A dressing optimized to facilitate drawing a line through an integral catheter with an angled extension

Abstract

Provided herein is a dressing for use with a catheter assembly that includes a base defining a perimeter and an interior, the base being configured to contact a patient's skin and including a bottom surface that includes a first opening in the perimeter, and a cover portion attached to the base and configured to cover a catheter insertion site, the cover portion including a second opening, the second opening being configured to align with the first opening of the base when the dressing is applied to the patient's skin.

Description

Technical Field

[0001] This specification provides devices and systems for use in vascular access, and in particular, dressings and vascular access systems including such dressings.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 342,343, filed May 16, 2022, entitled "Dressings Optimized to Facilitate Line Drawing Through an Integrated Catheter with Angled Extensions", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0003] Properly dressing a catheter is important for catheter dwell time and, among other things, minimizes the risk of patient discomfort, dislodgement, and phlebitis. Dressings can be designed for integrated catheters with 45-degree side ports. The angled slits in these dressings allow for application around the extension set while maintaining a seal that helps prevent microbial ingress. However, the slits often stick to the extension set during application, resulting in additional catheter manipulation before the dressing is properly secured. This increases the risk of dislodgement and skin irritation. In addition, existing dressings are intended to align the non-woven boundary with the wings of the adapter and the slit with the extension set. This alignment is not intuitive for many users and often leads to improper use.

[0004] Furthermore, in the case of many typical bandages, visibility is limited to the area around the insertion site. To monitor the health status of the patient's catheter insertion site, it is important to visualize the area around the adapter's extension set and nose. Visibility along the path of the line-drawing device enables tracking and troubleshooting in case of problems. Therefore, there is a need in the field for a bandage that enables improved visualization and fixation of an integrated catheter with an extension set. Summary of the Invention

[0005] Provided herein is a bandage for use with a catheter assembly including a base that defines a perimeter and an interior, the base being configured to contact the patient's skin and including a bottom surface that includes a first opening in the perimeter, and a cover portion attached to the base and configured to cover the catheter insertion site, the cover portion including a second opening, the second opening being configured to align with the first opening of the base when the bandage is applied to the patient's skin.

[0006] According to an embodiment of the present invention, the second opening is configured to form a seal around a portion of the catheter assembly passing through the first opening.

[0007] According to an embodiment of the present invention, the perimeter defines a shape that is not square, and the portion of the base that defines the first opening is arranged such that the portion forms an oblique angle.

[0008] According to one embodiment of the present invention, the base and / or the cover portion includes an adhesive on its bottom surface.

[0009] According to one embodiment of the present invention, the base and / or the cover portion further comprises a removable backing that at least partially covers the adhesive.

[0010] According to one embodiment of the present invention, the removable lining includes at least two sections, and the first opening and / or the second opening at least partially separates the at least two sections.

[0011] According to one embodiment of the present invention, the base includes a non-woven material. According to an embodiment of the present invention, the base defines an interior that substantially has the shape of a catheter adapter.

[0012] According to one embodiment of the present invention, the base and / or the cover portion further includes one or more alignment markers.

[0013] According to one embodiment of the present invention, the base includes two alignment markers disposed on opposite sides of the interior.

[0014] Also provided herein is a kit including at least one package including a catheter assembly including a catheter adapter including a distal end, a proximal end, a lumen disposed between the distal end and the proximal end and in fluid communication, a port disposed between the proximal end and the distal end at an angle to the lumen, a conduit in fluid communication with the port, and a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen. The kit further includes a dressing having a base defining a perimeter and an interior, the base being configured to contact a patient's skin, the base including a bottom surface including a first opening in the perimeter, and a cover portion attached to the base and configured to cover a catheter insertion site, the cover portion including a second opening configured to align with the first opening of the base when the dressing is applied to the patient's skin.

[0015] According to an embodiment of the present invention, the dressing is configured to form a seal around a portion of the catheter assembly passing through the first opening.

[0016] According to an embodiment of the present invention, the second opening of the dressing is configured to form a seal around the conduit of the catheter assembly.

