Medical securement dressing with reinforcement element

Abstract

A medical securement dressing includes a backing defined by a backing outer perimeter, a first major surface, and an opposing second major surface. A portion of the backing outer perimeter defines a medical article exit feature region of the backing. A polymeric film forms at least a portion of the first major surface. A first pressure sensitive adhesive is disposed on at least a portion of the second major surface. A reinforcement element is disposed on only a portion of the first pressure sensitive adhesive. The reinforcement element defined by an outer perimeter co-incident with the medical article exit feature defining the notch. A second pressure sensitive adhesive is disposed on the reinforcement element. A carrier is defined by a carrier outer perimeter and a carrier inner perimeter. The carrier inner perimeter defines a carrier window. The carrier is releasably bonded to the polymeric film.

Description

PA200218W0002MEDICAL SECUREMENT DRESSING WITH REINFORCEMENT ELEMENTFIELD OF INVENTION

[0001] The present disclosure relates to medical dressings, and more particularly to a medical securement dressings that include a reinforcement element.BACKGROUND

[0002] Medical securement dressings are adhesive-based medical articles configured to stabilize and protect indwelling medical articles such as intravenous (IV) catheters, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), arterial lines, enteral feeding tubes, and similar devices at their insertion sites. These dressings generally comprise a conformable base layer formed of a flexible polymeric film, fabric, or composite material having sufficient tensile strength to maintain device position during patient movement. The base layer is typically coated, in whole or in part, with a medical-grade adhesive formulated to provide sustained adherence to skin surfaces for durations ranging from 24 hours to several days, while permitting atraumatic removal to minimize epidermal stripping or irritation.

[0003] The dressing may include a transparent or translucent central window portion to enable direct visual inspection of the insertion site without removal, thereby reducing disruption of the sterile field and lowering the risk of catheter-related bloodstream infections. Certain configurations incorporate anchoring elements — such as reinforced panels, integrated straps, or molded retention members — to further secure the device hub or tubing and reduce micromotion. Optional features may include absorbent pads for exudate management, antimicrobial-impregnated components to inhibit microbial colonization, and moisturevapor-permeable films to maintain skin health while providing a barrier to liquids, bacteria, and viruses.

[0004] Securement dressings are commonly supplied in pre-sterilized, single-use form and may be configured with peel-away liners and application tabs to facilitate aseptic placement. Dimensions and geometries can vary to accommodate different anatomical locations and device types, with shapes ranging from rectangular to anatomically contoured designs. In clinical use, these dressings maintain medical article stability, prolong dwell time, and improve patient comfort, thereby reducing the incidence of unintentional device removal and insertion-site complications.PA200218W0002

[0005] Thin polymeric films that are flexible and resilient are beneficial when used on skin that flexes, stretches, and retracts. However, for some applications, like when securing medical articles such as tubing, ports, and catheters, the high flexibility and resiliency of the thin polymeric film can allow or permit unwanted movement of the secured medical article. Therefore, medical dressings have been developed that further incorporate areas having secured to the thin polymeric film, stiffer, less conformable materials such as adhesives, films, or fabrics. For example, U.S. Pat. No. 5,088,483 discloses an adhesive composite dressing that includes a conformable backing and a permanent adhesive reinforcement around the periphery of the adhesive composite. One example of a commercially available medical dressing with a reinforcement layers is TEGADERM™ IV Advanced Dressing (3M Company, St. Paul Minn.).

[0006] Medical securement dressings with thin polymeric films provide many benefits of enhanced conformability, however, these dressings may allow the secured medical article to move or be dislodged when force is applied to the secured medical article. Medical securement dressings with improved securement while maintaining conformability is desired.SUMMARY

[0007] The present disclosure relates to medical dressings, and more particularly to medical securement dressings that include a reinforcement element. The reinforcement element may be selectively disposed in the medical securement dressing at the contact point of the medical article exiting the perimeter of the medical securement dressing.

[0008] The medical securement dressing may include a reinforcement element selectively disposed at the medical article exit feature of the medical securement dressing backing. The reinforcement element may have a portion of its’ outer perimeter co-incident with the medical article exit feature of the medical securement dressing backing.

[0009] The medical securement dressing includes a reinforcement element disposed at a portion of the dressing that is subject to concentrated forces generated by the medical article secured by the dressing. Such forces may arise from the weight of the article, tensile loads transmitted through connected tubing, or patient movement causing torque or shear stresses at the device interface. The reinforcement element is configured to locally strengthen the dressing structure in these high-stress regions, thereby reducing the riskPA200218W0002 of tearing, delamination, or adhesive failure and ensuring stable retention of the medical article throughout the intended wear period.

[0010] According to an aspect of the present disclosure, a medical securement dressing includes a backing defined by a backing outer perimeter, a first major surface and an opposing second major surface. A portion of the backing outer perimeter defines a medical article exit feature region of the backing. A polymeric film forms at least a portion of the first major surface. The medical article exit feature defines a notch extending into the backing a notch length value. A first pressure sensitive adhesive is disposed on at least a portion of the second major surface. A reinforcement element is disposed on only a portion of the first pressure sensitive adhesive. The reinforcement element is defined by an outer perimeter co-incident with the medical article exit feature defining the notch. A second pressure sensitive adhesive is disposed on the reinforcement element. A carrier is defined by a carrier outer perimeter and a carrier inner perimeter, the carrier inner perimeter defining a carrier window. The carrier is releasably bonded to the polymeric film. The carrier is formed of a material more rigid than the polymeric film.

