EP4698262A2 - Catheter dressing and management system and methods of use - Google Patents

Abstract

A system for managing or containing a portion of a catheter that exits a patient's body. The system may include a first catheter management portion comprising a first surface configured to contact a patient's skin, a second surface opposite the first surface, the second surface configured to face away from a patient's skin when the first surface contacts the patient's skin and a catheter pass-through portion configured to have a proximal end of the catheters passed therethrough to isolate a portion of the proximal end of the catheter from a patient's skin. The system may include one or more cover portions or a pouch configuration configured to cover the catheter when the catheter is not being used for a drainage procedure.

Description

CATHETER DRESSING AND MANAGEMENT SYSTEM AND METHODS OF USE

CROSS REFERENCE TO RELA TED APPLICA TIONS

[001] The present application claims the benefit of priority to U. S. Provisional Application No. 63/462045 entitled “ALL IN ONE DRESSING, CATHETER, AND ALL IN ONE DRESSING CATHETER SYSTEM,” filed on April 26, 2023, and 63/554294 entitled “CATHETER DRESSING AND MANAGEMENT SYSTEM,” filed on 2/16/2024, the entirety of both of which are hereby incorporated by reference in their entirety for all purposes.

TECHNICAL FIELD

[002] This disclosure is related to systems and methods for dressing and/or managing an indwelling catheter.

BACKGROUND

[003] Indwelling catheters are typically used to drain fluid into collection bottles. The drainage catheter is inserted (e.g., in the chest for draining pleural effusions or in the abdomen for ascites) and an end of the drainage catheter stays outside of the body, hidden under a bandage when not in use. To drain, the end of the drainage catheter is connected to a drainage line and negative pressure is used to draw out the bodily fluid. Typically, the dressing procedure of an indwelling catheter involves placement of several separate components (foam pad, gauze, self-adhesive dressing) and some users find it difficult to apply the dressing procedure components without help from another person.

[004] Further, use and maintenance of an indwelling catheter and related drainage system requires a series of clean and/or aseptic steps for pre-drainage, bottle/bag drainage, and postdrainage procedures. These steps are in place to promote care and cleanliness of the catheter. The steps required for pre-drainage and post-drainage, especially dressing and/or securing of the exit point of an indwelling catheter can be difficult to manage with only two hands.

SUMMARY

[005] The following presents a simplified summary of one or more aspects of the technology disclosed herein in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later. [006] Disclosed herein is a system for managing or containing a portion of a catheter that exits a patient’s body. The system includes a first catheter management portion comprising a first surface configured to contact a patient’s skin, a second surface opposite the first surface, the second surface configured to face away from a patient’s skin when the first surface contacts the patient’s skin and a catheter pass-through portion configured to have a proximal end of the catheter passed therethrough to isolate a portion of the proximal end of the catheter from a patient’s skin. The system may include one or more cover portions configured to cover the catheter when the catheter is not being used for a drainage procedure.

[007] In another aspect disclosed herein, a system for removably connecting a first portion of a catheter to a second portion of a catheter is disclosed, wherein a first containment portion is configured to releasably contain one of the first portion and the second portion of the catheter.

[008] To the accomplishment of the foregoing and related ends, the one or more aspects of the disclosure comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail include certain illustrative features of the one or more aspects. These features are indicative, however, of but a few of the various ways in which the principles of various aspects can be employed, and this description is intended to include all such aspects and their equivalents.

BRIEF DESCRIPTION OF THE DRA WINGS

[009] Features characteristic of aspects of the technology described herein are set forth as follows, in the appended claims, and in the drawings. In the descriptions that follow, like parts are marked throughout the specification and drawings with the same numerals, respectively. The drawing figures are not necessarily drawn to scale and certain figures can be shown in exaggerated or generalized form in the interest of clarity and conciseness. The disclosure itself, however, as well as a preferred mode of use, further objects and advances thereof, will be best understood by reference to the following detailed description of illustrative aspects when read in conjunction with the accompanying drawings.

[0010] Figure 1 shows one example of a catheter management device according to aspects of the disclosure.

[0011] Figures 2A-2H show a catheter management device according to aspects of the disclosure at various states of installation according to aspects of the disclosure. [0012] Figures 3A-3D show a catheter management device according to aspects of the disclosure at various states of installation according to aspects of the disclosure.

[0013] Figure 4 shows an example of a catheter management device according to aspects of the disclosure.

[0014] Figure 5 shows an example of a catheter management device according to aspects of the disclosure.

[0015] Figure 6 shows an example of a catheter management device according to aspects of the disclosure.

[0016] Figure 7A shows an example of a catheter management device according to aspects of the disclosure installed on tubing of a catheter.

[0017] Figures 7B-7G show various alternative examples of a catheter management device according to aspects of the disclosure.

[0018] Figure 8A shows an example of a catheter management device according to aspects of the disclosure.

[0019] Figure 8B shows the catheter management device of Figure 8A installed on a catheter.

[0020] Figure 9 shows a catheter management device according to aspects of the disclosure.