[0017] According to one embodiment of the present invention, the perimeter of the dressing defines a shape that is not square, and the base portion that defines the first opening is arranged such that that portion forms an oblique angle.

[0018] According to one embodiment of the present invention, the base and / or cover portion of the dressing includes an adhesive on its bottom surface.

[0019] According to one embodiment of the present invention, the base and / or cover portion of the dressing further includes a removable backing that at least partially covers the adhesive.

[0020] According to one embodiment of the present invention, the removable backing includes at least two sections, and the first opening and / or the second opening at least partially separates the at least two sections.

[0021] According to one embodiment of the present invention, the base of the dressing includes a non-woven material.

[0022] According to one embodiment of the present invention, the base of the dressing defines an interior that substantially has the shape of a catheter adapter.

[0023] According to one embodiment of the present invention, the cover portion of the dressing further includes one or more alignment markers.

[0024] According to one embodiment of the present invention, the base includes two alignment markers disposed on opposite sides of the interior.

[0025] According to an embodiment of the present invention, the system includes a catheter assembly including a catheter adapter. The catheter adapter includes a distal end, a proximal end, a lumen disposed between the distal end and the proximal end and in fluid communication, a port disposed between the proximal end and the distal end at an angle to the lumen, a conduit in fluid communication with the port, and a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen. The system also includes a shroud for use with the catheter assembly including a base defining a perimeter and an interior, the base being configured to contact a patient's skin and including a bottom surface including a first opening in the perimeter, and a cover portion attached to the base and configured to cover the catheter insertion site, the cover portion including a second opening configured to align with the first opening of the base when the shroud is applied to the patient's skin.

[0026] According to an embodiment of the present invention, the second opening of the shroud is configured to form a seal around a portion of the catheter assembly passing through the first opening.

[0027] According to an embodiment of the present invention, the second opening of the shroud is configured to form a seal around the conduit of the catheter assembly.

[0028] According to an embodiment of the present invention, the perimeter of the shroud defines a shape that is not square, and the portion of the base defining the first opening is arranged such that the portion forms an oblique angle.

[0029] According to an embodiment of the present invention, the base and / or the cover portion of the shroud includes an adhesive on its bottom surface.

[0030] According to an embodiment of the present invention, the base and / or the cover portion of the shroud further includes a removable backing that at least partially covers the adhesive.

[0031] According to one embodiment of the present invention, the removable lining includes at least two sections, and the first opening and / or the second opening at least partially separate the at least two sections.

[0032] According to one embodiment of the present invention, the base of the dressing includes a non-woven material.

[0033] According to one embodiment of the present invention, the base of the dressing defines an interior that substantially has the shape of a catheter adapter.

[0034] According to one embodiment of the present invention, the base of the dressing and / or the cover portion further includes one or more alignment markers.

[0035] According to one embodiment of the present invention, the base includes two alignment markers disposed on opposite sides of the interior.

Brief Description of the Drawings

[0036]

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[0037] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0038] For purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and derivatives thereof shall relate to the invention as oriented in the drawings. However, it will be understood that the invention may assume various alternative variations, unless explicitly specified to the contrary. It will also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0039] It should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., ranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0040] Provided herein are dressings adapted for use with a catheter assembly, particularly a catheter assembly including an extension set, and kits and systems including such dressings. The dressings described herein can be used to provide a fixed attachment site of a catheter adapter to a venipuncture site and can provide improved visualization of such an extension set and / or a catheter adapter, an extension set, and a medical intervention delivered through such a catheter adapter.

[0041] Referring now to FIG. 1, a non-limiting embodiment of a catheter assembly 10 useful with a stabilization device is shown as described hereinafter herein. The catheter assembly 10 can include a catheter adapter 12 that can include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 can include an additional port 18. In some embodiments, the port 18 may be disposed between the distal end 14 and the proximal end 16. In some embodiments, the port 18 may be disposed at the proximal end 16. In some embodiments, the first catheter adapter 12 can include a first lumen 20 that extends through the distal end 14 and the proximal end 16.