[0011] According to another aspect of the present disclosure, a medical securement dressing includes a backing defined by a backing outer perimeter, a first major surface and an opposing second major surface. A portion of the backing outer perimeter defines a medical article exit feature region of the backing. A polymeric film forms at least a portion of the first major surface. The medical article exit feature defines a notch extending into the backing a notch length value. A first pressure sensitive adhesive is disposed on at least a portion of the second major surface. A reinforcement element is disposed on only a portion of the first pressure sensitive adhesive. The reinforcement element is defined by an outer perimeter co-incident with the medical article exit feature defining the notch. The reinforcement element has a length value that is parallel with the notch length and a width value that is parallel with a notch width, and the reinforcement element width value is greater than the notch width value but less than five times the notch width value. A second pressure sensitive adhesive is disposed on the reinforcement element. A carrier is defined by a carrier outer perimeter and a carrier inner perimeter, the carrier inner perimeter defining a carrier window. The carrier is releasably bonded to the polymeric film. The carrier is formed of a material more rigid than the polymeric film.PA200218W0002

[0012] The medical article exit feature region of the backing is subject to concentrated forces generated by the medical article secured by the dressing. The reinforcement element is localized to the medical article exit feature region of the backing to locally strengthen the dressing structure in this high- stress region, thereby reducing the risk of tearing, delamination, or adhesive failure and ensuring stable retention of the medical article throughout the intended wear period.

[0013] By providing the reinforcement element just where it is needed, the reinforcement element improves the durability and reliability of the securement dressing while selectively fortifying the medical article exit feature area most prone to stress, while still allowing the remainder of the dressing to remain thin, flexible, and breathable. This localized reinforcement improves device stability, minimizes risk of dislodgement, and enhances patient safety without substantially compromising comfort or skin health.

[0014] The foregoing general description of the illustrative embodiments and the following detailed description thereof are merely exemplary aspects of the teachings of this disclosure and are not restrictive.BRIEF DESCRIPTION OF FIGURES

[0015] Non-limiting and non-exhaustive examples are described with reference to the following figures.

[0016] FIG. 1 is a schematic diagram top view of one embodiment of a medical securement dressing.

[0017] FIG. 2 is a schematic diagram top view of one embodiment of a medical securement dressing with the carrier removed.

[0018] FIG. 3 is a schematic diagram top view of tape strip element with reinforcing element for use with the medical securement dressing described herein.

[0019] FIG. 4 is a schematic diagram exploded view of another embodiment of a medical securement dressing.

[0020] FIG. 5 is a schematic diagram top view of applying an illustrative medical securement dressing onto a surface to secure a medical article and deflecting the carrier bridge element.

[0021] FIG. 6 is a schematic diagram top view of removing an illustrative carrier from the polymer film.PA200218W0002

[0022] FIG. 7 is a schematic diagram top view of an illustrative medical securement dressing securing a medical article to a surface.

[0023] These and other embodiments of the present disclosure will be apparent from the detailed description below. In no event, however, should the above summaries be construed as limitations on the claimed subject matter, which subject matter is defined solely by the attached claims, as may be amended during prosecution.DETAILED DESCRIPTION

[0024] The following description sets forth exemplary aspects of the present disclosure. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure. Rather, the description also encompasses combinations and modifications to those exemplary aspects described herein.

[0025] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of any text that follows the heading, unless so specified.

[0026] The terms “comprises”, and variations thereof do not have a limiting meaning where these terms appear in the description and claims. Such terms will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements.

[0027] The words “preferred” and “preferably” refer to embodiments of the disclosure that may afford certain benefits, under certain circumstances; however, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the disclosure.

[0028] In this application, terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one of’ and “comprises at least one of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list.PA200218W0002

[0029] As used herein, the term “or” is generally employed in its usual sense including “and / or” unless the content clearly dictates otherwise.

[0030] The term “and / or” means one or all of the listed elements or a combination of any two or more of the listed elements.

[0031] As used herein in connection with a measured quantity, the term “about” refers to that variation in the measured quantity as would be expected by the skilled artisan making the measurement and exercising a level of care commensurate with the objective of the measurement and the precision of the measuring equipment used. Herein, “up to” a number (for example, up to 50) includes the number (for example, 50).

[0032] Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range as well as the endpoints (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0033] The present disclosure relates to medical dressings, and more particularly to medical securement dressings that include a reinforcement element. The reinforcement element may be selectively disposed in the medical securement dressing at the contact point of the medical article exiting the perimeter of the medical securement dressing.

[0034] The medical securement dressing may include a reinforcement element selectively disposed at the medical article exit feature of the medical securement dressing backing. The reinforcement element may have a portion of its’ outer perimeter co-incident with the medical article exit feature of the medical securement dressing backing.