DETAILED DESCRIPTION

[0021] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts can be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

I. Terminology

[0022] Reference throughout this specification to one aspect, an aspect, one example or an example means that a particular feature, structure or characteristic described in connection with the embodiment or example may be a feature included in at least example of the present disclosure. Thus, appearances of the phrases in one aspect, in an aspect, one example or an example in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures or characteristics may be combined in any suitable combinations and/or subcombinations in one or more embodiments or examples.

[0023] Throughout the disclosure, the terms substantially or approximately may be used as a modifier for a geometric relationship between elements or for the shape of an element or component. While the terms substantially or approximately are not limited to a specific variation and may cover any variation that is understood by one of ordinary skill in the art to be an acceptable level of variation, some examples are provided as follows. In one example, the term substantially or approximately may include a variation of less than 10% of the dimension of the object or component. In another example, the term substantially or approximately may include a variation of less than 5% of the object or component. If the term substantially or approximately is used to define the angular relationship of one element to another element, one non-limiting example of the term substantially or approximately may include a variation of 5 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits to one of skill in the relevant art.

[0024] For purposes of the disclosure, directional terms are expressed generally with relation to a standard frame of reference when the aspects or articles described herein are in an in-use orientation. In some examples, the directional terms are expressed generally with relation to a left-hand coordinate system.

[0025] Terms such as a, an, and the, are not intended to refer to only a singular entity, but also include the general class of which a specific example may be used for illustration. The terms a, an, and the, may be used interchangeably with the term at least one. The phrases at least one of and comprises at least one of followed by a list refers to any one of the items in the list and any combination of two or more items in the list. All numerical ranges are inclusive of their endpoints and non-integer values between the endpoints unless otherwise stated.

[0026] The terms first, second, third, and fourth, among other numeric values, may be used in this disclosure. It will be understood that, unless otherwise noted, those terms are used in their relative sense only. In particular, certain components may be present in interchangeable and/or identical multiples (e.g., pairs). For these components, the designation of first, second, third, and/or fourth may be applied to the components merely as a matter of convenience in the description.

[0027] The terms disposed on, disposed along, disposed with, or disposed toward and variations thereof may define one element can be integral with another element, or that one element can be a separate structure bonded to or placed with or placed near another element.

[0028] The term at, for example when referring to something being located at a specific location, is intended to include any one or more of: proximate, on, near, adjacent to or within the specific location. As used herein, the terms proximal is defined with respect to an object, element, or user. For example, the term proximal may refer to the part or portion closer to the user.

II. Overview

[0029] This overview, and the detailed description that follows, has been presented for purposes of illustration and description. It is not intended to be exhaustive nor to limit the disclosure to the forms described. Numerous modifications are possible considering the teachings herein, including any combination of the different examples described herein. Some of those modifications have been discussed and others will be understood by those skilled in the art. The various aspects were chosen and described to best illustrate the principles of the present disclosure and various aspects as are suited to the particular use contemplated. The scope of the present disclosure is, of course, not limited to the examples or aspects set forth herein but can be employed in any number of applications and equivalent devices by those of ordinary skill in the art. Rather, it is hereby intended the scope be defined by the claims appended hereto.

[0030] Typically, the dressing procedure of an indwelling catheter involves placement of several separate components (foam pad, gauze, self-adhesive dressing) and some users find it difficult to apply the dressing procedure components on their own. For example, to dress a catheter, a foam dressing may be placed around the catheter exit from the body, the catheter may be coiled into place, and a piece of gauze may be placed over the catheter, and then a sheet of self-adhesive dressing (e.g., 3M™ Tegaderm™) may be applied over the foam, catheter, and gauze. Many users find it difficult to accomplish this workflow without the assistance of a second person. [0031] Use and maintenance of an indwelling catheter and related drainage system requires a series of clean and/or aseptic steps for pre-drainage, bottle/bag drainage, and post-drainage procedures. These steps are in place to promote care and cleanliness of the catheter. The steps required for pre-drainage and post-drainage, especially dressing and/or securing of the exit point of an indwelling catheter can be difficult to manage with only two hands while maintaining cleanliness and/or aseptic protocol. The difficulty in managing a dressing procedure may increase the chance of user error, contamination, and/or may reduce a patient’s compliance for regular drainage via the catheter and/or replacement of the catheter and/or dressing. Additionally, it may be especially difficult for a patient to dress their catheter on their own if the catheter is in a hard-to-reach location such as on the side of the chest over the ribcage and/or if the patient experiences mobility challenges.

[0032] A dressing or catheter management system is disclosed in this disclosure. The dressing or catheter management system may significantly improve ease and efficiency of applying a catheter dressing, and may especially benefit a patient and/or caregiver applying the dressing or catheter management system independently., i.e., without the help of others. The aspects described herein provide a safety and/or efficiency advantage for catheter patients. In one example, the aspects described herein are usable with indwelling pleural catheter systems. In another example, the aspects described herein are usable with indwelling peritoneal catheter systems. It is noted that aspects described herein are applicable to all types of catheter systems, ports, and/or intravenous therapy systems as well.

[0033] In one example implementation, an all-in-one dressing may combine all the components needed to secure and dress a catheter into one, such that various folds can be made to create a "pocket" to slide over or otherwise confine the catheter therein and then cover the exit site.

