WO2021217257A1

WO2021217257A1 - Medical tubing securement device

Info

Publication number: WO2021217257A1
Application number: PCT/CA2021/050580
Authority: WO
Inventors: Colin NYULI; Case Bryant VAN WYNGAARDEN; Sanjiv Kumar BHALLA; Patrick Michael HANEY; Peter Andrew ZAKRZEWSKI; Randy Matthieu LANE; Mark Stephen SEGAL; Christopher Sandor POLLOCK
Original assignee: Kinetix Medical Technologies
Priority date: 2020-04-27
Filing date: 2021-04-27
Publication date: 2021-11-04

Abstract

A tubing securement device in accordance with the present invention includes an elongate flexible base. An elongate flexible anchor having an anchor top side, and an anchor bottom side opposite the top and adjacent to the second boss face, and a plurality of hinged sections adjacent to the boss, such that said second base side, said boss height, and said hinged sections define a space for securing tubing. Attached to the elongate flexible anchor are anchor securements, each having a multiple securement portions, and a tab, wherein the securement portions are configured to be releasably mated to each other. The anchor securements are configured to adopt an open configuration when not in mated contact, and a closed configuration when in mated contact, wherein said closed configuration covers said space for securing tubing and said open configuration reveals said space for securing tubing.

Description

MEDICAL TUBING SECUREMENT DEVICE

FIELD OF THE DISCLOSURE

[0001] The present disclosure relates generally to tubing securement devices, and more particularly to securement devices for securing medical tubing to a patient’s skin.

BACKGROUND OF THE DISCLOSURE

[0002] Medical treatment can involve long term catheterization of a patient, for administration of therapy or to help facilitate removal of fluids in the body. Examples include peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and urinary catheters. Long term indwelling catheters can be frustrating to manage for the patient, and improper management or inadvertent movement of the catheter can result in adverse medical events, catheter pullouts, or required re insertion of the catheter and any subsequent risks involved with re-insertion. In addition, when a catheter is inserted in a patient’s body conduit (such as a vein) and the catheter is moved relative to the conduit, the catheter can scrape and poke the inner wall of the conduit causing irritation. Repeated trauma to the conduit tissue may then lead to inflammation, infection, or further hospitalization and increased costs to the patient and healthcare system.

[0003] Indwelling catheters for administration of intravenous therapy can be fitted with extension tubing to allow for self-administration. Such extension tubing can protrude from the body in a range of lengths, for example, 12 inches, 13 inches, or more. If left unsecured, this protuberance of extraneous tubing may pose a risk to snagging or catching of the tubing against objects as the user goes about their daily life. The risk is then extended to events such as catheter pullout and related sequelae. [0004] Techniques for self-managing this extension tubing may include manually coiling the tubing with one hand (when the line is placed within an arm) while balancing the coil against the body, then taping the tubing to the skin with one hand, and then covering the tubing with a tensor bandage in order to maintain the tubing against the body, again with one hand. Such techniques are crude, often uncomfortable, and unnecessarily challenging to the user.

[0005] Devices are referred to in U.S. Patent No. 10328242 - Conduit Management Device, U.S. Patent No. 9486613 - Catheter Securement Device with Slit Between First and Second Pull Tabs, and U.S. Patent No. 10232145 - Medical Device Securement System and Method.

[0006] The present examples herein of a device and method can provide improvement and other known securement techniques. One improvement can include a decreased profile of the securement device. Another improvement can include enhanced ease of use for managing excess lengths of medical tubing, particularly in the case of self-administration of IV therapy.

[0007] In some examples, the present device can contain an anchor which may hinge between an open and closed position. The anchor can provide contact points for tubing to be wrapped around one or more times, to manage the tubing.

[0008] In some examples, the present device discussed herein can contain hook-and-loop fasteners on the distal ends of the anchor, allowing for releasable attachment to the mating hook-and-loop component attached to a base of the securement device. The fasteners on the anchor can contain a tab for gripping the anchor to pull and release the anchor from the base of the securement device.

