Skin patch anti-gravity system

Abstract

A system for deploying a physiological property sensor with a sensor inserter includes an adhesive skin patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system also includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially parallel to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

Description

TECHNICAL FIELD

[0001] Embodiments of the subject matter described herein relate generally to medical devices, such as a skin patch for a physiological property sensor assembly. More particularly, embodiments of the subject matter relate to improving the resistance to gravity of a skin patch during storage to ensure that the skin patch remains ready for coupling to a user after a period of time. BACKGROUND

[0002] Various medical conditions can be treated or monitored using sensors. In one example, a thin film electrochemical sensor is used to test a patient or user for analyte levels. More particularly, thin film sensors have been designed for obtaining an indication of blood glucose (BG) levels of a diabetic user and monitoring the BG levels, with a distal segment of the sensor positioned subcutaneously in direct contact with extracellular fluid. Such readings can be particularly useful in adjusting a treatment regimen that typically includes periodic administration of insulin to the user.

[0003] Glucose sensors of the type described above can be packaged and sold as products, such as continuous glucose monitors, which are adhered to a patient during use by an adhesive skin patch. In some cases, the continuous glucose monitor can be packaged with a sensor introducer tool, which enables the glucose sensor to be implanted subcutaneously / transcutaneously. The sensor introducer tool includes a needle for piercing the skin of a user while the sensor is introduced. The needle is then withdrawn, leaving the sensor in the skin of the user.

[0004] In cases where a continuous glucose sensor is packaged with a sensor introducer tool, the continuous glucose sensor can be positioned within the sensor introducer tool such that the skin patch is subject to gravity. When gravity acts on the skin patch, it can cause the skin patch to sag or sink within the sensor introducer tool. When this occurs, the skin patch, particularly its peripheral regions, will no longer be positioned perpendicular to the longitudinal axis of the introducer tool. When the skin patch sags or sinks within the sensor introducer tool, the skin patch can fold upon itself and, thus, can not adhere well to the user when the tool is actuated.

[0005] Accordingly, it would be desirable to provide a system for improving the resistance to gravity of a skin patch, such as a skin patch coupled to a physiological property sensor (e.g., a glucose sensor or a continuous glucose monitor), that inhibits the skin patch from sagging or sinking to ensure that the skin patch remains ready for coupling to a user after a period of time. Moreover, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background. SUMMARY

[0006] The technology of the present disclosure relates generally to systems that improve the anti-gravity of adhesive skin patches, such as adhesive skin patches coupled to medical devices, such as glucose sensors or continuous glucose monitors.

[0007] A system for deploying a physiological property sensor with a sensor inserter is provided in accordance with various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system further includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

[0008] A system for deploying a physiological property sensor with a sensor inserter is provided in accordance with various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system further includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

[0009] A system for deploying a physiological property sensor with a sensor inserter is provided in accordance with various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system further includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

[0010] A system for deploying a physiological property sensor with a sensor inserter is also provided in accordance with various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor, and the anti-gravity system is removable from the sensor inserter by the adhesive patch upon deployment of the physiological property sensor.

[0011] A system for deploying a physiological property sensor with a sensor inserter is also provided in accordance with various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. The adhesive patch couples the physiological property sensor to an anatomical structure. The system includes an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter. The anti-gravity system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor, and the anti-gravity system is removable from the sensor inserter by the adhesive patch upon deployment of the physiological property sensor.

[0012] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the DETAILED DESCRIPTION. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. Details of one or more aspects of the disclosure are described in the DETAILED DESCRIPTION, the DRAWINGS, and the CLAIMS. BRIEF DESCRIPTION OF DRAWINGS

[0013] A more complete understanding of the subject matter can be obtained by referring to the following detailed description and the attached drawings, in which like reference numerals refer to like elements in the several figures.

[0014] Figure 1 is a perspective view of an exemplary sensor introduction system including a sensor inserter and a physiological property sensor assembly having an exemplary anti-gravity system in accordance with the various teachings of the present disclosure;

[0015] Figure 2 is a cross-sectional view of the sensor introduction system of Figure 1 taken along line 2-2 of Figure 1 ;

[0016] Figure 3 It includes Figure 1 A top view of the physiological characteristic sensor assembly of an exemplary antigravity system;

[0017] Figure 4 It includes Figure 1 Side view of the physiological characteristic sensor assembly of an exemplary antigravity system;

[0018] Figure 5 From Figure 1 The perspective view of line 2-2 is a cross-sectional view of another exemplary sensor introduction system, which, in accordance with the various teachings of this disclosure, includes a sensor inserter and a sensor assembly with physiological characteristics of an exemplary antigravity system.