[0035] The medical securement dressing includes a reinforcement element disposed at a portion of the dressing that is subject to concentrated forces generated by the medical article secured by the dressing. Such forces may arise from the weight of the article, tensile loads transmitted through connected tubing, or patient movement causing torque or shear stresses at the device interface. The reinforcement element is configured to locally strengthen the dressing structure in these high-stress regions, thereby reducing the risk of tearing, delamination, or adhesive failure and ensuring stable retention of the medical article throughout the intended wear period.PA200218W0002

[0036] The reinforcement element may be formed from a material having greater tensile strength, tear resistance, or rigidity than the surrounding backing layer. Suitable materials include woven or nonwoven polyester fabrics, high-density polyethylene films, polyethylene terephthalate (PET) sheets, or laminated composites of polymeric films and fabrics. In some embodiments, the reinforcement element comprises a mesh or scrim structure that permits moisture vapor transmission while distributing mechanical loads across a broader surface area of the dressing. The reinforcement element can be integrated as a discrete patch bonded to the backing layer, or as an embedded layer within a laminate construction, depending on the desired balance between reinforcement and conformability.

[0037] FIG. 1 is a schematic diagram top view of one embodiment of a medical securement dressing 100. FIG. 2 is a schematic diagram top view of one embodiment of a medical securement dressing 100 with the carrier 130 removed. FIG. 3 is a schematic diagram top view of tape strip element 170 with reinforcing element 106 for use with the medical securement dressing 100 described herein. FIG. 4 is a schematic diagram exploded view of another embodiment of a medical securement dressing 100.

[0038] The medical securement dressing 100 includes a backing 110 defined by a backing outer perimeter 112, a first major surface 111 and an opposing second major surface 113. A portion of the backing outer perimeter 112 defines a medical article exit feature 115 region of the backing 110. A polymeric film 118 forms at least a portion of the first major surface 111. The medical article exit feature 115 defines a notch extending into the backing 110 a notch length value LI. A first pressure sensitive adhesive 120 is disposed on at least a portion of the second major surface 113. A reinforcement element 105 is disposed on only a portion of the first pressure sensitive adhesive 120. The reinforcement element 105 is defined by an outer perimeter 104 co-incident with the medical article exit feature 115 defining the notch. A second pressure sensitive adhesive 125 is disposed on the reinforcement element 105. A carrier 130 is defined by a carrier outer perimeter 131 and a carrier inner perimeter 132. The carrier inner perimeter 132 defines a carrier window 133. The carrier 130 is releasably bonded to the polymeric film 118. The carrier 130 is formed of a material more rigid than the polymeric film 118.

[0039] The reinforcement element 105 outer perimeter 104 may not be co-incident with the backing 110 outer perimeter 112 except at the outer perimeter 112 defining the medical article exit feature 115PA200218W0002 region of the backing 110. The reinforcement element 105 outer perimeter 104 is preferably inset from the backing 110 outer perimeter 112 except at the outer perimeter 112 defining the medical article exit feature 115 region of the backing 110. The width W3 of the reinforcement element 105 may be co-incident with the backing 110 outer perimeter 112, while the remainer of the reinforcement element 105 outer perimeter 104 is not co-incident with the backing 110 outer perimeter 112.

[0040] The reinforcement element 105 has a length value L2 that is parallel with the notch length LI and a width value W3 that is parallel with a notch width W1 or W2. The reinforcement element width value W3 is greater than the notch width value W1 or W2 but less than five times the notch width value W1 or W2. 0041] In many embodiments, the polymeric film 118 forms the outer surface of the medical securement dressing 100 once the carrier 130 is removed. The medical securement dressing 100 has a polymeric film 118 outer surface provides advantages such as allowing easy wipe down of the surface and medical securement dressing 100 by the medical professional to ensure sterility.

[0042] In some implementations, a release liner 140 is provided on the adhesive 120, 125, 160 layer forming the bottom layer of the medical securement dressing 100. Optional release liners 140 (illustrated in FIG. 4) may be included that covers all or a portion of the adhesive 120, 125, 160 to prevent contamination of the adhesives. Suitable release liners can be made of kraft papers, polyethylene, polypropylene, polyester or composites of any of these materials. The liners may be coated with release agents such as fluorochemicals or silicones. The release liners may be paper, polyolefin film, or polyester film coated with silicone release materials.

[0043] The backing outer perimeter 112 defines a medical article exit feature 115. The medical article exit feature 115 is configured to allow a medical article that is secured by the medical securement dressing 100 to a surface to exit the backing outer perimeter 112 conveniently. The medical article exit feature 115 may be a slot or a notch feature that extends inwardly toward the center of the medical securement dressing 100.

[0044] The backing 110 of the medical securement dressing 100 serves as a structural and protective component, providing mechanical support to the dressing while acting as a barrier to external contaminants. In many embodiments, the backing 110 is formed from a conformable, waterproof, and moisture-vapor-PA200218W0002 permeable film that permits the passage of water vapor from the skin surface while preventing the ingress of liquids, bacteria, and viruses. This barrier function may maintain a sterile environment at the insertion site of indwelling medical articles such as intravenous catheters, feeding tubes, or central venous lines, for example. The backing 110 may also contributes to the dressing’s overall integrity, allowing it to maintain its form and adherence under conditions of patient movement, perspiration, or incidental mechanical contact.

[0045] Suitable materials for the backing 110 include polyurethane films, polyethylene films, polyethylene terephthalate (PET) films, polyether block amide (PEBA) films, or laminated composites thereof. Polyurethane films are often preferred due to their combination of flexibility, tensile strength, and high moisture vapor transmission rate (MVTR), which supports prolonged wear and skin health. In some embodiments, the backing may be optically transparent or translucent to allow visual inspection of the underlying insertion site, while in others it may be opaque to provide privacy or to shield the site from light exposure.

