Medical sensor securement dressing

Abstract

A medical sensor securement dressing includes a backing defined by a backing outer perimeter and a backing inner perimeter. The backing inner perimeter defines an open aperture. The backing having a first major surface and an opposing second major surface. A polymeric film forms the first major surface. A pressure sensitive adhesive is disposed on at least a portion of the second major surface. A release liner is adhered to the pressure sensitive adhesive. 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.

Description

PA200114W002MEDICAL SENSOR SECUREMENT DRESSINGFIELD OF INVENTION

[0001] The present disclosure relates to medical dressings, and more particularly to a medical sensor securement dressing that includes a carrier that applies minimal force to the secured medical article when removed.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, medical sensors, 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] 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.

[0004] 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. 5,088,483discloses 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.).

[0005] Applying the medical securement dressing to a patient may transmit forces to the medical device or medical sensor inserted into the skin of the patient and cause discomfort to the patient. In addition, removal of the carrier from the applied medical securement dressing may be challenging and cause discomfort to the patient or disruption of the dressing adhesive bond to the patient’s skin when the clinician attempts to grasp an edge of the carrier to remove the carrier from the medical securement dressing.SUMMARY

[0006] The present disclosure relates to medical dressings, and more particularly to a medical sensor securement dressings that include a carrier that applies minimal force to the secured medical sensor when removed. The medical sensor securement dressings defines an open aperture that mates with the medical sensor being secured to the surface.

[0007] The medical sensor securement dressings that include a carrier and a backing defining an open aperture. The carrier may include a tab portion that is partially defined by a slit that extends from an inner perimeter to an outer perimeter of the carrier.

[0008] The medical sensor securement dressings described herein have a void space defined within the medical sensor securement dressing that may act as a tactile alignment tool for the user applying the medical sensor securement dressing. Advantageously the medical sensor securement dressing may be applied with only a single hand by the user.

[0009] According to an aspect of the present disclosure, a medical sensor securement dressing includes a backing defined by a backing outer perimeter and a backing inner perimeter. The backing inner perimeter defines an open aperture. The backing having a first major surface and an opposing second major surface. A polymeric film forms the first major surface. A pressure sensitive adhesive is disposed on at least a portion of the second major surface. A release liner is adhered to the pressure sensitive adhesive. A carrier is defined by a carrier outer perimeter and a carrier inner perimeter. Thecarrier 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.

[0010] In implementations, the backing inner perimeter is co-incident with the carrier inner perimeter. The carrier may include a slit extending from the carrier inner perimeter to the carrier outer perimeter.

[0011] The carrier may include a tab portion extending away from a distance from the backing outer perimeter. This allows the user to easily grasp the carrier for removal from the backing.

[0012] The tab portion may be configured to form a peel front that is tangential to the open aperture as the carrier is removed from the polymeric film. This reduces forces on the backing layer and mitigates lifting of the backing from the surface during removal of the carrier from the backing.

[0013] The backing may have a thickness in a range from 15 micrometers to 50 micrometers, or from 20 micrometers to 40 micrometers. The backing may be optically clear and transmit moisture vapor at a rate of at least 250 g / m2 / 24hrs / 37 degrees Celsius / 100- 10% RH.

[0014] According to another aspect of the present disclosure, a method of securing a medical sensor to a surface comprises removing a release liner from a medical sensor securement dressing, applying the pressure sensitive adhesive around the medical sensor and onto a surface to secure the medical sensor to the surface, and removing the carrier from the polymeric film by pulling the tab away from the polymeric film. The medical sensor extends through the open aperture of the backing. The medical securement dressing includes a backing defined by a backing outer perimeter and a backing inner perimeter. The backing inner perimeter defining an open aperture. The backing having a first major surface and an opposing second major surface. A polymeric film forms the first major surface. A pressure sensitive adhesive is disposed on at least a portion of the second major surface. A release liner is adhered to the pressure sensitive adhesive. 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. The carrier comprises a slit extending from the carrier inner perimeter to the carrier outer perimeter. The slit partially defining a tab element extending away from the outer perimeter of the backing.

[0015] 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

[0016] Non-limiting and non-exhaustive examples are described with reference to the following figures.

[0017] FIG. 1A is a schematic diagram top view of an illustrative medical sensor securement dressing.

[0018] FIG. IB is a schematic diagram exploded perspective view of the illustrative medical sensor securement dressing of FIG. 1A.

[0019] FIG. 2A is a schematic diagram top view of another illustrative medical sensor securement dressing.

