Medical device securement system and method
11565083 · 2023-01-31
Assignee
Inventors
Cpc classification
A61M2025/0246
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
A61M2005/1586
HUMAN NECESSITIES
International classification
Abstract
A medical device securement system is configured to secure medical devices such as catheters in place. The securement system includes an anchor pad that attaches to a patient's skin. A malleable support base is attached to an upper surface of the anchor pad. The support base has front and back inclined surfaces that are separated by an offset surface that extends generally normal to both of the inclined surfaces. A spot of adhesive is applied to one or more of the inclined surfaces. A catheter assembly includes a connector having a first connector portion with a diameter larger than an adjacent second structure. The catheter assembly is attached to the support base with the first connector portion engaged with and supported by the back inclined surface, and the second connector portion engaged with and supported by the front inclined surface.
Claims
1. A medical article securement device, comprising; a support base having a bottom surface, a first upper surface, a second upper surface, an offset surface, opposing side surfaces, a front wall and a back wall; the first upper surface and second upper surface being longitudinally one behind the other; the offset surface disposed between the first and second upper surfaces; the opposing side surfaces extending from the bottom surface to the first and second upper surfaces and terminating upon intersecting the first and second planar upper surfaces; the front wall extending from the bottom surface to the first upper surface and terminating upon intersecting the first upper surface; and the back wall extending from the bottom surface to the second upper surface and terminating upon intersecting the second upper surface.
2. The medical securement device of claim 1, wherein the first upper surface terminates upon intersecting the offset surface and the second upper surface terminates upon intersecting the offset surface so that the first upper surface, offset surface and second upper surface collectively define a contiguous upper surface.
3. The medical securement device of claim 2, additionally comprising an anchor pad configured to be adhered to skin of a patient, the support base bottom surface being attached to an upper surface of the anchor pad.
4. The medical securement device of claim 3, wherein each of the opposing side surfaces is planar.
5. The medical securement device of claim 4, wherein each of the opposing side surfaces is normal to the bottom surface.
6. The medical securement device of claim 5, wherein the first and second upper surfaces are both inclined and non-normal relative to the bottom surface.
7. The medical securement device of claim 1, additionally comprising an adhesive layer disposed over only a portion of a width of the second upper surface.
8. The medical securement device of claim 7, wherein there is no adhesive layer on the first upper surface.
9. The medical securement device of claim 1, wherein the bottom surface lies in a bottom plane, and the second upper surface is inclined and non-normal relative to the bottom plane, and the back wall intersects the second upper surface at a high point, and wherein no part of the support base is spaced farther from the bottom plane than is the high point.
10. The medical securement device of claim 9, wherein the back wall intersects the second upper surface along an elongated back intersect line, and the high point is defined on the back intersect line.
11. The medical securement device of claim 10, wherein the back intersect line is parallel to the bottom plane.
12. The medical securement device of claim 11, wherein the second upper surface is planar.
13. A medical article securement device, comprising; an anchor pad configured to be adhered to skin of a patient; a support base comprising a first portion and a second portion that are formed independently from one another, each of the first and second portions having a bottom surface; the first portion having a first portion upper surface, the second portion having a second portion upper surface; and the bottom surfaces of the first portion and the second portion being attached to the anchor pad so that the second portion is longitudinally behind the first portion and a back wall of the first portion is adjacent a front wall of the second portion.
14. The medical article securement device of claim 13, wherein each of the first portion and the second portion have opposing side surfaces, and wherein the opposing side surfaces extend from the respective bottom surfaces to the respective one of the first portion upper surface and second portion upper surface and terminate upon intersecting the respective one of the first portion upper surface and second portion upper surface.
15. The medical article securement device of claim 13, wherein the first portion upper surface and the second portion upper surface are both planar.
16. The medical article securement device of claim 15, wherein the first portion upper surface and the second portion upper surface are both parallel to an upper surface of the anchor pad.
17. The medical article securement device of claim 16, wherein one of the first portion upper surface and second portion upper surface is spaced farther from the upper surface of the anchor pad than is the other of the first portion upper surface and second portion upper surface.
18. The medical article securement device of claim 13, wherein the first portion has a first malleability and the second portion has a second malleability, and the first malleability is different from the second malleability.
19. The medical article securement device of claim 13, wherein the first portion is formed of a different material than is the second portion.