[0019] Figure 6 It includes Figure 5 A top view of the physiological characteristic sensor assembly of an exemplary antigravity system;

[0020] Figure 7 It includes Figure 6 The physiological characteristic sensor assembly of the exemplary antigravity system along Figure 6 The sectional view taken from line 7-7;

[0021] Figure 8 It includes Figure 5 A bottom view of the physiological characteristic sensor assembly of an exemplary antigravity system, wherein the adhesive patch associated with the physiological characteristic sensor assembly has been removed for clarity.

[0022] Figure 9 From Figure 1 The perspective view of line 2-2 is a cross-sectional view of another exemplary sensor introduction system, which, in accordance with the various teachings of this disclosure, includes a sensor inserter and a sensor assembly with physiological characteristics of an exemplary antigravity system.

[0023] Figure 10 It includes Figure 9 A top view of the physiological characteristic sensor assembly of an exemplary antigravity system;

[0024] Figure 11 It includes Figure 10 The physiological characteristic sensor assembly of the exemplary antigravity system along Figure 10 A sectional view taken from line 11-11;

[0025] Figure 12 From Figure 1The perspective view of line 2-2 is a cross-sectional view of another exemplary sensor introduction system, which, in accordance with the various teachings of this disclosure, includes a sensor inserter and a sensor assembly with physiological characteristics of an exemplary antigravity system.

[0026] Figure 13 It includes Figure 12 A top view of the physiological characteristic sensor assembly of an exemplary antigravity system;

[0027] Figure 14 It includes Figure 13 The physiological characteristic sensor assembly of the exemplary antigravity system along Figure 13 The sectional view taken by line 14-14; and

[0028] Figure 15 From Figure 1 The perspective view of line 2-2 is a cross-sectional view of another exemplary sensor introduction system, which, in accordance with the various teachings of this disclosure, includes a sensor inserter and a sensor assembly with physiological characteristics of an exemplary antigravity system. Detailed Implementation

[0029] The following detailed descriptions are illustrative in nature only and are not intended to limit the subject matter or the application and use of such embodiments. As used herein, the word "exemplary" means "serving as an example, illustration, or description." Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, it is not intended to be bound by any express or implied theory present in the foregoing technical field, background art, utility model content, or the following detailed descriptions.

[0030] Certain terms may be used in the following description for reference only and are therefore not intended to be limiting. Terms such as “front,” “rear,” “rear,” “side,” “outer,” and “inner” may be used to describe the orientation and / or position of parts of a component within a consistent but arbitrary frame of reference, as clearly illustrated by the text of the component discussed in the reference description and the accompanying drawings. Such terms may include words specifically mentioned above, their derivatives, and words with similar meanings. Similarly, unless explicitly indicated by the context, the terms “first,” “second,” and other such numerical terms referring to structures do not imply order or sequence.

[0031] As used herein, the term "axial" refers to a direction generally parallel to, or coincident with, a rotational axis, a symmetry axis, or a centerline of one or more components. For example, in a cylinder or a disc having a centerline and generally circular ends or opposing faces, an "axial" direction can refer to a direction extending generally parallel to the centerline between the opposing ends or faces. In certain instances, the term "axial" can be used with respect to components that are not cylindrical (or otherwise radially symmetric). For example, an "axial" direction for a rectangular housing containing a rotational shaft can be considered to be a direction generally parallel to, or coincident with, the rotational axis of the shaft. Also, as used herein, the term "radial" can refer to a direction or relationship of components relative to a common centerline, axis, or similar reference, e.g., a line extending outward in a plane perpendicular to the centerline or axis of a cylinder or disc. In certain instances, components can be considered to be "radially" aligned even if one or both of the components can not be cylindrical (or otherwise radially symmetric). Also, the terms "axial" and "radial" (and any derivatives thereof) can encompass a directional relationship that is not precisely aligned (e.g., tilted) with the true axial and radial dimensions, provided that the relationship is primarily in the corresponding nominal axial or radial direction. As used herein, the term "tilted" means an axis that intersects another axis at an angle such that the axis and the other axis are neither substantially perpendicular nor substantially parallel.

[0032] The following description relates to various embodiments for an adhesive skin patch anti-gravity system. For example, the systems described herein inhibit or mitigate the effects of gravity on an adhesive skin patch during storage, which ensures proper adhesion of the skin patch to a user. It should be noted that while the adhesive skin patches described herein are used with glucose sensors, such as glucose sensors associated with continuous glucose monitors, it should be understood that the adhesive skin patches can be used with a variety of other sensors (e.g., heart monitors, body temperature sensors, EKG monitors, etc.), medical devices, and / or other components intended to be attached to a user's body. Thus, while the non-limiting examples described below relate to a medical device for treating diabetes (more specifically, an adhesive skin patch coupled to a continuous glucose monitor), embodiments of the disclosed subject matter are not limited thereto.