[0034] The dressing or dressing pouch and a catheter management system and apparatuses described herein may further significantly improve ease of managing the portion of a catheter that extends from a patient by allowing a user to easily hold or otherwise store the catheter in a coiled or looped configuration to improve ease of use and user management of the catheter during dressing, pre-drainage, and/or post-drainage, especially dressing and/or securing of the entrance/exit point the indwelling catheter with only two hands while maintaining cleanliness and/or aseptic protocol. The aspects described herein may further improve safety and/or comfort of a catheter when the catheter is stored and held against a patient’s body between drainage procedures. [0035] Some advantages of the disclosed dressing or catheter management system include but are not limited to: less components to simplify the dressing process and cost; easier and more intuitive steps to reduce the complexity of exit site maintenance; and/or the ability for all dressing components to be held on the skin during the procedure to make it more convenient to apply the dressing independently, e.g., so that the patient can place the dressing over the catheter without needing assistance from a caregiver.

[0036] Additional details and examples and advantages are described in the non-limiting examples below.

III. Detailed Examples

[0037] In one aspect of the disclosure a system and apparatus for dressing or otherwise managing a catheter is disclosed. In some examples, the system and apparatus may be used to dress or otherwise manage a proximal portion (i.e., the portion of the catheter outside of a patient’s body). Figure 1 shows an example of the external portion 70 of a catheter outside of a patient’s body to the patient’s skin 50. In the example shown in Figure 1, a dressing 100 is shown that both covers and isolates the patient’s skin from contact with the catheter and includes a portion for covering or sealing-off the external portion 70 of the catheter from an external environment. Further, a gauze or other non-stick material 71 (e.g., as a separate piece of material or built-into or pre-adhered to the dressing may be used to prevent the catheter from sticking to the dressing.

[0038] Figures 2A - 2H show examples of a catheter management system or dressing according to aspects of the disclosure. It is noted that throughout the disclosure the terms catheter management system and catheter dressing or dressing may be used interchangeably. Turning to Figure 2A-2B, a top uninstalled view (Figure 2A) and a bottom uninstalled view (Figure 2B) of a catheter management system according to aspects of the disclosure are shown. The catheter management system 200 may include a first catheter management portion 202 that includes a bottom or first surface (i.e., the surface shown in Figure 2B that contacts a patient’s skin) and a top surface or second surface (i.e., the surface shown in Figure 2A and that faces away from the patient’s skin).

[0039] The first catheter management portion 202 may further include a catheter pass through portion for passing a catheter from the first surface of the first catheter management portion 202 to the second surface of the first catheter management portion 202. In one example, the catheter pass-through portion 212 may be slit or other opening that extends from the first surface to the second surface. Further, the catheter pass-through portion 212 may pass from a substantially central portion of the first catheter management portion 202 to a first a first edge as shown in Figures 2A and 2B. The first catheter management portion 202 may further include a widened opening 222 that has a larger dimension than the catheter pass- through portion 212 to captively contain a portion of a catheter once the first catheter management portion 202 is installed over the catheter. As shown in Figures 2A and 2B, the widened opening 222 may further be located close to, near, proximal to, or at a center of the first catheter management portion 202.

[0040] In one example, the first or bottom surface of the first catheter management portion 202 may include an adhesive 213 or may include sections of adhesive. The adhesive may be used to adhere the first catheter management portion 202 to a patient’s skin once the catheter has been passed though the catheter pass-through portion 212 and/or widened opening 222 and the catheter management system 200 is suitably placed. As noted below and discussed in further detail with respect to Figures 3 A-3D, the adhesive and/or the first surface of the first catheter management portion 202 may include an adhesive stand-off portion to keep the first surface spaced from a patient’s skin (even with the adhesive exposed) to prevent accidental adherence of the adhesive to an unintended portion of a patient’s skin. The adhesive portion may further include a release liner that protects the adhesive until a user is prepared to install the catheter management system 200 to a patient skin. The release liner may have a pull tab, split-seam, or other features that allow a user to easily remove the release liner from the adhesive.

[0041] As shown in Figures 2A and 2B, the catheter management system 200 may further include a fold over portion 204. It is noted that throughout the disclosure, the terms fold over and cover may be used interchangeably. The fold over portion may be integrally constructed with or formed of the same material as the first catheter management portion 202. In some examples a pre-bent or stressed seam may exist between the first catheter management portion 202 and the fold over portion 204 to guide folding over of the fold over portion 204 onto the first catheter management portion 202. In another example, the fold over portion 204 may be formed of a different material from the first catheter management portion 202 and/or may be formed of the same material and adhered or fused to the first catheter management portion 202. As described in further detail below, the fold over portion 204 is configured to fold over the first catheter management portion 202 (and the catheter protruding through widened opening 222) to hold the catheter in place or otherwise protect the catheter during a dressing operation and/or after use of the catheter and/or in preparation for use of the catheter. In one example implementation the fold over portion 204 may include one or more adhesive portions 214 and 224. The one or more adhesive portions may include an adhesive that allows the fold over portion 204 to be adhered to one or more edges of the first catheter management portion 202 to form a pouch to hold a catheter therein. The one or more adhesive portions 214 and 224 may come pre-connected to the fold over portion 204 and may include a release liner with a tab or split portion to allow a user to easily remove the release liner to expose the adhesive of the one or more adhesive portions 214 and 224.