[0042] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as is known to those skilled in the art. In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. The first fluid conduit 24 may be formed of any suitable material known to those skilled in the art, may have a distal end 26 and a proximal end 28, and the first fluid conduit 24 may be coupled to the port 18 at its distal end 26. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the proximal end 28 of the first fluid conduit 24. The connector 30 may be a T-connector (e.g., one side port disposed at an angle of 90 degrees to the longitudinal axis of the connector 30), a Y-connector (e.g., one side port disposed at an angle of 25 degrees, 60 degrees, or 75 degrees to the longitudinal axis of the connector 30), or any other type of connector known in the art, and may include a second lumen therethrough having any number of branches suitable for the type of connector.

[0043] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set that includes a second fluid conduit 34. In a non-limiting embodiment, the connector 30 includes a port 38 to which an extension set (e.g., the second fluid conduit 34) may be connected. The extension set 34 is known to those skilled in the art and is commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, NEUTRACLEAR, Q-SYTE, and SmartSite. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a luer connection 36 at its end. In some non-limiting embodiments or aspects, the extension set may include a clamp 40 to enable occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 may be formed of any suitable material known to those skilled in the art. In a non-limiting embodiment, the second lumen (e.g., within the connector 30) has an inner diameter that is substantially equal to the inner diameter of the first fluid conduit 24 and / or the second fluid conduit 34. The catheter assembly 10 may include a needleless access connector 32 and / or the second fluid conduit 34. The needleless access connector 32 is known to those skilled in the art and is commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, Q-SYTE, and SmartSite.

[0044] Referring to FIG. 2, a non-limiting embodiment of an optimized dressing 100 including a base 110 and a cover portion 120 is shown. The base 110 may be formed of any suitable material known to those skilled in the art, including woven fabric, optionally non-woven material. The base 110 may define a perimeter of any suitable shape. In a non-limiting embodiment, the base 110 defines a shape that is not a parallelogram. In a non-limiting embodiment, for example, as shown in FIGS. 2-6C, the base 110 has a perimeter that defines a notch region A that defines an angle B, optionally an obtuse angle, along at least one of its sides. In a non-limiting embodiment, the base 110 includes a top surface and a bottom surface, and the bottom surface is configured to contact the skin of a patient to whom the unitary dressing 100 is applied. In a non-limiting embodiment, the base 110 includes one or more suitable adhesives known to those skilled in the art on at least a portion of the bottom surface.

[0045] In a non-limiting embodiment, the base 110 includes a first opening 130 (optionally including only a single opening) configured to allow at least a portion of a catheter assembly, such as catheter assembly 10 (optionally the first fluid conduit 24), to pass therethrough. In a non-limiting embodiment, the first opening 130 is optionally disposed at the apex of an obtuse angle in a region defined by the angle B of the perimeter of the base 110, for example, as shown in the accompanying figures. In a non-limiting embodiment, for example, as shown in FIGS. 7A-8, the base 110 may define an internal alignment window 125 that is substantially the same shape as a catheter adapter, such as catheter adapter 12 shown in FIG. 1.

[0046] In some non-limiting embodiments, the portion of the base 110 that includes the adhesive is covered by a removable tab (e.g., backing). In non-limiting embodiments, the backing includes two portions that are optionally separate and distinct, and an opening, e.g., a first opening 130, defines the separation between the backings. In non-limiting embodiments, one or more adhesives may include one or more antimicrobial compositions. Suitable antimicrobial compositions are known to those skilled in the art and may include, for example, chlorhexidine gluconate (CHG).