[0009] In some examples, the anchor of the present device can be constructed of a thin sheet of polymer or elastomeric material cut into a pattern that allows for appropriate hinging, without causing plastic deformation to any portion of the device. This construction may allow for the device to have a low profile, reducing the likelihood of the device interfering with a patient during daily activity.

[0010] Accordingly, there exists a need for an easily replaceable, self- manageable and easy-to-use device that a patient may employ to rapidly secure their catheter tubing in a comfortable, discreet, and effective manner. SUMMARY

[0011] Embodiments described herein provide a tubing securement device that securely anchors tubing to a patient’s skin while at the same time allowing the tubing to be easily removed from the anchor without disturbing the tubing, or any catheter or catheter insertion site related to the tubing. The present tubing securement device is designed to be used to secure extension tubing for drainage of fluids or infusion of therapies and the like. For example, one intended use of the present tubing securement device is to secure extension tubing for PICCs (Peripherally Inserted Central Catheters), but the tubing securement device may be used to secure any extension tubing that protrudes from a patient. The present tubing securement device prevents stresses applied to the extension tubing (when not in use) from transferring to the catheter insertion site and causing catheter migration or removal as well as insertion site irritation.

[0012] Embodiments described herein provide a tubing securement device for releasably securing tubing to a patient by allowing for winding of said tubing, comprising: an elongate flexible base having a first base side and a second base side opposite the first, wherein the first base side is configured to affix to the patient's body, and the second base side is configured to provide a bearing surface for tubing support; an elongate flexible anchor having an anchor top side, an anchor bottom side opposite the top, and at least one hinged section; an anchor securement having a first securement portion adjacent to said hinged section, a second securement portion adjacent to said second base side, and a tab, wherein said first and second securement portions are configured to be releasably mated to each other; the hinged section of the flexible anchor further configured to adopt an open configuration when the anchor securement is not in mated contact, and a closed configuration when the anchor securement is in mated contact, wherein said closed configuration securely holds said tubing, and wherein said open configuration allows for winding or unwinding of said tubing. [0013] In some embodiments, the elongate flexible anchor is elevated above the elongate flexible base by a boss having a first boss face, a boss height, and a second boss face opposite the first, wherein the first boss face is adjacent to the second base side of the elongate flexible base, and the second boss face is adjacent the anchor bottom side.

[0014] In some embodiments, the second base side, said hinged section, and said boss define a space which tubing may occupy when secured.

[0015] In some embodiments, the elongate flexible base has a layer of adhesive material to affix to the patient's body. [0016] In some embodiments, the elongate flexible base has a portion of strapping.

[0017] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of hook and loop fastener.

[0018] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of snap-fit fastener.

[0019] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of magnetic material.

[0020] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of a latch. [0021] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of a peg within a hole.

[0022] Embodiments described herein provide a tubing securement device for releasably securing tubing to a patient by allowing for winding of said tubing, comprising: an elongate flexible base having a first base side and a second base side opposite the first, wherein the first base side is configured to affix to the patient's body, and the second base side is configured to provide a bearing surface for tubing support; an elongate flexible anchor having an anchor top side, and an anchor bottom side opposite the top; an anchor securement having a first securement portion and a second securement portion, wherein said first and second securement portions are configured to be releasably mated to each other; wherein the flexible anchor is configured to adopt an open configuration when the anchor securement is not in mated contact, and a closed configuration when the anchor securement is in mated contact, wherein said closed configuration securely holds said tubing, and wherein said open configuration allows for winding or unwinding of said tubing.

[0023] In some embodiments, the elongate flexible anchor is elevated above the elongate flexible base by a boss having a first boss face, a boss height, and a second boss face opposite the first, wherein the first boss face is adjacent to the second base side of the elongate flexible base, and the second boss face is adjacent the anchor bottom side.

[0024] In some embodiments, the second base side and said boss define a space which tubing may occupy when secured.

[0025] In some embodiments, the elongate flexible base has a layer of adhesive material to affix to the patient's body.

[0026] In some embodiments, the elongate flexible base has a portion of strapping. [0027] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of hook and loop fastener.