[0042] The catheter management system 200 may further include second fold over portion 206. The fold over portion may be integrally constructed with or formed of the same material as the first catheter management portion 202 and/or the fold over portion 204. In some examples a pre-bent or stressed seam may exist between the first catheter management portion 202 and the second fold over portion 206 to guide folding over of the second fold over portion 206 to cover the fold over portion 204 and/or the first catheter management portion 202. In another example, the second fold over portion 206 be formed of a different material from either one of or both of the catheter management portion 202 and/or the fold over portion 204 and/or may be formed of the same material and adhered or fused either one of or both the first catheter management portion 202 and the fold over portion 204. As described in further detail below, the second fold over portion 206 is configured to fold onto and cover the fold over portion 204 and the first catheter management portion 202 (and the catheter protruding through widened opening 222) to hold the catheter in place or otherwise seal -off or protect the external portion of the catheter after installation or adjustment of the catheter and/or use of the catheter and/or in preparation for use of the catheter. In one example implementation the second fold over portion 206 may include one or more adhesive portions 216. In one example, the one or more adhesive portions 216 may surround the outer border of the second fold over portion 206. The one or more adhesive portions may include an adhesive that allows the second fold over portion 206 to be adhered to one or more edges of the fold over portion 204 and/or the first catheter management portion 202 to contain a catheter therein. In another example, the entire surface of the second fold over portion 206 may have an adhesive thereon or may be formed of an adhesive backed material, so that the second fold over portion is configured to adhere to the first fold over portion 204 and a patient’s skin when folded over. The one or more adhesive portions 216 may come pre-connected to the second fold over portion 206 and may include a release liner with a tab or split portion to allow a user to easily remove the release liner to expose the adhesive of the one or more adhesive portions 216.

[0043] The second fold over portion 206 may further include tab portion 226. The tab portion may extend from an edge of the second fold over portion 206 and may improve a user’s ability to fold over or otherwise secure or adhere the second fold over portion 206 or to remove the second fold over portion 206 from a patient’s skin when needing to access the catheter and/or when replacing the catheter management system 200.

[0044] Figures 2C-2H show one example of a method of installing a catheter management system 200 according to aspects of the disclosure. As shown in Figures 2C and 2D, a user may first peel off the release liner of the adhesive on a first side of the first catheter management portion 202 (shown in Figure 2B) and may feed the catheter (e.g., catheter indicated by line 270) through catheter pass-through portion 212 to the widened opening 222. The user may then adhere the aforementioned adhesive to patient’s skin via light pressure to ensure the first surface of first catheter management portion 202 is adhered to the patient’s skin. The release liner of the one or more adhesive portions 214 and 224 may then be removed and the fold over portion 204 may be folded over the fold line FF (which as noted above may be pre-folded, perforated, or otherwise configured to fold along the line FF) in the direction indicated by the arrow in Figures 2C and 2D and the one or more adhesive portions 214 and 224 adhered to the second surface of the first catheter management portion 202 to form a pouch around the catheter 270. Once the pouch is formed the one or more adhesive portions 216 of the second fold over portion 206 may be removed and the second fold over portion 206 may be folded over fold line SS in the direction indicated by the arrow shown in Figures 2F and 2G over the catheter 270, the first catheter management portion 202 and the fold over portion 204 and adhered to a patient’s skin to sealingly contain the external portion of the catheter 270.

[0045] When a drainage operation is necessary, or when catheter access is needed, the second fold over portion 206 may be removed with the assistance of tab portion 226 and the catheter 270 can be accessed via the opening in the pouch formed by the non-adhesive edge of the fold over portion 204 and the first catheter management portion 202.

[0046] In one example, all adhesive liners mentioned above could be labeled clearly with numbers and/or color coded and/or may include any combination of written and/or pictographic instructions thereon so that the user can comprehend the steps clearly. [0047] In some examples, the aforementioned and/or a related procedure and/or method for applying the catheter management system may be described in instructions provided with the catheter management system 200 and any additional components included therewith (e.g., a catheter, drainage bag or bottle and/or other catheter components). The instructions may be provided as a pamphlet or as written instructions on the packaging of the catheter management system 200 or kit including the catheter management system 200. The aforementioned instructions may also be provided as digital content (provided by accessing information on a network, such as a webpage on the Internet). In one example, the catheter management system dressing, packaging of the catheter management system 200 and/or any components provided therewith may include an address and/or a quick response “QR” code for accessing instructions and/or digital content related to methods of use thereof. In addition, the instructions may also be provided by salesperson via marketing materials to name another non-limiting example.

[0048] In one example, any portion of or the catheter management system 200 could be formed of an absorbing material (such as gauze).. In the example above, the second fold over portion 206 may be formed of or partially formed of semi-permeable polyurethane film self- adhesive dressing (e.g., 3M™ Tegaderm™). In another example, the fold over portion 206 may be formed of a hydrocolloid dressing, flexible fabric (cotton-rayon blend) or foam sheet. In another example, any one of the aforementioned portions of the catheter management system 200 may be formed of a laminate of foam and gauze to provide cushioning and/or padding while maintaining low friction with the catheter.

[0049] In an example that may be implemented either in combination with or as an alternative to the aforementioned absorbing material, the absorbing material and/or self- adhesive dressing may be substituted with or may include an electrogel and/or a silver containing material or other material with anti-bacterial qualities.