[0020] FIG. 2B is a schematic diagram exploded perspective view of the illustrative medical sensor securement dressing of FIG. 1A.

[0021] FIG. 3 is a schematic diagram top view of a sensor secured by an illustrative medical sensor securement dressing.

[0022] FIG. 4 is a flow diagram of a method of securing a medical sensor 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.

[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 a medical sensor securement dressings that include a carrier that applies minimal force to the secured medicalsensor when removed. The medical sensor securement dressings defines an open aperture that mates with the medical sensor being secured to the surface.

[0034] The medical sensor securement dressings that include a carrier and a backing defining an open aperture. The carrier may include a tab portion that is partially defined by a slit that extends from an inner perimeter to an outer perimeter of the carrier.

[0035] The medical sensor securement dressings described herein have a void space defined within the medical sensor securement dressing that may act as a tactile alignment tool for the user applying the medical sensor securement dressing. Advantageously the medical sensor securement dressing may be applied with only a single hand by the user.

[0036] A medical securement dressing for a sensor, such as a continuous glucose monitor (CGM), for example, is configured to stabilize a subdermal sensor module and its external transmitter housing against skin while preserving breathability and comfort over multi-day wear. The medical sensor securement dressing includes a conformable backing layer, a skin-contact adhesive layer, and an optional reinforcement element disposed to surround, but not occlude, the sensor housing. The medical sensor securement dressing defines a central window or recess sized to receive the sensor housing so that the device contacts the patient’s skin through the window, while a surrounding adhesive backing “skirt” anchors the sensor periphery and resists edge lift caused by perspiration, clothing friction, and athletic activity. The medical sensor securement dressing may be supplied sterile, individually pouched, and configured for one-handed application.

[0037] FIG. 1A is a schematic diagram top view of an illustrative medical sensor securement dressing 100. FIG. IB is a schematic diagram exploded perspective view of the illustrative medical sensor securement dressing 100 of FIG. 1A. FIG. 2A is a schematic diagram top view of another illustrative medical sensor securement dressing 200. FIG. 2B is a schematic diagram exploded perspective view of the illustrative medical sensor securement dressing 200 of FIG. 2A.

[0038] According to an aspect of the present disclosure, a medical sensor securement dressing 100, 200 includes a backing 110, 210 defined by abacking outer perimeter 112, 212 and abacking inner perimeter 114, 214. The backing inner perimeter 114, 214 defines an open aperture 115, 215. The backing 110, 210 has a first major surface 111, 211 and an opposing second major surface 113, 213. A polymeric film 118, 218 forms the first major surface 111, 211. A pressure sensitive adhesive 120, 220 is disposed on at least a portion of the second major surface 113, 213. A release liner 140, 240 is adheredto the pressure sensitive adhesive 120, 220. A carrier 130, 230 is defined by a carrier outer perimeter 131, 231 and a carrier inner perimeter 132, 232. The carrier inner perimeter 132, 232 defining a carrier window 133, 233. The carrier 130, 230 is releasably bonded to the polymeric film 118, 218. The carrier 130, 230 is formed of a material more rigid than the polymeric film.

[0039] FIG. 2A and FIG. 2B illustrate another implantation where the carrier 230 a further includes an inner window 234. This inner window 234 is defined by an outer frame element 237 and an inner frame element 238. The inner frame element 238 is defined by the carrier inner perimeter 232 and an inner frame element outer perimeter 239. The outer frame element 237 is defined by the carrier outer perimeter 231 and an outer frame element inner perimeter 241. The inner frame element 238 is spaced apart from the outer frame element 237.[O040] In many embodiments, the polymeric film 118, 218 forms the outer surface of the medical sensor securement dressing 100, 200 once the carrier 130, 230 is removed. The medical sensor securement dressing 100, 200 has a polymeric film 118, 218 outer surface that provides advantages such as allowing easy wipe down of the surface and medical sensor securement dressing 100, 200 by the medical professional to ensure sterility.

[0041] The release liner 140, 240 is provided on the adhesive 120, 220 layer forming the bottom layer of the medical sensor securement dressing 100, 200. Release liners 140, 240 may be included that covers all or a portion of the adhesive 120, 220 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 liner may be paper, polyolefin film, or polyester film coated with silicone release materials.

[0042] The backing 110, 210 of the medical sensor securement dressing 100, 200 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, 210 is formed from a conformable, waterproof, and moisture-vapor-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 or subdermal insertion site of the indwelling medical sensor, such as a continuous glucose monitor, 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.