[0028] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of snap-fit fastener.

[0029] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of magnetic material.

[0030] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of a latch. [0031] In some embodiments, the first and second securement portions of the anchor securement comprise cooperating portions of a peg within a hole.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 shows a perspective view of an example of a tubing securement device;

[0033] FIG. 2 shows an exploded view of an example of a tubing securement device of FIG. 1;

[0034] FIG. 3A shows a perspective view of the exemplary tubing securement device of FIG. 1 in the open configuration; [0035] FIG. 3B shows a perspective view of the exemplary tubing securement device of FIG. 1 in the closed configuration;

[0036] FIG. 4 shows an example of a flexible anchor of the tubing securement device of FIG. 1;

[0037] FIGS. 5 and 6 show anatomical placement of the exemplary tubing securement device of FIG. 1:

[0038] Corresponding reference characters indicate corresponding parts throughout the several views. Elements in the drawings are not necessarily drawn to scale. The configurations shown in the drawings are merely examplary, and should not be construed as limiting the scope of the invention in any manner. DETAILED DESCRIPTION

[0039] Referring now to the drawings in detail, an improved tubing securement device and method are discussed herein. The device can releasably secure tubing such as medical tubing intended for long term use, to a patient’s body. The device can releasably secure tubing to a patient by allowing for winding of the medical tubing. The device can have securement portions that can be releasably mated to each other to adopt an open configuration when the securement is not in mated contact, and a closed configuration when the securement is in mated contact. The closed configuration securely holds the tubing, and the open configuration allows for winding or unwinding of the tubing. Some example advantages provided by allowing for winding or unwinding of the tubing may include, but are not limited to: low profile and secure organization of the tubing; accommodation of variable lengths of tubing; prevention of tubing kinking or other introduction of strain or unfavorable loading to the tubing; improved ease of use and allowance for single-handed operation and placement of tubing; and the ability to easily hide the tubing from view by orienting it in an area-minimized configuration;

[0040] FIG. 1 shows a perspective view of an exemplary embodiment of a tubing securement device 10. In some examples, the device can be used to secure medical tubing including (but not limited to): PICC extension tubing (element 75 tubing, element 200 PICC line of FIGS. 5 and 6), CVC tubing, and Foley catheter tubing, or other tubing the like thereof.

[0041] Also shown in the exemplary embodiment of the tubing securement device 10 of FIG. 1 is an elongate flexible anchor 20 having a plurality of hinged sections 25, and a plurality of anchor securements 30. Each anchor securement 30 may have a first securement portion 40, and a tab 35 for grabbing onto when operating the device between a closed and open configuration (seen in FIGS. 3A and 3B). The anchor securement 30 may also have a second securement portion (element 45, FIG. 2) that fastens to the first securement portion 40 when in the closed configuration. In some example embodiments, instead of, as or in addition to the hinged section 25, the elongate flexible anchor 20 can have a flexible or flexing member that can deformably bend between an open and closed configuration. In some example embodiments, the tab 35 can be an extension of the securement portions 40, 45. And then any portion beyond the portion being secured would be the portion that can be referred to as a tab 35. [0042] The elongate flexible anchor 20 has an anchor top side, and an anchor bottom side opposite the top. The elongate flexible anchor 20 has at least one hinged section 25. The anchor securement 30 has a first securement portion 40 adjacent to the hinged section 25. The second securement portion adjacent (element 45, FIG. 2) can be adjacent to the second base side, and a tab 35. The first and second securement portions 40, 45 are configured to be releasably mated to each other. The hinged section 25 of the flexible anchor 20 is further configured to adopt an open configuration when the anchor securement 30 is not in mated contact, and a closed configuration when the anchor securement 30 is in mated contact. The closed configuration securely holds tubing. The open configuration allows for winding or unwinding of the tubing.