[0046] The backing 110 or polymeric film 118 may have a thickness in a range from 15 to 100 micrometers. The backing 110 or polymeric film 118 may have a thickness in a range from 15 to 50 micrometers. The backing 110 or polymeric film 118 may have a thickness in a range from 20 to 40 micrometers.

[0047] A first pressure sensitive adhesive 120 is disposed on at least a portion of the second major surface 113. The pressure sensitive adhesive 120 may adhere the medical securement dressing 100 to a surface and a medical article. A release layer may be disposed on or adhered to the pressure sensitive adhesive 120. The first pressure sensitive adhesive 120 may adhere the reinforcement element 105 to the backing 110 or polymeric film 118.

[0048] In some embodiments the backing 110 further includes a support layer 150 and a third adhesive 160 layer. The support layer 150 may be attached to the first adhesive 120 of the backing 110. The support layer 150 may be attached to the adhesive 125 of the reinforcement element 105. The support layer 150 may be attached to both the second adhesive 125 of the reinforcement element 105 and the first adhesive 120 of the backing 110.PA200218W0002

[0049] Adhesive or pressure sensitive adhesive materials used in medical securement dressings are selected to provide reliable fixation of the dressing to the patient’s skin for the intended wear period while minimizing the risk of skin injury or irritation upon removal. Such adhesives must adhere effectively under various clinical conditions without excessive edge lift or premature failure. In addition to strong initial and long-term adhesion, medical adhesives are biocompatible, hypoallergenic to reduce sensitization risk, and compatible with sterilization processes. The adhesive or pressure sensitive adhesive layer may be applied to the skin-facing surface of the backing or other substrate of the dressing in a uniform coating or patterned distribution to optimize breathability and conformability.

[0050] Suitable adhesive chemistries for securement dressings include acrylic-based pressuresensitive adhesives, silicone-based adhesives, and hydrocolloid adhesives, each offering distinct performance attributes. Acrylic adhesives are used due to their strong, durable bonds, resistance to moisture and environmental degradation, and tunable adhesion properties through polymer formulation and crosslinking. Silicone adhesives provide gentle yet consistent adhesion, making them particularly suitable for patients with fragile or compromised skin, such as neonates or elderly patients; they also allow atraumatic removal and repositioning without significant loss of tack. Hydrocolloid adhesives combine adhesion with moisture-absorbing capacity, creating a gel-like interface when in contact with wound exudate, which may be beneficial in certain securement applications involving minor exudation.

[0051] The first adhesive 120 layer may have a thickness in a range from 10 to 100 micrometers. The adhesive 120 layer may have a thickness in a range from 10 to 75 micrometers. The adhesive 120 layer may have a thickness in a range from 10 to 50 micrometer.

[0052] The second adhesive 125 layer may have a thickness in a range from 10 to 100 micrometers. The second adhesive 125 layer may have a thickness in a range from 10 to 75 micrometers. The second adhesive 125 layer may have a thickness in a range from 10 to 50 micrometer.

[0053] The third adhesive 160 layer may have a thickness in a range from 10 to 100 micrometers. The third adhesive 160 layer may have a thickness in a range from 10 to 75 micrometers. The third adhesive 160 layer may have a thickness in a range from 10 to 50 micrometer.

[0054] The support layer 150 in a medical securement dressing 100 functions as a structural component that enhances the mechanical stability, durability, and overall performance of the dressingPA200218W0002 during use. The support layer 150 may serve to distribute forces exerted on the attached medical article and a substrate surface such as skin, thereby reducing localized stress on the substrate or skin and minimizing motion at the insertion site. By reinforcing the dressing 100, the support layer 150 helps maintain the intended position of the dressing 100 and medial article over extended wear periods, even under conditions of patient movement, perspiration, or incidental contact. In some embodiments, the support layer 150 also assists in retaining the dressing’s overall shape during application, improving handling and placement accuracy.

[0055] The support layer 150 may be fabricated from materials that combine strength with flexibility, allowing the dressing 100 to conform to the patient’s body contours while resisting tearing or deformation. The support layer 150 may be formed of a material more rigid than the polymeric film 118. Suitable materials include woven or nonwoven polyester, nylon mesh, spunlace fabrics, or laminated composites incorporating polymeric films such as polyurethane or polyethylene terephthalate (PET). In certain designs, the support layer 150 may be partially or fully coated with a medical-grade adhesive to secure it to underlying dressing layers, or it may be embedded within the dressing laminate to form a unified composite structure as illustrated in FIG. 3.

[0056] In implementations, the notch length LI extends from a notch open end to a notch terminal end. The notch has a first width value W1 at the terminal end and a second width value W2 at the open end. The second width value W2 is greater than the first width value.

[0057] In other implementations, the notch length LI extends from a notch open end to a notch terminal end. The notch has a first width value W 1 at the terminal end and a second width value W2 at the open end. The second width value W2 is less than the first width value.

[0058] In other implementations, the notch length LI extends from a notch open end to a notch terminal end. The notch has a first width value W 1 at the terminal end and a second width value W2 at the open end. The second width value W2 is substantially equal to the first width value.