[0050] Figures 3A-3D show another example of a catheter management system 300 according to aspects of the disclosure. The catheter management system 300 may share features with or may be analogous with the catheter management system 200 described above.

[0051] Turning to Figures 3A and 3B, which show a first side (i.e., a front view) of an uninstalled catheter management system 300 and a second side (i.e., rear view) of an uninstalled catheter management system, respectfully, the catheter management system 300 may include a first catheter management portion 360 with a catheter pass through portion for passing a catheter from the first surface 362 (that is configured to face or contact a patient’s skin) of the first catheter management portion 360 to the second surface 363 (that is configured to face-away from a patient’s skin) of the first catheter management portion 360.

[0052] In one example, the catheter pass-through portion 367 may be slit or other opening that extends from the first surface to the second surface. Further, the catheter pass-through portion 367 may extend from a substantially central portion of the first catheter management portion 360 to a first a first edge as shown in Figures 3A-3C. The first catheter management portion 360 may further include a widened (e.g., similar to the opening 222 described above with respect to Figures 2A and 2B) that has a larger dimension than the catheter pass-through portion 367 to captively contain a portion of a catheter once the first catheter management portion 360 is installed over the catheter. As shown in the example of Figures 2A and 2B, the widened opening 222 may further be located close to, near, proximal to, or at a center of the first catheter management portion 360.

[0053] In one example, the first or bottom surface (e.g., the skin-facing side that is indicated by the arrow in Figure 3C) of the first catheter management portion 360 may include an adhesive or may include sections of adhesive 363. The adhesive may be used to adhere the first catheter management portion 360 to a patient’s skin once the catheter has been passed though the catheter pass-through portion 367 and the catheter management system 300 is suitably placed. As best shown in Figure 3C, the catheter management system 300 further includes a fold-over portion 302 connected to the first or bottom surface 362 of the first catheter management portion 360. The fold-over portion 302 may include an adhesive portion 322 near or adjacent to the connection between the first surface 362 of the first catheter management portion 360 and the fold-over portion 302. The adhesive portion 322 may be configured to be used in conjunction with a stand-off feature 338. The stand-of feature may include two or more pre-creased sections 332a and/or 332b that are configured to maintain a spacing (i.e., spaced a width of the stand-off feature 338) from a patient’s skin to keep the fist surface 362 of the first catheter management portion 360 spaced from a patient’s skin (even with the release liner of the adhesive portion 322 removed and the adhesive exposed) to prevent accidental adherence of the adhesive 322 to an unintended portion of a patient’s skin. Once the catheter management system 300 is properly placed, a user may then press down on the first catheter management portion 360 to adhere the first catheter management portion 360 and fold-over portion 322 to a patient’s skin. [0054] After the catheter management system 300 is adhered to a patient’s skin, the fold- over portion 302 may be folded over a crease line 365 and an adhesive portion 313 may be adhered to a patient’s skin covering the first catheter management portion 360 and the catheter 370 as shown in Figure 3D. Once the fold-over portion 302 is adhered to a patient’s skin 50, the catheter 370 may be fully contained within the catheter management system 300 and protected from the external environment. When access to the catheter 370 is needed, the fold- over portion 302 may be removed in a similar or identical fashion as described above with respect to Figures 2A-2H.

[0055] In the example shown in Figure 3A, the fold-over portion 302 may be comprised of a gauze or other absorbent center section 342 and an adhesive outer perimeter 313, which in some examples may not be absorbent. In some examples, the fold-over portion 302 may be an adhesive sheet with the absorbent center section 342 pre-adhered or otherwise connected to the adhesive sheet. As noted above, the adhesive portion 313 may be covered with a release liner or other removable protective member. In one example, the first catheter management portion 360 in the aspects described above may be formed of a foam or other padded material and the fold-over portion 302 may be formed of an semi-permeable self-adhesive dressing (e.g., 3M™ Tegaderm™), with a gauze or other absorbent and/or padded material pre-adhered or otherwise connected to the center portion 342 to provide padding for the catheter and prevent the fold-over portion 302 from adhering to the catheter during installation or after the catheter management system 300 is installed. In another example, the fold-over portion 302 may be formed of a hydrocolloid dressing, flexible fabric (cotton-rayon blend) or foam sheet with an adhesive backing on one side and a with a gauze or other absorbent and/or padded material pre-adhered or otherwise connected to the center portion 342.

[0056] While not shown in the example of Figures 3A-3D, the fold-over portion 302 may further include tab portion (e.g., similar to the tab portion 226 described above with respect to Figures 2A-2H). The tab portion may extend from an edge of the fold-over portion 302 and may improve a user’s ability to fold over or otherwise secure or adhere the fold-over portion 302 or to remove the fold-over portion 302 from a patient’s skin when access to the catheter 370 is required.

[0057] In another example, any one of the aforementioned portions of the catheter management system 300 may be formed of a laminate of foam and gauze to provide cushioning and/or padding while maintaining low friction with the catheter. [0058] In one example, all adhesive liners mentioned above could be labeled clearly with numbers and/or color coded and/or may include any combination of written and/or pictographic instructions thereon so that the user can comprehend the steps clearly.

