Bandage with an integrated fixation system for a catheter

Abstract

Provided herein is an integrated dressing for use with a catheter assembly, the integrated dressing comprising a base defining a perimeter and including a bottom surface configured to contact a patient's skin, a cover portion attached to the base and configured to cover a site of catheter insertion, and a stabilization clip attached to the base or the cover portion and configured to releasably couple to a catheter adapter.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application Serial No. 63 / 342,356, filed May 16, 2022, entitled "Dressings with an Integrated Fixation System for Catheters", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention Provided herein are devices and systems for use in vascular access, and in particular, stabilization devices and vascular access systems including such devices.

[0003] Description of the Related Art During placement, a peripheral intravenous catheter (PIVC) can become occluded with a thrombus or fibrin, preventing the ability to withdraw blood through the PIVC. A line draw device is intended to pass through the catheter and open a fluid path for blood aspiration. One problem with these devices is that the catheter successfully passes through an s - shaped profile as it enters the blood vessel. The catheter tube can be slightly kinked at the bend of the s - curve (Figure 2), preventing the blood aspiration device from passing through successfully.

[0004] When inserting a PIVC into a patient, the angle at which the catheter is inserted is typically about 30°, depending on many factors including the patient's vasculature, the depth of the blood vessel, and the skill of the operator. Once the catheter is successfully inserted into the blood vessel, the catheter adapter will be secured to the patient using adhesive tape or a bandage. When securing the catheter adapter, the bandage is placed over the catheter adapter and the surrounding skin such that the catheter adapter is substantially parallel to the skin. Since the catheter is inserted at a steeper angle relative to the skin, the tube exiting the catheter adapter must transition downward from the plane of the adapter into the blood vessel, which may cause the tube to kink or deform such that a line draw device cannot pass through.

[0005] Proper fixation of a PIVC is an important step to ensure the success of a line draw device. Accordingly, there is a need in the art for a stabilization and immobilization device and bandage system that provides improved overall blood draw success, forward reliability of a line draw device, and reduced risk of catheter complications resulting from additional access and use of a PIVC for blood collection. SUMMARY OF THE INVENTION

[0006] Provided herein is an integrated bandage for use with a catheter assembly, the integrated bandage including a base defining a perimeter and having a bottom surface configured to contact a patient's skin, a cover portion attached to the base and configured to cover a site of catheter insertion, and a stabilization clip attached to the base or the cover portion and configured to releasably couple to a catheter adapter.

[0007] Also provided herein is a catheter assembly including a distal end portion, a proximal end portion, a lumen disposed between the distal end portion and the proximal end portion and in fluid communication between the distal end portion and the proximal end portion, and a catheter disposed at the distal end portion of the catheter adapter and in fluid communication with the lumen, and an integrated dressing including a base defining a perimeter and having a bottom surface configured to contact the patient's skin, a cover portion attached to the base and configured to cover the site of catheter insertion, and a stabilization clip attached to the base or the cover portion and configured to releasably connect to the catheter adapter. A stabilized catheter set is provided that includes the foregoing.

[0008] Also provided herein are steps of providing a catheter assembly including a distal end portion, a proximal end portion, a lumen disposed between the distal end portion and the proximal end portion and in fluid communication between the distal end portion and the proximal end portion, and a catheter disposed at the distal end portion of the catheter adapter and in fluid communication with the lumen; inserting the catheter into a patient; providing an integrated dressing including a base defining a perimeter and having a bottom surface configured to contact the patient's skin, a cover portion attached to the base and configured to cover the site of catheter insertion, and a stabilization clip attached to the base or the cover portion and configured to releasably connect to the catheter adapter; connecting the stabilization clip to the catheter adapter; and securing the base to the patient's skin. A method of securing a catheter at the site of insertion is provided that includes the foregoing steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0009]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

[0010] Description of the Invention The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the invention.

[0011] In 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 is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. Also, it is to be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0012] It is to be understood that the numerical ranges described herein are intended to include all values and sub-ranges subsumed therein. For example, the range "1 to 10" is intended to include all sub-ranges having a minimum value of 1 (the minimum value recited) to 10 (the maximum value recited), i.e., all sub-ranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0013] Provided herein is a stabilization device for a catheter assembly. The stabilization device described herein may be used to provide a secure site for attachment of a catheter adapter to a vascular access site, provide an optimal angle for entry of a catheter into a patient's vasculature, and reduce or eliminate kinking of medical devices passed through the catheter to the patient.

[0014] Referring now to FIG. 1, shown is a non-limiting embodiment of a catheter assembly 10 useful with the stabilization device described herein. The assembly 10 may include a catheter adapter 12, which may include a distal end portion 14 and a proximal end portion 16. In some embodiments, the catheter adapter 12 may include an additional port 18. In some embodiments, the port 18 may be disposed between the distal end portion 14 and the proximal end portion 16. In some embodiments, the port 18 may be disposed in the proximal end portion 16. In some embodiments, the first catheter adapter 12 may include a first lumen 20 extending through the distal end portion 14 and the proximal end portion 16. The first lumen 20 may be sealed at the proximal end portion 16 of the catheter adapter 12.