20. A method, comprising: providing a medical line assembly having a connector that is releasably attached to a hub, the connector having a first diameter, the hub having a second diameter that is less than the first diameter; attaching a securement device to the skin of a patient, the securement device comprising a first support portion and a second support portion that are formed separately from one another and arranged so that a back wall of the first support portion is adjacent a front wall of the second support portion; resting the hub and connector on the first and second support portions so that the hub is in contact with and supported by an upper surface of the first support portion, the connector is in contact with and supported by an upper surface of the second support portion, and a distal end of the connector is in contact with the back wall of the first support portion.
21. The method of claim 20, wherein the first support portion and second support portion are attached to an anchor pad, and attaching the securement device to the skin of the patient comprises adhering the anchor pad to the skin of the patient.
22. The method of claim 20, wherein an adhesive is disposed on the upper surface of the second support portion but not on the upper surface of the first support portion, and additionally comprising engaging the connector with the adhesive without engaging the hub with any adhesive.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION
(21) The following description and the accompanying figures describe and show embodiments that serve as illustrative examples of medical device securement systems and associated methods, including various inventive aspects and features. The illustrated embodiments are made in connection with a catheter assembly. Illustration of the securement system in this context is not intended to limit the disclosed aspects and features to the specific embodiments or to imply that such aspects and features can be used only with the illustrated catheter assembly. Those of skill in the art will recognize that the disclosed aspects and features are not limited to any particular embodiment of a securement system, and securement systems that include one or more of the inventive aspects and features described herein can be used in connection with a variety of medical articles.
(22) With initial reference to
(23) With reference next to
(24) The anchor pad 60 preferably has a laminate structure with an upper layer 70 and a lower adhesive layer 72. In one preferred embodiment, the upper layer 70 comprises a woven polyester material commercially available from Tyco under the name “Tricot.” It is to be understood, however, that other embodiments may employ woven or nonwoven polymer or non-polymer textile materials. In yet further embodiments the upper layer may be constructed of paper or foam.
(25) The lower adhesive layer 72 is configured to adhere the anchor pad 60 to the skin of the patient, and can include a medical grade adhesive that is either diaphoretic or non-diaphoretic, depending upon the particular application. In some embodiments the lower adhesive layer 72 may include additional types of medical adhesives. Also, some embodiments of the lower adhesive layer 72 may comprise anti-bacterial or anti-microbial material such as a legal dynamic metal salts or oxides, or combinations thereof. The adhesive layer 72 may be a solid layer or may be configured as an intermittent layer such as in the pattern of spots or strips.
(26) A removable release liner 74 preferably covers the adhesive layer 72 before use. The release liner 74 may be configured as a single piece, or may be divided into two or more adjacent pieces in order to may make removal easier. The release liner 74 can be made of any of several materials, including paper, polymers, or combinations thereof. In one embodiment, the release liner 74 may comprise a material made of poly coated, siliconized paper, or another suitable material such as high density polyethylene, polypropylene, polyolefin, or silicon coated paper.
(27) A catheter support base 80 is attached to the upper layer 70 of the anchor pad 60. The support base 80 preferably comprises a malleable, compressible material such as a polyethylene foam or any of several other compressible foams. As shown, preferably the support base 80 is attached to the upper layer 70 so that a front wall 82 of the support base 80 is adjacent the front edge 62 of the anchor pad 60 in the cavity 66, and a back wall 84 of the support base 80 is positioned adjacent the back edge 64 of the anchor pad 60. Preferably the support base 80 is aligned with the axis 68 of the anchor pad 60.
(28) Continuing with reference to
(29) With particular reference to
(30) In the illustrated embodiment, a thickness 93 of the support base 80 at the front edge 87 of the front inclined surface 86 is greater than a thickness 95 of the support base at a front edge 91 of the back inclined surface 90, and a thickness 97 of the support base at the back edge 88 of the first inclined surface 86 is greater than a thickness 99 of the back edge 92 of the second inclined surface 90. It is to be understood, however, that in other embodiments these relationships could be reversed or configured otherwise.
(31) With particular reference next to
(32) A release liner 102 preferably is applied to the adhesive layer 100. The release liner 102 can be formed from various materials, as is the release liner 74 of the anchor 60, and can have various shapes and sizes. For example in the embodiment illustrated in
(33) As noted above, the anchor pad 60 helps secure a catheter assembly 30 in place on the patient. The clinician may use standard venipuncture procedures to place the catheter tube 32 into a patient's vasculature, and then attach a fluid delivery line 41 to the catheter.