[0059] The reinforcement element 105 has a length value L2 that is parallel with the notch length LI and a width value W3 that is parallel with a notch width W2 or Wl. The reinforcement element 105 length value L2 is greater than the notch length value LI but less than four times the notch length value. ThePA200218W0002 reinforcement element 105 length value L2 is greater than the notch length value LI but may be less than three times the notch length value. The reinforcement element 105 length value L2 is greater than the notch length value LI but may be less than two times the notch length value.

[0060] The reinforcement element 105 has a length value L2 that is parallel with the notch length LI and a width value W3 that is parallel with a notch width W2 or W1. The reinforcement element width value W3 is greater than the notch width value W2 or W1 but less than five times the notch width value W2 or Wl. The reinforcement element width value W3 is greater than the notch width value W2 or W1 but may be less than four times the notch width value W2 or WL The reinforcement element width value W3 is greater than the notch width value W2 or Wl but may be less than three times the notch width value W2 or WL The reinforcement element width value W3 is greater than the notch width value W2 or Wl but may be less than two times the notch width value W2 or WL

[0061] The reinforcement element 105 may have a surface area value in a range from 1% to 40% of a surface area value of the backing 110. The reinforcement element 105 may have a surface area value in a range from 5% to 35% of a surface area value of the backing 110. The reinforcement element 105 may have a surface area value in a range from 10% to 20% of a surface area value of the backing 110.

[0062] The reinforcement element 105 may have a surface area value in a range from 10% to 90% of a surface area value of the support layer. The reinforcement element 105 may have a surface area value in a range from 10% to 75%, or from 20% to 50% of a surface area value of the support layer. The reinforcement element 105 may have a surface area value in a range from 20% to 40% of a surface area value of the support layer.

[0063] In many embodiments, the reinforcement element 105 is coextensive with the support layer 150. The entire surface area of the reinforcement element 105 may be within and overlapping the surface area of the support layer 150.

[0064] The reinforcement element 105 may have a notch that is co-extensive and coincident with the notch of the backing 110. The reinforcement element 105 may only be coincident with a portion of the backing outer perimeter 112.PA200218W0002

[0065] In the context of medical securement dressings, the term modulus refers to a measure of the stiffness of a material, typically expressed as the ratio of stress to strain under tensile loading. The modulus of a material influences how it responds to applied forces, including stretching, bending, and shear, and is therefore an important parameter in the design of securement dressings and their reinforcement elements. Materials with a relatively low modulus exhibit high flexibility and conformability, allowing the dressing to contour closely to a patient’s skin and accommodate body movement without lifting or discomfort. Conversely, materials with a high modulus provide greater structural rigidity and resistance to deformation, which can be advantageous for reinforcing portions of the dressing that are subject to concentrated loads or mechanical stress from an attached medical article.

[0066] As described above, the backing 110 layer may be formed from a low-to-moderate modulus polymeric film, such as polyurethane, to maintain breathability and conformability. By contrast, the reinforcement element 105 incorporated at the medical article exit feature may be formed from a higher modulus material, such as polyester film, polyethylene terephthalate (PET), nonwoven or a woven fabric composite, for example, to resist tearing and distribute mechanical loads. In some embodiments, the reinforcement element may be a laminate structure designed to provide a modulus substantially greater than that of the surrounding backing layer, thereby localizing stiffness only where needed while preserving overall dressing flexibility.

[0067] The modulus of materials suitable for use in medical securement dressings 100 can vary substantially depending on the intended function of the component. For example, polyurethane films commonly used as a backing 110 layer in transparent dressings may exhibit a tensile modulus in the range of about 0.5 to 5 MPa, measured according to ASTM D882 (Standard test Method for Tensile Properties of Thin Plastic Sheeting) or an equivalent tensile test standard. Such relatively low modulus values allow the film to remain thin, conformable, and highly flexible, thereby permitting the dressing to accommodate skin movement and to be worn comfortably for extended periods.

[0068] In contrast, materials used to form the reinforcement element 105 are selected to have a substantially higher modulus in order to provide localized structural stability and resistance to deformation under applied forces. For example, polyethylene terephthalate (PET) films may exhibit tensile modulus values in the range of about 1,500 to 3,000 MPa, while polyester fabrics or scrims may exhibit modulusPA200218W0002 values in the range of about 500 to 1,500 MPa, depending on weave density and treatment. Similarly, high- density polyethylene (HDPE) films or composite laminates can provide modulus values greater than about 800 MPa. In addition, low-density polyethylene (LDPE) films or composite laminates can provide modulus values greater than 10 MPa or from 150 to 300 MPa. These higher modulus materials, when positioned at force-bearing portions of the dressing, resist stretching, tearing, and creep, thereby distributing mechanical loads from a secured medical article over a broader area of the dressing.

[0069] By combining a low-modulus, conformable backing layer with a higher-modulus reinforcement element, the dressing 100 achieves an optimized balance between patient comfort and device stability. The lower modulus regions enable the dressing to flex with the skin and maintain adhesive contact, while the higher modulus reinforcement areas strengthen the dressing against dislodgement forces exerted by catheters, tubing, or other medical devices. This modulus differentiation ensures that the dressing performs effectively in its dual role as both a protective barrier and a securement device.

[0070] The reinforcement element 105 may have a modulus value that is at least 50% greater than a modulus value of the backing. The reinforcement element 105 may have a modulus value that is at least 150% greater than a modulus value of the backing. The reinforcement element 105 may have a modulus value that is at least 250% greater than, a modulus value of the backing. The reinforcement element 105 may have a modulus value that is at least 500% greater than, a modulus value of the backing.