[0015] 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 vascular 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 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 connected to the port 18 at its distal end 26. In some non-limiting embodiments or aspects, a connector 30 may be connected 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, 60, or 75 degrees to the longitudinal axis of the connector 30), or any other type of connector known in the current art, and may include therein a second lumen having any number of branches suitable for the type of connector.

[0016] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set that includes a second fluid conduit, such as second fluid conduit 34 (which may be integrated with or removably connectable to catheter adapter 12, connector 30, and / or needleless access connector 32). Extension sets 34 are known to those of skill in the art and are commercially available, for example, under the NEUTRACLEAR trade name from Becton, Dickinson and Company. 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 of skill in the art. In a non-limiting embodiment, the second lumen (e.g., within 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.

[0017] The catheter assembly 10 may include a needleless access connector 32 and / or a second fluid conduit 34. Needleless access connectors 32 are known to those of skill in the art and are commercially available, for example, under the MAXPLUS, MAXZERO, Q-SYTE, and SMARTSITE trade names from Becton, Dickinson and Company.

[0018] Turning to FIG. 3, shown is a non - limiting embodiment of an integrated dressing 100 that includes a base 110 and a cover portion 120. The base 110 may be formed of any suitable material known to those skilled in the art that includes fabric. The base 110 may define a perimeter of any suitable shape. In non - limiting embodiments, 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 integrated dressing 100 is applied. In non - limiting embodiments, 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. In some non - limiting embodiments, the portion of the base 110 that includes the adhesive is covered by a removable tab 112. 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).

[0019] Continuing to refer to FIG. 3 and referring to FIG. 4, the integrated dressing 100 also includes a cover portion 120 coupled to the base 110. The cover portion may be coupled to the base 110 at one or more locations along the perimeter defined by the base 110, or substantially continuously along the perimeter. In some non - limiting embodiments, as shown in FIG. 4, the cover portion 120 includes an opening 145 through which at least a portion of a catheter assembly, such as the catheter assembly 10 shown in FIG. 1, can pass. In some non - limiting embodiments, the opening 145 is configured such that a first fluid conduit can pass therethrough. The cover portion 120 may be a single portion as shown in FIG. 3, or may be divided into multiple portions 120, 140 as shown in FIG. 4, for example. In some non - limiting embodiments, the cover portions 120, 140 are substantially or completely transparent, allowing visualization of the catheter assembly 10 disposed thereunder.

[0020] The one-piece bandage may further include a stabilization clip 130, which may be configured to connect, optionally reversibly, to one or more portions of a catheter adapter, such as catheter adapter 12. In some non-limiting embodiments, the stabilization clip 130 connects to the distal end 14 of the catheter adapter 12. In some non-limiting embodiments, the stabilization clip 130 connects to the catheter adapter 12 by snap fit, press fit, friction fit, or other connections known to those skilled in the art. In some non-limiting embodiments or aspects, the stabilization clip is formed of plastic, an elastomeric material, or other elastic material. In some non-limiting embodiments, the stabilization clip 130 is biased toward a position that secures one or more portions of the catheter adapter 12 thereto when connected thereto. For example, one or more portions of the stabilization clip 130 must be moved apart from each other to enable a portion of the catheter adapter 12 to be connected to the stabilization clip 130. In some non-limiting embodiments, the stabilization clip 130 is connected to the base 110 by, for example, one or more arms 115. The one or more arms 115 may be formed as part of the base 110 and / or may be formed of the same material as the base 110.

[0021] The stabilization clip 130 may be configured to hold the catheter adapter 12 at a fixed angle or within a fixed range of angles relative to the patient's skin. Thus, the stabilization clip may be angled relative to the base 110 such that the catheter adapter 12 is disposed at an angle of about 3 degrees to about 10 degrees (including all values and sub-ranges therebetween), optionally about 6 degrees to about 10 degrees, and optionally about 6 degrees relative to the skin of the patient to whom the one-piece bandage 100 is applied. The stabilization clip 130 may include one or more features for maintaining its optimal "s" curve while the catheter 12 (e.g., FIG. 2) is inserted into the patient, and may further optionally include one or more features to provide a downward bend to the catheter and / or to provide strain relief therefor.