(34) With reference next to
(35) In another embodiment, one or more sutures can be applied to secure the catheter assembly 30 to the support base 80. More specifically, the clinician may suture into the support base rather than suturing into the patient's skin. As such, the suture would secure the catheter assembly to the support base. In some embodiments, such a suture can be applied in addition to adhesive placed on the front or back inclined surfaces. In additional embodiments, no adhesive, or a very weak adhesive, is applied to one or more of the front and back inclined surfaces, and the suture extending through the support base and tied around the catheter assembly secures the catheter assembly to the support base. In still additional embodiments, an adhesive can be applied to one or the other of the front and back inclined surfaces, and a suture can be placed in the other of the front and back inclined surfaces.
(36) In the illustrated embodiment, the offset surface 89 approximates the difference in diameter between the spin nut 50 and the catheter hub 40. As such, the offset surface 89 improves the fit of the catheter assembly 30 on the support pad 80. Further, the offset surface 89 engages a distal end of the spin nut 50, thereby blocking the catheter assembly 30 from moving distally. The adhesive layer 100 provides stable securement of the catheter assembly 30 to the support base 80, and also resists movement of the assembly proximally, or in any direction. The malleable support base 80 accommodates hard portions of the catheter assembly 30, lifting them from the patient's skin 110. Also, deformation of the foam support base 80 absorbs and/or spreads out force is applied by contact points of the catheter assembly 30. As such, the illustrated configuration improves patient comfort.
(37) In one embodiment, the adhesive layer 100 may be tacky but not necessarily tacky enough to hold the catheter assembly 30 in place on the securement device 55 without assistance in the long-term. With reference next to
(38) In the embodiment illustrated in
(39) With continued reference to
(40) With reference next to
(41) Continuing with reference to
(42) With reference again to
(43) It is to be understood, however, that in other embodiments the glue dot can be placed on only the front inclined surface 86. In further embodiments, glue dots can be placed on both the front and back inclined surfaces 86, 90. Still additional embodiments may employ a glue dot on the offset surface 89 instead of or in addition to glue dots being placed on one, the other, or both of the front and back inclined surfaces.
(44) With additional reference to
(45) A clinician can change a dressing employing the illustrated securement device 55. For example, the Tegaderm™ transparent dressing can be removed and then the spin nut 50 can be pulled off of the support base 80. Preferably the glue dot 100b is configured to preferentially stick to the foam support base 80 so that the glue dot 100b does not stick to the spin nut 50. The spin nut 50 can then be disconnected from the catheter hub 40 so that the associated IV line 42 can be discarded and replaced, while the catheter hub 40 and associated catheter tube 32 can remain in place. Since the hub 40 was never adhered to the support base 80 in this embodiment, there would be no adhesive residue on the surface of the catheter hub 40. The securement device 55 can be peeled off of the patient's skin and replaced with a fresh, sterile securement device 55. A new Luer connector 44 and associated IV line 42 can also be attached to the catheter hub 40. The spin nut 50 of the replacement Luer connector 44 can then be attached via the glue dot 100b to the back inclined surface 90 of the fresh securement device, and a fresh cover dressing 114 can then be placed over the assembly.
(46) With reference next to
(47) In yet additional embodiments, the support base may not have an undulating shape with one, two, or more inclined surfaces. For example, with reference next to
(48) With reference next to
(49) With reference next to
(50) With continued reference to
(51) The embodiments described above have employed a catheter assembly with a particular hub design and Luer connector design. It is be understood, however, that embodiments employing the principles discussed above can have somewhat different specific structure in order to accommodate catheters or medical devices with different applications. For example, some catheters that will have somewhat different structure but may still employee principles discussed herein, include central venous catheters, peripherally inserted central catheters, hemodialysis catheters, and Foley catheters. Such other types of catheters may entail different designs and structure for catheter hubs and connectors. Other medical articles having connectors that connect the article to fluid delivery tubes may also employ securement devices exhibiting the principles discussed herein including for example, surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes, rectal drains, external ventricular drains, chest tubes, or any other sort of medical lines, particularly lines with connector fittings.
(52) The embodiments discussed above have disclosed structures with substantial specificity. This has provided a good context for disclosing and discussing inventive subject matter. However, it is to be understood that other embodiments may employ different specific structural shapes and interactions.
(53) Although inventive subject matter has been disclosed in the context of certain preferred or illustrated embodiments and examples, it will be understood by those skilled in the art that the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the disclosed embodiments have been shown and described in detail, other modifications, which are within the scope of the inventive subject matter, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments may be made and still fall within the scope of the inventive subject matter. For example, the features concerning materials that can be used in the support base as disclosed in the embodiments depicted in