of the procedure. FIG. 5 A is a detailed partial side view of the assembly 100 in a first state of folding toward the second folded configuration that is similar to the fifth unfolded state shown in FIG. 4F and described therewith. FIG. 5 A specifically illustrates details of the underpad 110. As shown, the underpad 110 is wrapped around the drape 120 to define an underpad/drape combination 510 so as to encapsulate the drape 120 along with any residue from the procedure disposed on the drape 120. The underpad 110 is wrapped such that the underside HOB including the bottom sealing layer 313 faces outward. As the bottom sealing layer 313 defines a liquid seal, any liquid collected by the underpad 110 and/or the drape 120 is encapsulated by the bottom sealing layer 313.

[0063] FIG. 5B illustrates a proximal view (i.e., a view in the proximal direction of FIG. 5 A) of the underpad/ drape combination 510 in a final folded state, i.e., when the assembly 100 is fully transitioned to the second folded configuration. The CSR wrap 130, although present, is not shown in FIG. 5B for convenience in illustration. After defining the underpad/ drape combination 510 by wrapping the underpad 110 around the drape 120 as shown in FIG. 5 A and described therewith, a first end portion 511 of the underpad/ drape combination 510 is folded inward. Thereafter, a second end portion 512 is also folded inward atop the first end portion 511. The folding inward of the first and second end portions 511, 512 further encapsulates any residue including collected liquid within the underpad 110 by the bottom sealing layer 313 of the underpad 110. It is noted that the bottom sealing layer 313 of the underpad 110 extends around the perimeter edges of the underpad 110 as shown in FIG. 3. As such, the bottom sealing layer 313 defines the sealing layer at the first and second ends 511 A, 512A of the first and second end portions 511, 512, respectively.

[0064] FIG. 6 illustrates the assembly 100 being inserted beneath the pelvic region 252 of the patient 250, according to some embodiments. As shown, the underpad 110 is attached to the drape 120 at the first attachment patch 112. The drape 120 may be completely or partially disposed in the first folded configuration as shown, or the drape 120 may be transitioned away from the first folded configuration. The drape 120 and the underpad 110 attached together at the first attachment patch 112 creates a pocket 605 that is configured to receive one or more fingers 610 of the clinician. As such, the clinician may exert a distally oriented force 620 to the pocket 605 to distally displace the underpad 110, which may include a portion of the drape 120, beneath the pelvic region 252. By placing the fingers 610 in the pocket 605, the drape 120 is disposed between the fingers 610 and the patient 250, thereby preventing direct contact of the fingers 610 with the skin of the patient 250.

[0065] FIG. 7 is a block diagram of a method of using the sterile drape assembly shown and described above. The method 700 may be performed by a medical clinician in conjunction performing a urinary catheter placement procedure (procedure) on a patient, where the patient may be female or male. The method 700 may include all or any subset of the following steps, actions or processes. The method 700 may include providing the drape assembly in the first folded configuration in preparation for performing the urinary catheter placement procedure on the patient (block 705) and unfolding the wrap of the drape assembly (block 710), thereby exposing the underpad of the drape assembly. In some embodiments of the method 700, unfolding the wrap includes exposing the tray enclosed within the drape assembly in the first folded configuration, where the tray contains at least one of medical instruments, medical devices, or supplies to be used during the procedure. In some embodiments of the method 700, unfolding the wrap includes (i) unfolding the first flap of the wrap along the first fold line extending along the right side of the drape assembly; (ii) unfolding the second flap of the wrap along the second fold line extending along the proximal side of the drape assembly after unfolding the first flap; (iii) unfolding the third flap of the wrap along the third fold line extending along the distal side of the drape assembly after unfolding the second flap, where the underpad is attached the third flap; and unfolding the fourth flap of the wrap along the forth fold line extending along the left side of the drape assembly after unfolding the third flap.