[0033] Generally, the glucose sensor used with the adhesive patch is a continuous glucose sensor of the type used by diabetic users. For the sake of brevity, conventional aspects and techniques related to glucose sensors and glucose sensor manufacturing can not be described in detail herein. In this regard, known and / or conventional aspects of glucose sensors and their manufacture can be, but are not limited to, the types described in U.S. Patent Nos. 6,892,085; 7,468,033; and 9,295,786; and U.S. Patent Application No. 2009 / 0299301 (each of which is incorporated herein by reference).

[0034] Reference is made to Figure 1 , Figure 1 Perspective view of a sensor introduction assembly 100. In one example, the sensor introduction assembly 100 includes a physiological property sensor assembly 102 and a sensor inserter 104. It should be noted that in certain embodiments, the sensor inserter 104 and the physiological property sensor 108 can comprise the insertion device and sensor launcher assembly described in commonly assigned U.S. Patent Publication No. 2017 / 0290533 to Antonio et al., relevant portions of which are incorporated herein by reference. In this example, additional reference is made to Figure 2 The physiological property sensor assembly 102 includes a physiological property sensor 108, an adhesive skin patch or adhesive patch 110, and an anti-gravity system 112. Generally, the components of the physiological property sensor assembly 102 are coupled together as a single unit. The physiological property sensor assembly 102 and the sensor inserter 104 can be packaged together for use by a consumer.

[0035] Certain features, aspects, and characteristics of the sensor inserter 104, the physiological property sensor 108, and the adhesive patch 110 can be conventional and, as such, will not be described in detail herein. Briefly, the physiological property sensor 108 can be pre-connected as part of a sensor set that can also include a sensor electronics module (not shown), e.g., a wireless transmitter that communicates with an infusion pump, a monitor device, etc., that connects to the physiological property sensor 108 after partial insertion or deployment of the physiological property sensor 108 in the user's body. In one example, the physiological property sensor 108 includes a glucose sensor 122 and a sensor hub 124. It should be noted that the physiological property sensor 108 is not limited to a glucose sensor, but rather, various other physiological property sensors can be employed. The glucose sensor 122 can be provided as an integral part of the sensor hub 124. The sensor hub 124 gives structural support to the glucose sensor 122 and facilitates entry of the glucose sensor 122 into the user's body. The glucose sensor 122 is an electrochemical sensor that includes glucose oxidase, as is well known to those familiar with glucose sensor technology. The glucose oxidase enables the glucose sensor 122 to monitor the blood glucose level of a diabetic patient or user by performing a reaction of glucose and oxygen. Again, although certain embodiments relate to a glucose sensor, the technology described herein can be adapted for use with any of a variety of sensors known in the art. In general, the glucose sensor 122 can be positioned in the subcutaneous tissue of a user by the insertion needle 126 of the sensor inserter 104 to measure the glucose oxidase.

[0036] The sensor hub 124 is coupled to the sensor inserter 104 and to the adhesive patch 110. The sensor hub 124 is removably coupled to the sensor inserter 104. The sensor hub 124 can also feature electrical and physical interfaces and elements that house a sensor electronics module, e.g., a wireless transmitter that communicates with an infusion pump, a monitor device, etc. In certain embodiments, the sensor hub 124 is at least partially constructed of a plastic material. For the embodiments described herein, the majority of the sensor hub 124 is formed as a molded plastic part. In one example, the sensor hub 124 is formed of acrylonitrile butadiene styrene, nylon, acrylonitrile butadiene styrene polycarbonate blend, polyvinyl chloride, polytetrafluoroethylene (PTFE), polypropylene, polyether ether ketone (PEEK), polycarbonate, etc.

[0037] The adhesive patch 110 is coupled to the sensor base 124 and secures the sensor base 124, and thus the glucose sensor 122, to an anatomical structure, such as the skin of a user. The adhesive patch 110 is contained within the sensor inserter 104 during packaging and shipping and is exposed to the force of gravity G. The adhesive patch 110 can be constructed of a flexible, breathable material, such as cloth, bandage-like material, or the like, with one or more adhesive layers applied thereto. By way of example, suitable materials can include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers, with one or more adhesive layers applied thereto.