[0043] Suitable materials for the backing 110, 210 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 area about the secured medical sensor, while in others it may be opaque to provide privacy or to shield the site from light exposure.

[0044] The backing 110, 210 or polymeric film 118, 218 may have a thickness in a range from 15 to 100 micrometers. The backing 110, 210 or polymeric film 118, 218 may have a thickness in a range from 15 to 50 micrometers. The backing 110, 210 or polymeric film 118, 218 may have a thickness in a range from 20 to 40 micrometers.

[0045] A pressure sensitive adhesive 120, 220 is disposed on at least a portion of the second major surface 113, 213. The pressure sensitive adhesive 120, 220 may adhere the medical sensor securement dressing 100, 200 to a surface and the medical sensor. A release liner may be disposed on or adhered to the pressure sensitive adhesive 120, 220.

[0046] Adhesive or pressure sensitive adhesive materials used in medical sensor securement dressings are selected to provide reliable fixation of the dressing to the medical senor and 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.

[0047] 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 alsoallow 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.

[0048] The adhesive 120, 220 layer may have a thickness in a range from 10 to 100 micrometers. The adhesive 120, 220 layer may have a thickness in a range from 10 to 75 micrometers. The adhesive 120, 220 layer may have a thickness in a range from 10 to 50 micrometer.

[0049] The medical sensor securement dressing 100, 200 (without the carrier 130, 230 or release liner 140, 240) may be optically clear. The backing 110, 210 and adhesive 120, 220 may be optically clear.

[0050] Optical clarity and haze for medical sensor 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.

[0051] 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 DI 003 (“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%.

[0052] 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%.

[0053] The moisture vapor transmission rate (MVTR) for a medical sensor securement dressing may be determined using standardized test methods that quantify the rate at which water vapor passesthrough the dressing material under controlled conditions. MVTR is a parameter for dressings with adhesive fdms 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.

[0054] The medical sensor securement dressing preferably transmits moisture at least at the same rate or better than human skin. The medical sensor securement dressing or backing and pressure sensitive adhesive transmit moisture vapor at a rate of at least 250 g / m2 / 24hrs / 37 degrees Celsius / 100- 10% RH. The medical sensor 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 sensor 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.

[0055] A carrier 130, 230 may be referred to as a frame, handling fdm, or delivery liner, and is a temporary structural component of the medical sensor securement dressing designed to facilitate accurate placement of the thin, flexible medical securement dressing 100, 200 onto skin and the medical sensor. Transparent fdm medical sensor securement dressings may be made of a conformable polyurethane fdm, 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, 230 provides mechanical stability to the medical sensor securement dressing during handling, allowing the user to grasp, align, and apply the medical sensor securement dressing precisely over the intended target site.

[0056] The carrier 130, 230 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, 210. The carrier 130, 230 may be adhered to the backing top surface or polymeric fdm 118, 218 via a light tack or removable adhesive or heat seal. This carrier 130, 230 maintains the medical sensor securement dressing’s 100, 200 shape and prevents deformation as it is positioned. During application, the medical sensor securement dressing 100, 200 (with the carrier still attached) is placed against the skin, the adhesive 120, 220 on the underside bonds to the skin surface and the medical sensor, and then the carrier 130, 230 is peeled away, leaving only the thin transparent medical sensor securement dressing 100, 200 in place. This process ensures that the thin transparent medical sensor securement dressing 100, 200maintains proper tension and orientation during placement, producing a smooth, wrinkle -free seal that maximizes barrier and securement effectiveness.

[0057] The carrier 130, 230 is defined by a carrier outer perimeter 131, 231 and a carrier inner perimeter 132, 232. The carrier inner perimeter 132, 232 defines a carrier window 133, 233. The carrier 130, 230 is releasably bonded to the polymeric film 118, 218. The carrier 130, 230 is formed of a material more rigid than the polymeric film 118, 218. The carrier window 133, 233 is sized and configured to receive the housing of the medical sensor.

[0058] The carrier 130, 230 inner perimeter 132, 232 may be co-incident with the backing 110, 210 inner perimeter 114, 214. The carrier 130, 230 inner perimeter 132, 232 may be co-extensive with the backing 110, 210 inner perimeter 114, 214. The carrier 130, 230 inner perimeter 132, 232 may be co-incident with and coextensive with the backing 110, 210 inner perimeter 114, 214. The backing 110, 210 inner perimeter 114, 214 is sized and configured to receive the housing of the medical sensor.