[0022] Turning to FIGS. 5A-5B, shown is a non-limiting embodiment of a method of securing a catheter assembly to a patient using the integrated bandage 100 described herein. In some non-limiting embodiments, a catheter, such as catheter 22 as part of catheter assembly 10 shown in FIG. 1, is inserted into the patient's skin. A stabilization clip (not shown in FIGS. 5A-5B) is then coupled to catheter adapter 12 (FIG. 5A), for example by pressing the stabilization clip against catheter adapter 12. An integrated bandage may then be applied, for example by removing tab 112 that covers a portion of base 110 that includes an adhesive, to enable securing of integrated bandage 100 to the patient's skin (FIG. 5B). Use of the integrated bandage 100 described herein enables maintaining the catheter at an appropriate angle, facilitating insertion of various devices into the vasculature through the catheter, and maintaining sterility of the insertion site.

[0023] The present disclosure has been described in detail for purposes of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects. On the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any one embodiment may be combined with one or more features of any other embodiment.

Claims

1. An integrated dressing for use with a catheter assembly, comprising: a base defining a perimeter and including a bottom surface configured to contact a patient's skin; a cover portion attached to the base and configured to cover a site of catheter insertion; and a stabilization clip attached to the base or the cover portion and configured to releasably couple to a catheter adapter. The integrated dressing as claimed.

2. The integrated dressing as claimed in claim 1, wherein the base includes a fabric.

3. The integrated dressing as claimed in claim 2, wherein the fabric includes an adhesive on its bottom surface.

4. The integrated dressing as claimed in claim 1, further comprising a peelable tab disposed on the bottom surface of the base to cover the adhesive.

5. The integrated dressing as claimed in claim 1, wherein the base further includes one or more arms extending inwardly from the perimeter, and the stabilization clip is coupled to the one or more arms.

6. The integrated dressing as claimed in claim 1, wherein the stabilization clip is configured such that the catheter adapter is maintained at an angle with respect to the patient's skin.

7. The integrated dressing as claimed in claim 6, wherein the stabilization clip is configured such that the catheter adapter is maintained at an angle of about 3 degrees to about 10 degrees with respect to the patient's skin.

8. The integrated dressing as claimed in claim 1, wherein the cover portion includes an opening configured to allow at least a portion of the catheter assembly to pass therethrough.

9. A stabilized catheter set, comprising: a catheter assembly, a catheter adapter having a distal end, a proximal end, a lumen disposed therebetween and in fluid communication, and a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen; the catheter adapter as claimed; the catheter assembly as claimed; and an integrated dressing, comprising: a base defining a perimeter and including a bottom surface configured to contact a patient's skin; a cover portion attached to the base and configured to cover a site of catheter insertion; and a stabilization clip attached to the base or the cover portion and configured to releasably couple to the catheter adapter. An integrated bandage comprising A stabilization catheter set comprising

10. The stabilization catheter set according to claim 9, wherein the base comprises a fabric.

11. The stabilization catheter set according to claim 10, wherein the fabric is provided with an adhesive on its bottom surface.

12. The stabilization catheter set according to claim 9, further comprising a peelable tab disposed on the bottom surface of the base to cover the adhesive.

13. The stabilization catheter set according to claim 9, wherein the base further comprises one or more arms extending inwardly from the periphery, and the stabilization clip is connected to the one or more arms.

14. The stabilization catheter set according to claim 9, wherein the stabilization clip is configured such that the catheter adapter is maintained at an angle with respect to the skin of the patient.

15. The stabilization catheter set according to claim 14, wherein the stabilization clip is configured such that the catheter adapter is maintained at an angle of about 3 degrees to about 10 degrees with respect to the skin of the patient.

16. The stabilization catheter set according to claim 9, wherein the cover portion comprises an opening configured to allow at least a portion of the catheter assembly to pass therethrough.

17. A method of fixing a catheter at the insertion site, Providing a catheter assembly, A catheter adapter, A distal end portion, A proximal end portion, A lumen disposed between the distal end portion and the proximal end portion and in fluid communication, and A catheter disposed at the distal end portion of the catheter adapter and in fluid communication with the lumen, A catheter adapter comprising Providing a catheter assembly comprising Inserting the catheter into the patient, Providing an integrated bandage, A base defining a periphery, the base comprising a bottom surface configured to contact the skin of the patient, A cover portion attached to the base and configured to cover the catheter insertion site, and A stabilization clip attached to the base or the cover portion and configured to releasably connect to the catheter adapter, Providing an integrated bandage comprising Connecting the stabilization clip to the catheter adapter, and Fixing the base to the skin of the patient, A method comprising Claim 18 The one-piece bandage further comprises an adhesive on the bottom surface thereof and a peelable tab disposed on the bottom surface of the base covering the adhesive, and the method further includes removing the peelable tab from the bottom surface of the base before fixing the base to the skin of the patient. The method according to claim 17. Claim 19 The method according to claim 17, wherein the bottom surface of the base further comprises an antibacterial coating. Claim 20 The method according to claim 17, wherein the catheter adapter is maintained at an angle of about 3 degrees to about 10 degrees with respect to the skin of the patient during fixation.

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