[0066] The method 700 may further include unfolding the underpad (block 715), where the underpad is attached to the wrap. The method 700 may further include placing the underpad beneath the patient (block 720). The method 700 may further include unfolding the drape of the drape assembly (block 725), where the drape is attached to the underpad, and placing the drape over the pelvic region of the patient such that a fenestration of the drape is positioned over the genital region of the patient (block 730). The method 700 may further include attaching the drape to the patient via a number of adhesive patches of the drape.

[0067] The method 700 may further include folding the drape atop the underpad after the catheter placement procedure is performed (block 735). The method 700 may further include folding the underpad such that (i) the drape is enclosed by the underpad and (ii) a liquid absorbing layer of the underpad is enclosed by a bottom sealing layer of the underpad (block 740). The method 700 may further include folding the wrap to define a second folded configuration of the drape assembly (block 745). In some embodiments of the method 700, folding the wrap includes enclosing the underpad within the wrap. In some embodiments of the method 700, folding the wrap includes enclosing the tray within the wrap, where the tray contains at least one of medical instruments, medical devices, or supplies that were used during the catheter placement procedure. In some embodiments of the method 700, folding the wrap to define the second folded configuration includes (i) folding the fourth flap inward along the forth fold line; (ii) folding the third flap inward along the third fold line after folding the fourth flap; and (iii) folding a second flap inward along the second fold line after folding the third flap; and (iv) folding a first flap inward along the first fold line after folding the second flap.

[0068] FIG. 8 is a plan view of another embodiment of a sterile drape assembly (assembly) 800 that can, in certain respects, resemble components of the assembly 100 described in connection with FIGS. 1A-6. It will be appreciated that all the illustrated embodiments may have analogous features. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the assembly 100 and related components shown in FIGS. 1 A-6 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the assembly 800 of FIG. 8. Any suitable combination of the features, and variations of the same, described with respect to the assembly 100 and related components illustrated in FIGS. 1 A-6 can be employed with the assembly 200 of FIG. 8.

[0069] FIG. 8 illustrates the assembly 800 in the unfolded configuration. The assembly 800 includes a underpad 810, a drape 820 and a CSR wrap 830 integrally formed of a single sheet 805 of a material. As such, the underpad 810, a drape 820 and a CSR wrap 830 include an underpad portion, a drape portion, and a CSR wrap portion of the single sheet 805. In some embodiments, the single sheet 805 may include the material of the CSR wrap 130 described above. Although other materials may be considered as appreciated by one of ordinary skill. The assembly 800 may be employed with the method 700 including any suitable subset of the steps, actions, or processes thereof.

[0070] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. A sterile drape assembly, comprising: a sterile drape including a fenestration, the drape configured for placement over a pelvic region of a patient during a urinary catheter placement procedure; a central supply room (CSR) wrap; and an underpad coupled between the drape and the wrap, wherein the assembly is transitionable between a first folded configuration and an unfolded configuration.

2. The assembly according to claim 1, wherein in the unfolded configuration: the drape extends distally away from the underpad, and the wrap extends proximally away from the underpad.

3. The assembly according to claim 1 or claim 2, wherein the fenestration is configured to enable access to the genitals of the patient through the drape when the drape is placed over the pelvic region.

4. The assembly according to any of the preceding claims, wherein the drape includes a number of adhesive patches configured to secure the drape to the patient during the procedure.

5. The assembly according to any of the preceding claims, wherein the underpad is configured for placement beneath the pelvic region of the patient.

6. The assembly according to any of the preceding claims, wherein the drape and the underpad are enclosed by the wrap in the first folded configuration.

7. The assembly according to any of the preceding claims, wherein the drape is enclosed by the underpad in the first folded configuration.

8. The assembly according to any of the preceding claims, further comprising: a tray containing at least one of instruments, devices, or supplies to be used during the procedure, wherein the tray is enclosed by the wrap in the first folded configuration.

9. The assembly according to any of the preceding claims, further comprising a band configured to wrap around and secure the assembly in the first folded configuration.

10. The assembly according to claim 9, wherein the band includes an indicium indicating an orientation of the assembly when the assembly is transitioned to the unfolded configuration.