[0059] The carrier 130, 230 preferably includes a slit, cut, or line of weakness 135, 235. The slit, cut, or line of weakness 135, 235 may extends from the carrier outer perimeter 131, 231 to the carrier inner perimeter 132, 232. The slit, cut, or line of weakness 135, 235 may define a curved shape from the carrier outer perimeter 131, 231 to the carrier inner perimeter 132, 232. The slit, cut, or line of weakness 135, 235 aids in the removal of the carrier 130, 230 from the polymeric film 118, 218.

[0060] The carrier 130, 230 may include a tab portion 136 extending a distance away from the backing 110, 210 outer perimeter 114, 214. The tab portion 136, 236 aids in the removal of the carrier 130, 230 from the polymeric film 118, 218. The tab portion 136, 236 may be partially defined by the slit, cut, or line of weakness 135, 235.

[0061] The tab portion 136, 236 may be configured to form a peel front (during removal of the carrier 130, 230 from the polymeric film 118, 218) that is tangential to the open aperture 115, 215 as the carrier 130, 230 is removed from the polymeric film 118, 218. This tangential peel front may evenly distribute the peel forces along an entire width of the backing 110, 210 from the open aperture 115, 215 to the backing 110, 210 outer perimeter 112, 212 and minimizing uplift or removal of the adhesive from the surface or the medical sensor during removal of the carrier 130, 230 from the polymeric film 118, 218. This peel front may propagate around the backing in a clockwise or counter-clockwise motion as the carrier 130, 230 is removed from the polymeric film 118, 218.

[0062] The backing 110, 210 open aperture 115, 215 and the carrier window 133, 233 may have a substantially identical shape. The backing 110, 210 open aperture 115, 215 may define a circular shape. The carrier window 133, 233 may define a circular shape. The backing 110, 210 open aperture 115, 215 may define a rounded-rectangular shape. The carrier window 133, 233 may define a rounded- rectangular shape. The backing 110, 210 open aperture 115, 215 may define an oblong shape. The carrier window 133, 233 may define an oblong shape.

[0063] The release liner 140, 240 may define an open aperture 145, 245. The open aperture 145, 245 may have a substantially identical shape as the backing 110, 210 open aperture 115, 215 and the carrier window 133, 233. The release liner 140, 240 open aperture 145, 245 may be co-incident with one or both of the backing 110, 210 open aperture 115, 215 and the carrier window 133, 233. The release liner 140, 240 open aperture 145, 245 may be co-incident with and co-extensive with one or both of the backing 110, 210 open aperture 115, 215 and the carrier window 133, 233.

[0064] In some embodiments the backing 110, 210 further includes a support layer (not shown). The support layer may form a layer within the backing 110, 210 and attached to the polymeric film 118, 218 via an adhesive.

[0065] The support layer in a medical sensor securement dressing 100, 200 functions as a structural component that enhances the mechanical stability, durability, and overall performance of the dressing during use. The support layer may serve to distribute forces exerted on the secured medical sensor and a substrate surface such as skin, thereby reducing localized stress on the substrate or skin and minimizing motion at the medical sensor subdermal insertion site. By reinforcing the dressing 100, 200, the support layer helps maintain the intended position of the dressing 100, 200 and medial sensor over extended wear periods, even under conditions of patient movement, perspiration, or incidental contact. In some embodiments, the support layer also assists in retaining the dressing’s overall shape during application, improving handling and placement accuracy.

[0066] The support layer may be fabricated from materials that combine strength with flexibility, allowing the dressing 100, 200 to conform to the patient’s body contours while resisting tearing or deformation. The support layer may be formed of a material more rigid than the polymeric film 118, 218. 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 may be partially or fully coated with a medical-gradeadhesive to secure it to underlying dressing layers, or it may be embedded within the dressing laminate to form a unified composite structure.

[0067] FIG. 3 is a schematic diagram top view of a sensor 150 secured by an illustrative medical sensor securement dressing 100. The illustrative medical sensor securement dressing 100 is shown optically transparent. The medical sensor 150 is shown with a skirt 155 fixed to and extending away from the medical sensor 150 housing.

[0068] The medical sensor securement dressing 100 overlays the medical sensor 150 skirt 155 and fixes the medical sensor 150 to the surface 160, such as skin of a patient. The medical sensor 150 housing is received within the backing open aperture.