[0059] In some examples, the aforementioned and/or a related procedure and/or method for applying the catheter management system 300 can be described in instructions provided with the catheter management system 300 and any additional components included therewith (e.g., a catheter, drainage bag or bottle and/or other catheter components). The instructions may be provided as a pamphlet or as written instructions on the packaging of the catheter management system 300 or kit including the catheter management system 300 The aforementioned instructions may also be provided as digital content (provided by accessing information on a network, such as awebpage on the Internet). In one example, the catheter management system, packaging of the catheter management system 300 and/or any components provided therewith may include an address and/or a quick response “QR” code for accessing instructions and/or digital content related to methods of use thereof. In addition, the instructions may also be provided by salesperson via marketing materials to name another non-limiting example.

[0060] In an example that may be implemented either in combination with or as an alternative to the aforementioned absorbing material, the absorbing material and/or self- adhesive dressing may be substituted with or may include an electrogel and/or a silver containing material or other material with anti-bacterial qualities.

[0061] In one alternative example, the first catheter management portion 360 may extend and include a crease or other feature to guide folding. The extended portion 362b may function as an additional fold-over portion 362b that is configured to be folded over the catheter 370 and a first portion 362a of the first catheter management portion 360 before the fold-over portion 302 is adhered to a patient’s skin. The extended portion 362b may provide additional padding and protection to the catheter 370 contained within the catheter management system 300. Further, it is noted that while the catheter management system 300 can be a square as shown, the shape of the dressing is not intended to be limiting and may be another shape such as round, oval, and/or rectangular to name a few examples.

[0062] While the aspects described above include all-in-one systems or systems that have a final adhesive sheet configured to cover the catheter implemented therein, in some examples, a pouch or pouch like system may be desired, where the pouch is separate from or may be used with an adhesive backed sheet. For example, a pouch or pouch-like system may be installed around the catheter and/or adhered to the patient. Once the pouch-like system is installed, an adhesive backed sheet may be adhered to the pouch or pouch-like system and a patient’s skin surrounding the pouch or pouch like system to seal off the pouch or pouch-like system and catheter contained therein from an external environment. In some examples, the pouch or pouch like system may be used without the adhesive backed sheet described above and may instead be used alone to help manage the catheter (i.e., provide support for the catheter without requiring a user to hold the catheter).

[0063] Figure 4 shows one example of a catheter management system as a pouch 400 according to aspects of the disclosure. The pouch 400 may include any one of the features described above with respect to the catheter management system 200 and/or the catheter management system 300 and may be analogous with the catheter management system 200 and/or the catheter management system 300 described above. The pouch may be formed of a foam and include a slit 463 configured to have a catheter installed therethrough so that the catheter can be contained within the opening 470 of the pouch. The pouch may include a first edge 402, a second edge 404 and/or a third edge 405 and may be formed of two pieces of foam (e.g., a first piece 401 and a second piece 403) that may be connected at two or more of the aforementioned edges. The first piece of foam 401 may include an adhesive on a skin-facing side of the patient to allow the pouch 400 to be adhered to a patient’s skin. In one example, the pouch 400 may be formed of a single piece of foam that is folded-over then connected or otherwise fastened or adhered to at least a first edge (e.g., any one of edges 402, 404, and/or 405).

[0064] Figure 5 shows another example of a catheter management system as a pouch 500 according to aspects of the disclosure. The pouch 500 may include any one of the features described above with respect to the catheter management system 200 and/or the catheter management system 300 and may be analogous with the catheter management system 200 and/or the catheter management system 300 described above. The pouch 500 may be formed of a gauze or other absorbent material and include a slit 563 configured to have a catheter 570 installed therethrough so that the catheter can be contained within the opening 571 of the pouch. The pouch 500 may include a first edge 502, a second edge 504 and/or a third edge (hidden from view but similar to edge 405 in Figure 4) and may be formed of two pieces of gauze or other absorbent material (e.g., a first piece 501 and a second piece 503) that may be connected at two or more of the aforementioned edges. The first piece of gauze or absorbent material 501 may include an adhesive on a skin-facing side of the patient to allow the pouch 500 to be adhered to a patient’s skin. In one example, the pouch 500 may be formed of a single piece of gauze or other absorbent material that is folded-over then connected or otherwise fastened or adhered to at least a first edge (e.g., any one of edges 402, 404, and/or 405).

[0065] Figure 6 shows another example of a catheter management system as a pouch 600 according to aspects of the disclosure. The pouch 600 may include any one of the features described above with respect to the catheter management system 200 and/or the catheter management system 300 and may be analogous with the catheter management system 200 and/or the catheter management system 300 described above. The pouch 500 may be formed of a foam or other padded material and/or a gauze or other absorbent material, and include a slit 667 configured to have a catheter installed therethrough so that the catheter can be contained within the opening 670 of the pouch. The pouch 600 may include first edges 602a and 602b, a second edge 604 and/or a third edge 605 and may be formed of two pieces of gauze or other absorbent material (e.g., a first piece 601 and a second piece 603) that may be connected at two or more of the aforementioned edges. The first piece of foam 601 may include an adhesive on a skin-facing side of the patient to allow the pouch 600 to be adhered to a patient’s skin. In one example, the pouch 600 may be formed of a single piece of gauze or other absorbent material that is folded-over then connected or otherwise fastened or adhered to at least a first edge (e.g., any one of edges 604, and/or 605). The pouch 600 of Figure 6 includes two sides that are open, which in some cases may be advantageous if regular access to the catheter is needed.