11. The assembly according to any of the preceding claims, wherein the assembly is configured to transition from the unfolded configuration to a second folded configuration such that the drape and the underpad are enclosed by the wrap.

12. The assembly according to any of the preceding claims, wherein the drape, the underpad, and the wrap are integrally formed as a single piece of material.

13. The assembly according to any one of claims 1-11, wherein the drape, the underpad, and the wrap are formed as separate components attached to each other.

14. The assembly according to claim 13, wherein the drape, the underpad, and the wrap are separably attached to each other, such that any one of the drape, the underpad, or the wrap is configured for use separate from the other two.

15. The assembly according to claim 13 or claim 14, wherein the drape is attached to the underpad on a top surface of the underpad such that a proximal section of the drape overlaps the underpad in the unfolded configuration.

16. The assembly according to any one of claims 13-15, wherein the underpad is attached to the wrap on a top surface of the wrap such that a proximal section of the underpad overlaps a distal section of the wrap in the unfolded configuration.

17. The assembly according to claim 16, wherein the distal section of the wrap includes a triangular corner section of the wrap.

18. The assembly according to any one of claims 13-17, wherein the underpad includes a sealing layer disposed across an underside of the underpad and a liquid absorbing layer disposed on top of the sealing layer, the liquid absorbing layer configured to collect liquids associated with the procedure.

19. The assembly according to claim 18, wherein in the second folded configuration that the absorbing layer is enclosed by the sealing layer.

20. A method of using a sterile drape assembly, comprising: providing the drape assembly in a first folded configuration in preparation for performing a urinary catheter placement procedure on a patient, the drape assembly placed in front of a pelvic region of the patient; unfolding a wrap of the drape assembly exposing an underpad of the drape assembly; unfolding the underpad of the drape assembly, the underpad attached to the wrap; placing the underpad beneath the pelvic region of the patient; unfolding a drape of the drape assembly, the drape attached to the underpad; and placing the drape over the pelvic region of the patient such that a fenestration of the drape is positioned over a genital region of the patient.

21. The method according to claim 20, wherein unfolding the wrap includes exposing a tray enclosed within the drape assembly in the first folded configuration, and the tray contains at least one of medical instruments, medical devices, or supplies to be used during the procedure.

22. The method according to claim 20 or claim 21, wherein unfolding the wrap comprises: unfolding a first flap of the wrap along a first fold line extending along a right side of the drape assembly; unfolding a second flap of the wrap along a second fold line extending along a proximal side of the drape assembly after unfolding the first flap; unfolding a third flap of the wrap along a third fold line extending along a distal side of the drape assembly after unfolding the second flap, wherein the underpad is attached the third flap; and unfolding a fourth flap of the wrap along a forth fold line extending along a left side of the drape assembly after unfolding the third flap.

23. The method according to any one of claims 20-22, wherein placing the underpad beneath a patient includes: inserting one or more fingers into a pocket formed by the attachment of the drape to the underpad; exerting a distally oriented force to the pocket to distally displace the underpad beneath the patient while the drape is disposed between the fingers and the patient, thereby preventing direct contact of the fingers with a skin of the patient.

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

25. The method according to any one of claims 20-24, further comprising: folding the drape atop the underpad after the procedure is performed.

26. The method according to claim 25, further comprising: folding the underpad such that (i) the drape is enclosed within the underpad and (ii) a liquid absorbing layer of the underpad is enclosed by a bottom sealing layer of the underpad

27. The method according to claim 24 or claim 25, further comprising: folding the wrap to define a second folded configuration of the drape assembly.

28. The method according to claim 27, wherein folding the wrap includes enclosing the underpad within the wrap.

29. The method according to claim 27 or claim 28, wherein folding the wrap includes enclosing the tray containing at least one of medical instruments, medical devices, or supplies used during the procedure.

30. The method according to any one of claims 27-29, wherein folding the wrap comprises: folding the fourth flap inward along the fourth fold line; folding the third flap inward along the third fold line after folding the fourth flap; and folding a second flap inward along the second fold line after folding the third flap; and folding a first flap inward along the first fold line after folding the second flap.