[0071] In implementations, the reinforcement element 105 is formed of a low -density polyethylene film. The reinforcement element 105 is formed of a non-woven polyester layer.

[0072] The reinforcement element 105 may have a thickness in a range from 10 micrometers to 150 micrometers. The reinforcement element 105 may have a thickness from 25 micrometers to 130 micrometers. The reinforcement element 105 may have a thickness from 50 micrometers to 125 micrometers. The reinforcement element 105 may have a thickness from 75 micrometers to 110 micrometers.

[0073] The medical securement dressing 100 (without the carrier 130 or release liner 140) may be optically clear. The backing 110 and adhesive 120 may be optically clear. The backing 110 and adhesive 120 disposed within the carrier window 133 may be optically clear.PA200218W0002

[0074] Optical clarity and haze for medical securement dressings are generally determined using standardized optical test methods that measure how light passes through the material and how much it is scattered. These properties may assist the healthcare provider’s ability to visually inspect the insertion site without removing the dressing and also aid in accurate placement of the dressing.

[0075] Optical clarity is evaluated by measuring total luminous transmittance (TLT). The percentage of incident visible light that passes through the dressing material without significant absorption or scattering. A high TLT value indicates better optical clarity. This measurement is performed in accordance with ASTM D1003 (“Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics”) or equivalent ISO standards such as ISO 13468-1. In this method, a calibrated light source is directed at the sample, and a photodetector on the opposite side measures the amount of transmitted light. Optically clear medical dressing films may have TLT value or clarity value of at least 70%, or at least 75%, or at least 80%, or at least 85%, or at least 90%.

[0076] Haze is a measure of light scattering within the material that causes objects viewed through it to appear blurry or less distinct. Even if total light transmission is high, elevated haze values can reduce the sharpness of the image of the insertion site. ASTM DI 003 also provides the standard method for haze measurement, where haze is expressed as the percentage of transmitted light that deviates from the incident beam by more than 2.5° due to scattering. Lower haze percentages correspond to clearer visual inspection capability. The medical securement dressings may have a haze value of less than 40%, or less than 30%, or less than 20%, or less than 10%.

[0077] The moisture vapor transmission rate (MVTR) for a medical securement dressing may be determined using standardized test methods that quantify the rate at which water vapor passes through the dressing material under controlled conditions. MVTR is a parameter for dressings with adhesive films or composite layers, as it reflects the dressing’s ability to allow moisture from the skin surface to escape while still acting as a barrier to liquid water and contaminants. Adequate MVTR helps maintain skin integrity, reduces the risk of maceration, and contributes to patient comfort during extended wear. MVTR may be measured using the inverted cup method described in US 4,595,001.

[0078] The medical securement dressing preferably transmits moisture at least at the same rate or better than human skin. The medical securement dressing or backing and pressure sensitive adhesivePA200218W0002 transmit moisture vapor at a rate of at least 250 g / m2 / 24hrs / 37 degrees Celsius / 100-10% RH. The medical securement dressing or backing and pressure sensitive adhesive transmit moisture vapor at a rate of at least 350 g / m2 / 24hrs / 37 degrees Celsius / 100-10% RH. The medical securement dressing or backing and pressure sensitive adhesive transmit moisture vapor at a rate of at least 500 g / m2 / 24hrs / 37 degrees Celsius / 100-10% RH.

[0079] A carrier 130 may be referred to as a frame, handling film, or delivery liner, and is a temporary structural component of the medical securement dressing designed to facilitate accurate placement of the thin, flexible medical securement dressing 100 onto skin. Transparent film medical securement dressings may be made of a conformable polyurethane film, for example, that is thin and pliable, which can make them difficult to handle without stretching, wrinkling, or inadvertently adhering to itself during application. The carrier 130 provides mechanical stability to the medical securement dressing during handling, allowing the user to grasp, align, and apply the medical securement dressing precisely over the intended target site.

[0080] The carrier 130 may be constructed from a stiffer or more rigid material (such as polyethylene, polyester, or paper, for example) as compared to the thin conformable backing 110. The carrier 130 may be adhered to the backing top surface or polymeric film 118 via a light tack or removable adhesive or heat seal. This carrier 130 maintains the medical securement dressing’s 100 shape and prevents deformation as it is positioned. During application, the medical securement dressing 100 (with the carrier still attached) is placed against the skin, the adhesive 120 on the underside bonds to the skin surface, and then the carrier 130 is peeled away, leaving only the thin transparent medical securement dressing 100 in place. This process ensures that the thin transparent medical securement dressing 100 maintains proper tension and orientation during placement, producing a smooth, wrinkle-free seal that maximizes barrier and securement effectiveness.

[0081] The carrier 130 is defined by a carrier outer perimeter 131 and a carrier inner perimeter 132. The carrier inner perimeter 132 defines a carrier window 133. The carrier 130 is releasably bonded to the polymeric film 118. The carrier 130 is formed of a material more rigid than the polymeric film 118. A portion of the carrier inner perimeter 132 and a portion of the carrier outer perimeter 131 defines a carrier bridge element that extends from a first side of the polymeric film 118 to an opposing second side of thePA200218W0002 polymeric film 118. The carrier bridge element is disposed between the medical article exit feature 115 of the backing 110 and the carrier window 133. The carrier bridge element may include a slit 135.