[0066] It is noted that while the pouches described above are described with a specific material, any combination of materials may be used. For example, any one of the aforementioned pouches can be formed of a combination of a foam or other padded material and/or gauze or other absorbent material. In an example that may be implemented either in combination with or as an alternative to the aforementioned foam and/or gauze, the foam and/or gauze may be substituted with or may include an electrogel and/or a silver containing material or other material with anti-bacterial qualities. In another example, any one of the aforementioned portions of the pouches 400, 500 and/or 600 may be formed of a laminate of foam and gauze to provide cushioning and/or padding while maintaining low friction with the catheter.

[0067] Further, it is noted that while the pouches described above can be a square as shown, the shape of the pouches is not intended to be limiting and may be another shape such as round, oval, and/or rectangular to name a few examples. [0068] The disclosed catheter management apparatus may further be or include a catheter holder mechanism with one or more openings that are dimensioned to hold or otherwise removably contain two or more sections of catheter tubing to one another. Figures 7A-7G show examples of catheter holder mechanisms that may improve the ability for a user to manage a catheter. To serve as an example for context, Figure 7A shows an example of a catheter management system or catheter holder mechanism 770 (it is noted that the terms catheter management system and catheter holder mechanism may be used interchangeably throughout this disclosure). Figure 7A shows a catheter holder mechanism 770 installed to the tubing of a catheter 700. The catheter holder mechanism 770 may include a first catheter containment portion 770a configured to captively hold or otherwise removably contain a first portion of a catheter and a second catheter containment portion 770b configured to captively hold or otherwise removably contain a second portion of the catheter. The first catheter containment portion 770a and/or the second catheter containment portion 770b of the catheter holder mechanism 770 catheter management may have openings sized to receive a section of catheter tubing and may be configured to removably contain two or more sections of the catheter tubing with respect to one another. The openings may be configured to have an interference or limited-slip fit (e.g., an inner diameter that is smaller than, slightly smaller than, or even equal to the outer diameter of the catheter tubing). The catheter holder mechanism 770 may significantly improve ease of managing the portion of a catheter 700 that extends from a patient. As shown in Figure 7A, the catheter management apparatus 770 may allow a user to easily hold or otherwise store the catheter 700 in a coiled or looped configuration, which may be helpful for further dressing the catheter and/or for storing the catheter (e.g., using any of the catheter management features described herein) against a patient’s body between drainage procedures. Holding two or more portions of the catheter tubing together with the catheter holder mechanism 770 may improve ease of use and user management of the catheter during dressing, pre-drainage, and and/or post-drainage, especially dressing and/or securing of the entrance/exit point the indwelling catheter with only two hands while maintaining cleanliness and/or aseptic protocol. Figures 7B-7C show various examples of catheter holder mechanisms 700a, 700b, 700c, and 700d within the scope of this disclosure with openings 722a-722d and 723a-723d for removably containing a portion of catheter tubing.

[0069] Figures 7F and 7G show examples of catheter holder mechanism 700e and 700f that may share features with or may be analogous with any of the catheter holder mechanism described, e.g., may include openings 72 le and/or 723f for allowing removable containment of a portion of a catheter above but a non-removable portion or slide-on portion 722e and/or 722f. Non-removably containing one of the two catheter containing portions on the catheter tubing may be beneficial to prevent the catheter management apparatus from falling off or otherwise unintentionally separating from the catheter tubing. The non-removable containment portion of the catheter management apparatus may be configured to loosely fit on the catheter tubing (e.g., have an inner diameter that is larger or slightly larger than the outer diameter of the catheter tubing) or may have an interference or limited-slip fit (e.g., an inner diameter that is smaller than, slightly smaller than, or even equal to the outer diameter of the catheter tubing).

[0070] In another variant of a catheter holding mechanism according to aspects of the disclosure, the catheter management apparatus may instead be configured to removably hold or otherwise contain a section of catheter tubing to a catheter cap. Figures 8A and 8B show an example of this variant but may share features with or be analogous with any one or combination of the catheter management features described herein. The catheter management system 800 may include a first containment portion 870a as a catheter cap 824 that may be configured to be removably engaged with the end of the catheter to seal-off and/or protect the opening of the catheter 771. The catheter cap 824 may have attached thereto or integrated therein a second containment portion as a catheter tubing containment portion 870b that may include any one or combination of the features described above with respect to Figures 7A- 7G. The catheter tubing containment portion 822, 870b may have an opening to removably receive a portion of a catheter tubing and the containment portion may have a round or curved inner surface configured to hold or otherwise contain a portion of catheter tubing with respect to the cap 824. The catheter management system 800 may further include a catheter connector engagement feature 825 that is configured to provide positive engagement with corresponding engagement feature of the port of the catheter 771. For example, the catheter connector engagement feature 825 may include a flexible ridge or protrusion 827 configured to engage with a concavity or groove of the catheter 771.