[0043] FIG. 2 shows an exploded view of the tubing securement device 10, and further details an elongate flexible base 50 of the tubing securement device 10. The elongate flexible base 50 has a first base side 60 which supports each of the second securement portions 45, and a boss 55. The elongate flexible base 50 may also have a second base side 65 which has an adhesive layer (not shown) that adheres to a patient’s skin on contact. The elongate flexible base 50 a base top side, and a base bottom side opposite the top. The second base side 65 is opposite the first base side 60. This example view shows the first base side 60 as a base top side and the second base side 65 is a base bottom side, underneath the top. The boss 55 provides location and support for the elongate flexible anchor 20, and acts as a spool for tubing when the device is in the closed configuration. The elongate flexible base 50 may be comprised of materials such as silicone, hydrocolloid, fabrics, stick-to-skin adhesives, or any other suitably flexible material the like thereof, or any combination of these materials or other suitably flexible materials.

[0044] In this example, the second base side 65 is configured to affix to the patient’s body, and the first base side 60 is configured to provide a bearing surface for tubing support. In other examples, the first base side 60 can be configured to affix to the patient’s body, and the second base side 65 can be configured to provide a bearing surface for tubing support. [0045] In some embodiments, the elongate flexible anchor 20 is elevated above the elongate flexible base 50 by a boss 55 having a first boss face, a boss height, and a second boss face opposite the first. The first boss face can be adjacent to the second base side of the elongate flexible base 50, and the second boss face can be adjacent the anchor bottom side. The second base side, the hinged section 25, and the boss 55 define a space which tubing may occupy when secured.

[0046] In some embodiments, the elongate flexible base 50 has a layer of adhesive material. In some embodiments, the elongate flexible base 50 has a portion of strapping. [0047] In some embodiments, the first and second securement portions 40, 45 of the anchor securement 30 comprise cooperating portions of hook and loop fastener. In some embodiments, the first and second securement portions 40, 45 of the anchor securement 30 comprise cooperating portions of snap-fit fastener. In some embodiments, the first and second securement portions 40, 45 of the anchor securement 30 comprise cooperating portions of magnetic material. In some embodiments, the first and second securement portions 40, 45 of the anchor securement 30 comprise cooperating portions of a latch. In some embodiments, the first and second securement portions 40, 45 of the anchor securement 30 comprise cooperating portions of a peg within a hole. [0048] FIGS. 3A and 3B show a side-by-side view of the tubing securement device of FIG. 1 in the closed 110 (FIG. 6) and open 100 (FIG. 5) configurations. FIG. 3A shows the tubing securement device of FIG. 1 in the open configuration. FIG. 3B shows the tubing securement device of FIG. 1 in the closed configuration. For example, the hinged section 25 of the flexible anchor 20 is further configured to adopt an open configuration when the anchor securement 30 is not in mated contact. The hinged section 25 of the flexible anchor 20 is further configured to adopt a closed configuration when the anchor securement 30 is in mated contact. The closed configuration securely holds tubing. The open configuration allows for winding or unwinding of the tubing. [0049] The closed configuration 110 can be the configuration during periods when tubing must be secured. The open configuration 100 can be the configuration during periods when tubing must be accessible, such as during tubing release for therapy infusion. [0050] FIG. 4 shows the elongate flexible anchor 20 with hinged sections 25 extending laterally from the portion above the boss 70. A plurality of slots 80 are provided for hinging of the hinged sections 25 relative to the portion of the anchor above the boss 70.

[0051] FIGS. 5 and 6 show anatomical placement of the exemplary tubing securement device of FIG. 1: In FIG. 5, medical tubing has been wrapped around the exemplary securement device anchor, and the device is in the open configuration 100; and in FIG. 6, the device is in the closed configuration 110 with the tubing secured.