[0082] The carrier 130 may be co-incident with only a portion of the backing 110 outer perimeter 112. The carrier 130 may be co-incident with the backing 110 outer perimeter 112 except for the backing 110 outer perimeter defining the medical article exit feature 115 of the backing 110.

[0083] The carrier 130 may not overlay the medical article exit feature 115. The carrier 130 may be spaced apart from the medical article exit feature 115. The carrier 130 may be co-incident with the medical article exit feature 115.

[0084] The outer perimeter 131 of the carrier bridge element may define a curved outer perimeter 131 from the first side of the polymeric film 118 to the opposing second side of the polymeric film 118. The outer perimeter 131 of the carrier bridge element may define a curved outer perimeter 131 from the first side of the polymeric film 118 to the opposing second side of the polymeric film 118 and the curved outer perimeter 131 of the carrier bridge element is spaced apart from the outer perimeter 112 of the medical article exit feature 115.

[0085] The backing 110 may include an insertion target indicia 114. The insertion target indicia 114 may be disposed within the carrier window 133. The insertion target indicia 114 may be indicia to align the medical securement dressing 100 onto the insertion site of the medical article entering the surface or skin.

[0086] A separate tape strip element 170 (see FIG. 3) may be attached to the carrier 130. The tape strip element 170 is configured to be applied by the clinician onto the medical article exit feature 115 to further secure the medical securement dressing 100 to the surface and optionally to the medical article to secure the medical article to the medical article exit feature 115. The tape strip element 170 may be adhered to a top surface of the carrier 130 prior to placement of the medical securement dressing 100 by the clinician. The carrier 130 may define an extension region spaced apart from the backing 110 of the medical securement dressing 100. The tape strip element 170 may be disposed on an opposing major surface to the major surface contacting the polymer film 118 prior to placement of the medical securement dressing 100 by the clinician.PA200218W0002

[0087] The tape strip element 170 includes a tape reinforcement element 106. The tape strip element 106 is defined by an outer perimeter 171. The tape strip element 170 includes a notch 175 extending into the tape strip element 170. The tape reinforcement element 106 is defined by an outer perimeter 107 partially co-incident with the outer perimeter 171 of the tape strip element.

[0088] The outer perimeter 107 of the reinforcing element 106 may be co-incident with the outer perimeter 171 of the tape strip element at the notch 175. The tape reinforcement element 106 may be coincident with only a portion of the tape strip element 170.

[0089] The reinforcing element 106 may be adhered to a support layer 151 with an adhesive 126 layer. A skin facing adhesive 161 layer may be disposed on the support layer 151. The support layer 151 may separate the adhesive 126 layer from the skin facing adhesive 161 layer. An optional release liner 141 may be disposed on the skin facing adhesive 161 layer.

[0090] FIG. 5, FIG. 6, and FIG. 7 illustrate a method of securing a medical article 200 to a surface. FIG. 5 is a schematic diagram top view of applying an illustrative medical securement dressing 100 onto a surface to secure a medical article 200 and deflecting the carrier 130. FIG. 6 is a schematic diagram top view of removing an illustrative carrier 130 from the polymer film or backing 110. FIG. 7 is a schematic diagram top view of an illustrative medical securement dressing 100 securing a medical article 200 to a surface.

[0091] FIG. 5 illustrates the clinician applying the pressure sensitive adhesive onto the medical article 200 and a surface to secure the medical article 200 to the surface. The medical article 200 extends through the medical article exit feature of the backing 110.

[0092] As the medical securement dressing is applied onto the medical article 200, the carrier 130 spreads apart and extend away from the polymeric film or backing 110. This allows the clinician to easily grasp and begin to remove the carrier 130 from the polymeric film or backing 110.

[0093] FIG. 5 illustrates the clinician removing the carrier 130 from the polymeric film or backing 110. The medical securement dressing secures the medical article 200 in place as illustrated in FIG. 6. APA200218W0002 tape strip element 170 may be placed at the medical article exit feature of the backing 110 to further secure the medical securement dressing in place.PA200218W0002

[0094] EXAMPLES

[0095] MATERIALS

[0096] Three commercially available medical dressings and an inventive example 1 were tested for peak axial pull force values (PAPF).

[0097] Commercial dressing 1 was a commercially available medical dressing available under the trade designation TEGADERM 1642W. This is a flat film substantially rectangular dressing composed of a polyurethane film and a skin-contacting adhesive.

[0098] Commercial dressings 2 and 3 were commercially available bordered polyurethane medical dressings available under the trade designation TEGADERM 1683 and TEGADERM 1882. These are composed of a polyurethane film and a skin-contacting adhesive, but they have an additional fabric / nonwoven layer that is adhered to the adhesive of the polyurethane film. The fabric / nonwoven layer additionally has its own layer of skin-contacting adhesive opposite the side laminated to the film. These dressings have a window shape cut into the fabric / nonwoven layer to allow visibility of the insertion site. These dressings also have a notch cut into them to facilitate a catheter / medical tube. Additionally, these dressings include (and were tested with) securement tape strips that were applied per their respective instructions for use (IFU).