[0071] In another variant of a catheter holding mechanism according to aspects of the disclosure shown in Figure 9, the cap portion 924 may include a swivel mechanism that allows the catheter tubing containing portion to swivel with respect to the catheter cap 924. The swivel mechanism of the implementation described below may improve and simplify ease of storing (e.g., coiling) and/or preparation of the catheter for drainage. The swivel mechanism may further improve a user’s ability to store the catheter flat against a patient’s body when not in use.

[0072] Figure 9 is provided as an example of the aforementioned variant, but catheter management system 900 of Figure 9 may share features with or be analogous with any one or combination of the catheter management features described herein. The catheter management system 900 may include a first containment portion as a catheter cap 924 that may be configured to be removably engaged with the end of the catheter to seal-off and/or protect the opening of the catheter. The catheter cap 924 may have pivotally connected thereto a second containment portion as a catheter tubing containment portion 922 that may include any one or combination of the features described above with respect to Figures 7A-8G. The catheter tubing containment portion 922 may have an opening to removably receive a portion of a catheter tubing and the containment portion may have a round or curved inner surface configured to hold or otherwise contain a portion of catheter tubing with respect to the cap 924. The catheter tubing containment portion 922 may be pivotally connected to the catheter cap 924 via a pivot mechanism that includes a shaft 940 that has a rotatable collar 928 pivotally contained thereon. The catheter management system 900 may further include a catheter connector engagement feature 925 that is configured to provide positive engagement with corresponding engagement feature of the port of the catheter. For example, the catheter connector engagement feature 925 may include a flexible ridge or protrusion 926 configured to engage with a concavity or groove of the catheter.

[0073] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described herein that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

Claims

CLAIMS What is claimed is:

1. A catheter management system for containing a portion of a catheter that exits a patient’s body, the catheter management system comprising: a first catheter management portion comprising a first surface configured to contact a patient’s skin, a second surface opposite the first surface, the second surface configured to face away from a patient’s skin when the first surface contacts the patient’s skin and a catheter pass-through portion configured to have a proximal end of the catheter passed therethrough to isolate a portion of the proximal end of the catheter from a patient’s skin.

2. The catheter management system of claim 1, wherein the first catheter management portion further comprises a first edge, wherein the catheter pass-through portion comprises a slit that extends to the first edge of the first catheter management portion.

3. The catheter management system of any one of claims 1 or 2, wherein the catheter pass- through portion comprises an opening at inner region that extends from the first surface to the second surface.

4. The catheter management system of claim 2, wherein the catheter pass-through portion comprises an opening at an inner region of the catheter pass through portion that extends from the first surface to the second surface, wherein the slit extends from the opening to the first edge.

5. The catheter management system of any one of claims 1 to 4, wherein the first catheter management portion further comprises a first cover portion, wherein the first cover portion is configured to cover the catheter pass-through portion.

6. The catheter management system of claim 5, further comprising a second cover portion, wherein the second cover portion is configured to cover the first cover portion.

7. The catheter management system of any one of claims 5 or 6, wherein the first cover portion comprises a joining feature for joining the first cover portion to the second surface of the first catheter management portion.

8. The catheter management system of any one of claims 6 or 7, wherein the second cover portion comprises a joining feature for joining the second cover portion to the first cover portion.

9. The catheter management system of any one of claims 6-8, wherein the first cover portion is configured to cover the portion of the proximal end of the catheter that extends through the catheter pass-through portion.

10. The catheter management system of any one of claims 1 to 4, further comprising a second catheter management portion connected to one of a second edge and a third edge of the first catheter management portion.

11. The catheter management system of claim 10, wherein the second catheter management portion is about the same size as the first catheter management portion and the first catheter management portion and the second catheter management portion form a pocket for containing the portion of the proximal end of the catheter.

12. The catheter management system of claim 10 or 11, wherein the first catheter management portion and the second catheter management portion are a unitary structure.

13. The catheter management system of any one of claims 1 to 12, wherein the first catheter management portion is formed of a foam.

14. The catheter management system of any one of claims 1 to 12, wherein the first catheter management portion is formed of multiple layers of gauze.

15. The catheter management system of any one of claims 1 to 14, further comprising a catheter holder mechanism, wherein the catheter holder mechanism is configured to removably contain a portion of catheter tubing.

16. The catheter management system of any one of claims 1 to 14, further comprising a catheter holder mechanism, wherein the catheter holder mechanism is configured to removably contain a first portion of a catheter tubing to hold a first portion of the catheter with respect to a second portion of the catheter.

17. The catheter management system of any one of claims 15 or 16, wherein the catheter holder mechanism has a catheter tubing containment portion with an opening for removably receiving catheter tubing.

18. The catheter management system of claim 17, wherein the catheter holder mechanism has one of a catheter cap that is configured to be removably connected to the proximal end of the catheter and a catheter attachment portion that is configured to surround a portion of the catheter tubing.

19. The catheter management system of claim 18, wherein the catheter holder mechanism has a swivel mechanism, wherein the catheter containment portion is connected to the swivel mechanism and configured to swivel with respect to the catheter attachment portion.

20. The catheter management system of any one of claims 1 to 12, wherein the catheter management portion is formed of a laminate of foam and gauze.

20. A method of installing the catheter management system of any one of claim 1 to 19 to a patient.