[0047] Continuing to refer to FIG. 2, the cover portion 120 may be coupled to the base 110 at one or more locations along or substantially continuously along the perimeter defined by the base 110. In some non-limiting embodiments, the cover portion 120 is substantially or completely transparent to enable visualization of the catheter assembly 10 disposed thereunder. In non-limiting embodiments, the cover portion 120 includes an adhesive, optionally the same adhesive provided on the base 110, on its bottom surface to enable application and adhesion of the cover portion 120 to the base 110, the patient's skin, and / or one or more components of the catheter assembly 10. In non-limiting embodiments, the cover portion 120 comprises the base 110 as a single component pre-packaged as a single dressing. In non-limiting embodiments, the cover portion 120 includes a second opening 140 through which at least a portion of a catheter assembly, such as the catheter assembly 10 (optionally the first fluid conduit 24), may pass. The second opening 140 may be configured to form a seal around the portion of the catheter assembly 10 passing therethrough, thereby reducing the chance of infection at the catheter insertion site.

[0048] Referring to FIG. 3, in a non-limiting embodiment, the dressing 100 may include a secondary dressing or tape 150 as part of the packaging or as part of a kit with the catheter assembly 10. The secondary dressing or tape 150 may be a fabric, optionally a non-woven material, and may be the same material as the base 110. The secondary dressing or tape 150 may be applied under the components of the catheter assembly 10 passing through the first opening 130. The inclusion of the secondary dressing or tape 150 in combination with the opening 130 provides an improved seal around the portion of the catheter assembly 10 passing through the opening 130 and reduces the chance of infection. Additionally, including the secondary dressing or tape 150 provides mechanical stability, restricts movement of the catheter adapter 12 relative to the patient's skin, and reduces phlebitis and catheter dislodgment.

[0049] With reference to FIGS. 4 and 5, embodiments of the dressing 100 in use, applied to cover the catheter assembly 10, are shown. As can be appreciated, the arrangement of the base 110 and cover portion 120 of the dressing 100 allows for excellent visualization of the catheter adapter 12, the patient's skin around the catheter insertion site, and the first fluid conduit 24. As described above, the inclusion of the secondary dressing or tape 150 in combination with the opening 130 provides an improved seal 154 around the portion of the catheter assembly 10 passing through the opening 130 and reduces the chance of infection. As can be seen in the non-limiting embodiment of FIG. 5 (and FIG. 8), a tertiary dressing or tape 152 may be included to secure the second fluid conduit 34.

[0050] Turning to FIGS. 6A-6C, other non-limiting embodiments of the bandage 100 are shown. Specifically, the embodiments shown in FIGS. 6A-6C include different arrangements of the base 110 around the first opening 130. In FIG. 6A, the base 110 has a substantially uniform thickness C around its entire perimeter, including a notch region such as that shown as A in FIG. 2, around the first opening 130. In FIG. 6B, since the base 110 is not present in the notch region A, the first opening 130 is significantly larger than in FIG. 6A. In FIG. 6C, the base 110 has a greater thickness C along its perimeter in the region outside the notch region A.

[0051] With reference to FIGS. 7A-8, embodiments of the bandage 100 are shown where the base 110 defines an interior that is different from, for example, the open interior of the embodiments of FIGS. 6A-6C. In the embodiments of FIGS. 7A-8, the interior of the base 110 defines an opening 122 that may include an alignment window 125. Such an alignment window 125 can assist a medical professional in properly aligning the bandage 100 with respect to the catheter adapter 12. In non-limiting embodiments, the opening 122 is substantially U-shaped. In non-limiting embodiments, the alignment window 125 includes at least a portion that is made in substantially the same shape as a catheter adapter, such as the catheter adapter 12 shown in FIG. 1. As shown in FIGS. 7A-7D, the opening 122 and the alignment window 125 can be envisioned in several different configurations, including when a portion of the base 110 projects inwardly into the opening 122 to at least partially define the alignment window 125 (FIGS. 7B-7C), and when the alignment window 125 is completely separated from the opening 122 by a portion of the base 110 (FIG. 7D). In the illustrated embodiments of FIGS. 7A-8, the first opening 130 can be replaced by a slit 115 that can perform the same function (e.g., improving visibility by allowing components of the catheter assembly to pass therethrough).