[0099] Inventive Example 1 has the same construction as the Commercial dressings 2 and 3 with the addition of a reinforcing strip of material (4 mil LDPE) disposed between the skin-contacting adhesive of the polyurethane film and the nonwoven / fabric layer, surrounding the notch of the dressing, approximately one inch wide, and running from the bottom of the dressing to the bottom of the insertion site viewing window. A securement tape strip was also included with this dressing and was applied as is instructed in the IFU of the 1882.

[0100] TESTING

[0101] These dressings were used to secure a straight barrel PIV dressing and a standard extension set tubing to a steel plate. The steel plate was affixed to an imass (moving sled tester). The extension set was fixed to a force gauge. The sled was moved away from the force gauge in a direction substantially axialPA200218W0002 to the extension set tubing at a rate of 100 in / min. The maximum force was recorded (peak axial pull force) and reported.

[0102] RESULTS

[0103] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims.

Claims

PA200218W0002CLAIMS1. A medical securement dressing comprising: a backing defined by a backing outer perimeter, the backing having a first major surface and an opposing second major surface, a portion of the backing outer perimeter defines a medical article exit feature region of the backing, a polymeric film forms at least a portion of the first major surface, the medical article exit feature defines a notch extending into the backing a notch length value; a first pressure sensitive adhesive disposed on at least a portion of the second major surface; a reinforcement element disposed on only a portion of the first pressure sensitive adhesive, the reinforcement element defined by an outer perimeter co-incident with the medical article exit feature defining the notch, and the reinforcement element has a length value that is parallel with the notch length and a width value that is parallel with a notch width, and the reinforcement element width value is greater than the notch width value but less than five times the notch width value; a second pressure sensitive adhesive disposed on the reinforcement element; and a carrier defined by a carrier outer perimeter and a carrier inner perimeter, the carrier inner perimeter defining a carrier window, the carrier releasably bonded to the polymeric film, the carrier formed of a material more rigid than the polymeric film.

2. The medical securement dressing of claim 1, further comprising a release liner adhered to the first pressure sensitive adhesive and second pressure sensitive adhesive.

3. The medical securement dressing of claim 1, wherein the notch length extends from a notch open end to a notch terminal end, the notch has a first width value at the terminal end and a second width value at the open end, and the second width value is greater than the first width value.PA200218W00024. The medical securement dressing of claim 1, wherein the notch length extends from a notch open end to a notch terminal end, the notch has a first width value at the terminal end and a second width value at the open end, and the second width value is less than the first width value.

5. The medical securement dressing of claim 1, wherein the reinforcement element length value is greater than the notch length value but less than four times the notch length value.

6. The medical securement dressing of claim 1, wherein the reinforcement element width value is greater than the notch width value but less than four times the notch width value.

7. The medical securement dressing of claim 3, wherein the reinforcement element width value is greater than the second width value but less than four times the second width value.

8. The medical securement dressing of claim 4, wherein the reinforcement element width value is greater than the first width value but less than four times the first width value.

9. The medical securement dressing of claim 1, wherein the reinforcement element has a modulus value that is at least 50% greater than, or at least 150% greater than, or at least 250% greater than, a modulus value of the backing.

10. The medical securement dressing of claim 1, wherein the reinforcement element is formed of a nonwoven material.

11. The medical securement dressing of claim 1, wherein the carrier outer perimeter is co-incident with only a portion of the backing outer perimeter.

12. The medical securement dressing of claim 1, wherein the carrier outer perimeter is co-incident with the backing outer perimeter except for the medical article exit feature region of the backing.

13. The medical securement dressing of claim 1, wherein the backing comprises an insertion target indicia, the insertion target indicia is disposed within the carrier window.

14. The medical securement dressing of claim 1, wherein the backing comprises a support layer, the support layer formed of a material more rigid than the polymeric film.PA200218W000215. The medical securement dressing of claim 1, wherein the backing and first pressure sensitive adhesive is optically clear.

16. The medical securement dressing of claim 1, further comprising a tape strip element attached to the carrier.

17. The medical securement dressing of claim 16, wherein the tape strip element comprises a tape reinforcement element.

18. The medical securement dressing of claim 17, wherein the tape strip element is defined by an outer perimeter, the tape strip element comprising a notch extending into the tape strip element, the tape reinforcement element defined by an outer perimeter partially co-incident with the outer perimeter of the tape strip element.

19. The medical securement dressing of claim 1, wherein the backing and first pressure sensitive adhesive transmit moisture vapor at a rate of at least 250 g / m2 / 24hrs / 37 degrees Celsius / 100- 10% RH.

20. The medical securement dressing of claim 1, wherein the polymeric film has a thickness in a range from 15 micrometers to 50 micrometers, or from 20 micrometers to 40 micrometers.

21. The medical securement dressing of claim 1, wherein the reinforcement element has a thickness in a range from 10 micrometers to 150 micrometers, or from 25 micrometers to 130 micrometers, or 50 micrometers to 125 micrometers, or from 75 micrometers to 110 micrometers.

22. The medical securement dressing of claim 1, wherein the reinforcement element has a surface area value in a range from 1% to 40%, or from 5% to 35%, or from 10% to 20% of a surface area value of the backing.

23. The medical securement dressing of claim 14, wherein the reinforcement element has a surface area value in a range from 10% to 90%, or from 10% to 75%, or from 20% to 50%, or from 20% to 40% of a surface area value of the support layer.PA200218W000224. The medical securement dressing of claim 23, wherein the reinforcement element is coextensive with the support layer.

Images