[0069] FIG. 4 is a flow diagram of a method 300 of securing a medical sensor to a surface. The method 300 of securing a medical sensor to a surface includes removing a release liner from a medical sensor securement dressing (at step 301), applying the pressure sensitive adhesive around the medical sensor and onto a surface to secure the medical sensor to the surface (at step 302), and removing the carrier from the polymeric film by pulling the tab away from the polymeric film (at step 303). The medical sensor extends through the open aperture of the backing. The medical securement dressing includes a backing defined by a backing outer perimeter and a backing inner perimeter. The backing inner perimeter defining an open aperture. The backing having a first major surface and an opposing second major surface. A polymeric film forms the first major surface. A pressure sensitive adhesive is disposed on at least a portion of the second major surface. A release liner is adhered to the pressure sensitive adhesive. 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. The carrier comprises a slit extending from the carrier inner perimeter to the carrier outer perimeter. The slit partially defining a tab element extending away from the outer perimeter of the backing.

[0070] The removing step 303 may include pulling the tab away from the polymeric film and forming a peel front that is tangential to the backing inner perimeter. In man y implementations, the open aperture and the carrier window are co -incident and form a circular opening or a rounded- rectangular shape through the medical sensor securement dressing. The medical sensor may defines a circular shape or a rounded-rectangular shape configured to mate with the circular opening or a rounded- rectangular opening through the medical sensor securement dressing.

[0071] 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

CLAIMS1. A medical sensor securement dressing comprising: a backing defined by a backing outer perimeter and a backing inner perimeter, the backing inner perimeter defining an open aperture, the backing having a first major surface and an opposing second major surface, a polymeric film forms the first major surface; a pressure sensitive adhesive disposed on at least a portion of the second major surface; a release liner adhered to the pressure sensitive adhesive; 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 sensor securement dressing of claim 1, wherein the backing inner perimeter is coincident with the carrier inner perimeter.

3. The medical sensor securement dressing of claim 1, wherein the carrier comprises a slit extending from the carrier inner perimeter to the carrier outer perimeter.

4. The medical sensor securement dressing of claim 3, wherein the slit defines a curved shape.

5. The medical sensor securement dressing of claim 1, wherein the carrier comprises a tab portion extending a distance away from the backing outer perimeter.

6. The medical sensor securement dressing of claim 3, wherein the carrier comprises a tab portion extending a distance away from the backing outer perimeter and the slit defines a portion of the tab portion.

7. The medical sensor securement dressing of claim 6, wherein the tab portion is configured to form a peel front that is tangential to the open aperture as the carrier is removed from the polymeric film.

8. The medical sensor securement dressing of claim 1, wherein the open aperture defines a circular shape.

9. The medical sensor securement dressing of claim 8, wherein the carrier window defines a circular shape.

10. The medical sensor securement dressing of claim 9, wherein open aperture and the carrier window are co-incident and form an opening through the medical sensor securement dressing.

11. The medical sensor securement dressing of claim 1, wherein the release liner defines an open aperture co-incident with the backing inner perimeter.

12. The medical sensor securement dressing of claim 1, wherein the carrier further defines an inner window defined by an outer frame element and an inner frame element, the inner frame element defined by the carrier inner perimeter and an inner frame element outer perimeter, the outer frame element defined by the carrier outer perimeter and an outer frame element inner perimeter, the inner frame element is spaced apart from the outer frame element.

13. The medical sensor 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.

14. The medical securement dressing of claim 1, wherein the backing and pressure sensitive adhesive is optically clear.

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

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

17. A method of securing a medical sensor to a surface comprising: removing a release liner from a medical sensor securement dressing, the medical securement dressing comprising: a backing defined by a backing outer perimeter and a backing inner perimeter, the backing inner perimeter defining an open aperture, the backing having a firstmajor surface and an opposing second major surface, a polymeric fdm forms the first major surface; a pressure sensitive adhesive disposed on at least a portion of the second major surface; a release liner adhered to the pressure sensitive adhesive; 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, the carrier comprises a slit extending from the carrier inner perimeter to the carrier outer perimeter, the slit partially defining a tab element extending away from the outer perimeter of the backing; applying the pressure sensitive adhesive around the medical sensor and onto a surface to secure the medical sensor to the surface and the medical sensor extends through the open aperture of the backing; and removing the carrier from the polymeric film by pulling the tab away from the polymeric film.

18. The method according to claim 17, wherein the removing comprises pulling the tab away from the polymeric film and forming a peel front that is tangential to the backing inner perimeter.

19. method according to claim 17, wherein the open aperture and the carrier window are co-incident and form a circular opening through the medical sensor securement dressing, and the medical sensor defines a circular shape configured to mate with the circular opening through the medical sensor securement dressing.

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