[0052] In any non-limiting embodiment of the foregoing bandages, the alignment marker 160 may be disposed on the base 110 and / or the cover portion 120 of the bandage 100. In a non-limiting embodiment, such alignment markers function to provide a medical professional with an indication of any displacement of the bandage 100 and / or the catheter adapter 12 relative to the insertion site of the catheter 22. This can help the medical professional determine whether the bandage 100 and / or the catheter adapter 12 have caused unacceptable differences (e.g., whether they adequately prevent the risk of infection or pose problems of reduced use of the catheter 22 (e.g., kinking, dislodgement), which can limit the ability to introduce a medical device (e.g., a device for use in a line draw application) and / or a drug to the patient via the catheter 22 and / or limit the ability to draw blood through the catheter 22).

[0053] The present disclosure has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiments or aspects thereof, such detail being for that purpose only, and it is to be understood that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A dressing for use with a catheter assembly, comprising: a base defining a perimeter and an interior, said base including a bottom surface configured to contact a patient's skin, said perimeter including a first opening; and a base; a cover portion attached to said base and configured to cover a catheter insertion site, said cover portion including a second opening, said second opening being configured to align with said first opening within said base when said dressing is applied to the patient's skin; and a cover portion; A dressing comprising:

2. The dressing of claim 1, wherein said second opening is configured to form a seal around a portion of a catheter assembly passing through said first opening.

3. The dressing of claim 1, wherein said perimeter defines a shape that is not square, and the portion of said base that defines said first opening is arranged such that said portion forms an oblique angle.

4. The dressing of claim 1, wherein said base and / or said cover portion includes an adhesive on the bottom surface.

5. The dressing of claim 4, wherein said base and / or said cover portion further comprises a removable backing that at least partially covers said adhesive.

6. The dressing of claim 5, wherein said removable backing includes at least two sections, and said first opening and / or said second opening at least partially separates said at least two sections.

7. The dressing of claim 1, wherein said base includes a non-woven material.

8. The dressing of claim 1, wherein said base defines an interior that substantially has the shape of a catheter adapter.

9. The dressing of claim 1, wherein said base and / or said cover portion further comprises one or more alignment markers.

10. The dressing of claim 9, wherein said base includes two alignment markers disposed on opposite sides of said interior.

11. A catheter adapter, comprising: a distal end; a proximal end; a lumen disposed between said distal end and said proximal end and in fluid communication with said distal end and said proximal end; a port disposed between said proximal end and said distal end at an angle to said lumen; a conduit in fluid communication with said port; a catheter disposed at said distal end of said catheter adapter and in fluid communication with said lumen; A catheter adapter, and A dressing having a base that defines a perimeter and an interior, the base including a bottom surface configured to contact a patient's skin, the perimeter including a first opening, and the dressing; A cover portion attached to the base and configured to cover a catheter insertion site, the cover portion including a second opening, the second opening being configured to align with the first opening within the base when the dressing is applied to the patient's skin, and the cover portion; A catheter assembly comprising: A kit including at least one package.

12. The kit of claim 11, wherein the second opening of the dressing is configured to form a seal around a portion of the catheter assembly passing through the first opening.

13. The kit of claim 12, wherein the second opening of the dressing is configured to form a seal around the conduit of the catheter assembly.

14. The kit of claim 11, wherein the perimeter of the dressing defines a shape that is not square, and the portion of the base that defines the first opening is arranged such that the portion forms an oblique angle.

15. The kit of claim 11, wherein the base and / or the cover portion of the dressing includes an adhesive on the bottom surface.

16. The kit of claim 15, wherein the base and / or the cover portion of the dressing further comprises a removable backing that at least partially covers the adhesive.

17. The kit of claim 16, wherein the removable backing includes at least two sections, and the first opening and / or the second opening at least partially separates the at least two sections.

18. The kit of claim 11, wherein the base of the dressing includes a non-woven material.

19. The kit of claim 11, wherein the base of the dressing defines an interior that substantially has the shape of the catheter adapter.

20. The kit of claim 11, wherein the base and / or the cover portion of the dressing further comprises one or more alignment markers.

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