[0052] Although the invention has been described by reference to a specific embodiment, it should be understood that numerous changes may be made within the spirit and scope of the inventive concepts described. Accordingly, it is intended that the invention not be limited to the described embodiment, but that it have the full scope defined by the language of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A tubing securement device for releasably securing tubing to a patient by allowing for winding of said tubing, comprising: an elongate flexible base having a first base side and a second base side opposite the first, wherein the first base side is configured to affix to the patient’s body, and the second base side is configured to provide a bearing surface for tubing support; an elongate flexible anchor having an anchor top side, an anchor bottom side opposite the top, and at least one hinged section; an anchor securement having a first securement portion adjacent to said hinged section, a second securement portion adjacent to said second base side, and a tab, wherein said first and second securement portions are configured to be releasably mated to each other; the hinged section of the flexible anchor further configured to adopt an open configuration when the anchor securement is not in mated contact, and a closed configuration when the anchor securement is in mated contact, wherein said closed configuration securely holds said tubing, and wherein said open configuration allows for winding or unwinding of said tubing.

2. The tubing securement device of claim 1 , wherein the elongate flexible anchor is elevated above the elongate flexible base by a boss having a first boss face, a boss height, and a second boss face opposite the first, wherein the first boss face is adjacent to the second base side of the elongate flexible base, and the second boss face is adjacent the anchor bottom side.

3. The tubing securement device of claim 2, wherein said second base side, said hinged section, and said boss define a space which tubing may occupy when secured.

4. The tubing securement device of claim 3, wherein the elongate flexible base has a layer of adhesive material to affix to the patient’s body.

5. The tubing securement device of claim 3, wherein the elongate flexible base has a portion of strapping.

6. The tubing securement device of any one of claims 4 to 5, wherein the first and second securement portions of the anchor securement comprise cooperating portions of hook and loop fastener.

7. The tubing securement device of any one of claims 4 to 5, wherein the first and second securement portions of the anchor securement comprise cooperating portions of snap-fit fastener.

8. The tubing securement device of any one of claims 4 to 5, wherein the first and second securement portions of the anchor securement comprise cooperating portions of magnetic material.

9. The tubing securement device of any one of claims 4 to 5, wherein the first and second securement portions of the anchor securement comprise cooperating portions of a latch.

10. The tubing securement device of any one of claims 4 to 5, wherein the first and second securement portions of the anchor securement comprise cooperating portions of a peg within a hole.

11. A tubing securement device for releasably securing tubing to a patient by allowing for winding of said tubing, comprising: an elongate flexible base having a first base side and a second base side opposite the first, wherein the first base side is configured to affix to the patient’s body, and the second base side is configured to provide a bearing surface for tubing support; an elongate flexible anchor having an anchor top side, and an anchor bottom side opposite the top; an anchor securement having a first securement portion and a second securement portion, wherein said first and second securement portions are configured to be releasably mated to each other; wherein the flexible anchor is configured to adopt an open configuration when the anchor securement is not in mated contact, and a closed configuration when the anchor securement is in mated contact, wherein said closed configuration securely holds said tubing, and wherein said open configuration allows for winding or unwinding of said tubing.

12. The tubing securement device of claim 11 , wherein the elongate flexible anchor is elevated above the elongate flexible base by a boss having a first boss face, a boss height, and a second boss face opposite the first, wherein the first boss face is adjacent to the second base side of the elongate flexible base, and the second boss face is adjacent the anchor bottom side.

13. The tubing securement device of claim 12, wherein said second base side and said boss define a space which tubing may occupy when secured.

14. The tubing securement device of claim 13, wherein the elongate flexible base has a layer of adhesive material to affix to the patient’s body.

15. The tubing securement device of claim 13, wherein the elongate flexible base has a portion of strapping.

16. The tubing securement device of any one of claims 14 to 15, wherein the first and second securement portions of the anchor securement comprise cooperating portions of hook and loop fastener.

17. The tubing securement device of any one of claims 14 to 15, wherein the first and second securement portions of the anchor securement comprise cooperating portions of snap-fit fastener.

18. The tubing securement device of any one of claims 14 to 15, wherein the first and second securement portions of the anchor securement comprise cooperating portions of magnetic material.

19. The tubing securement device of any one of claims 14 to 15, wherein the first and second securement portions of the anchor securement comprise cooperating portions of a latch.

20. The tubing securement device of any one of claims 14 to 15, wherein the first and second securement portions of the anchor securement comprise cooperating portions of a peg within a hole.