[0038] The sensor inserter 104 is coupled to the physiological property sensor 108 and is operable by a user to couple the glucose sensor 122 to the user. With continued reference to Figure 2 , the sensor inserter 104 includes a housing 130, a cradle or monitor support 132, one or more biasing components or springs 134, and a cover or cap 136. For example, in one instance, the housing 130 surrounds and encloses the physiological property sensor assembly 102 to enable sterilization of the physiological property sensor assembly 102. The housing 130 can include one or more features, such as a movable tab, that cooperate with the monitor support 132 to deploy the physiological property sensor 108 into an anatomical structure. The monitor support 132 is coupled to the physiological property sensor 108 and is movable relative to the housing 130 to deploy the physiological property sensor 108 into an anatomical structure. For example, an applied force to the housing 130 can bias the tab to release the monitor support 132 so that the spring 134 associated with the monitor support 132 is able to drive the monitor support 132 to deploy the physiological property sensor 108 into an anatomical structure. Once released, another spring 134b cooperates with the monitor support 132 to move the needle retractor 131 relative to the housing 130. The cap 136 surrounds a circumferential open end of the housing 130 and encloses the housing 130. Typically, the cap 136 is coupled to the housing 130 so that the adhesive patch 110 is not supported by the cap 136. As will be discussed, the anti-gravity system 112 inhibits or mitigates the force of gravity G from pulling down the unsupported adhesive patch 110, which in turn inhibits or mitigates sagging or drooping of the adhesive patch 110 within the sensor inserter 104, thereby ensuring full contact between the entire adhesive patch 110 and the anatomical structure of the user.

[0039] In one instance, the anti-gravity system 112 is shown in greater detail with reference to Figure 3 Figure 3 ​is a top view of the physiological property sensor assembly 102 illustrating the anti-gravity system 112 coupled to the adhesive patch 110. In this example, the anti-gravity system 112 is a low-tack adhesive cast paper coupled to the adhesive patch 110 and the monitor support 132 Figure 2 ). The anti-gravity system 112 includes a first top surface 140 and a second bottom surface 142 that are interconnected at a fold 144 Figure 4 ). The anti-gravity system 112 is substantially annular and defines an aperture 146 sized to enable the anti-gravity system 112 to be positioned about the perimeter of the sensor base 124. Typically, the anti-gravity system 112 is about the entire circumference of the sensor base 124 and can include a slit 148. If desired, the slit 148 enables a user to remove the anti-gravity system 112 from the adhesive patch 110 once the physiological property sensor 108 is coupled to the anatomy. In this example, the slit 148 is defined at an end 150 of the anti-gravity system 112 that includes the fold 144. The fold 144 can be configured such that the end 150 extends a distance Dl that is different from and less than a distance D2 of an opposite end 152 of the anti-gravity system 112. In this example, the anti-gravity system 112 is coupled to a surface 110a of the adhesive patch 110 along a perimeter 110b of the adhesive patch 110 and extends a distance D3 from the perimeter of the adhesive patch 110 toward the sensor base 124. Typically, the anti-gravity system 112 is spaced apart from the sensor base 124 by a fourth distance D4 that is different from and less than the distance D3.

[0040] In this example, with reference to Figure 4 , the anti-gravity system 112 is constructed from a laminar sheet 112a to which a low-tack adhesive 112b is applied. Typically, the low-tack adhesive 112b is applied to only a single surface of the laminar sheet 112a such that when folded, the top surface 140 and the bottom surface 142 include the low-tack adhesive 112b and an opposite surface 154 remains uncoated with the low-tack adhesive 112b. In one example, the laminar sheet 112a is constructed from paper, polycoated paper, a polymer (e.g., a polyester film or an HDPE film), or the like; and the low-tack adhesive 112b is constructed from silicone, acrylic, or the like. The low-tack adhesive 112b can be cast, coated, painted, or otherwise coupled to the laminar sheet 112a. The low-tack adhesive 112b along the bottom surface 142 is coupled or adhered to the surface 110a of the adhesive patch 110 and the low-tack adhesive 112b along the top surface 140 is coupled or adhered to the surface 132a of the monitor support 132 Figure 2As used herein, a “low-tack” adhesive is an adhesive with sufficiently weak adhesion that the adhesive is easily separated during its intended use (e.g., separating the pad from the adhesive patch before or after insertion). As used herein, a “high-tack” adhesive is an adhesive designed for permanent adhesion (i.e., no separation). For example, as used herein, a “low-tack” adhesive has a peel strength of approximately 0.5 oz / in. to approximately 5 oz / in. to stainless steel according to the ASTM D6862-11 standard test method for 90-degree peel resistance, and a “high-tack” adhesive has a peel strength greater than 5 oz / in. to stainless steel according to the ASTM D6862-11 standard test method for 90-degree peel resistance.

[0041] In one example, when the physiological characteristic sensor 108 is assembled and attached to the adhesive patch 110 to form an anti-gravity system 112, a low-tack adhesive 112b on the bottom surface 142 is attached to the adhesive patch 110 to surround the sensor base 124. The top surface 140 is folded over the bottom surface 142 at a fold 144. (Reference) Figure 3 With the physiological characteristic sensor assembly 102 assembled and the spring 134 and monitor support 132 connected to the housing 130, the physiological characteristic sensor assembly 102 is connected to the sensor inserter 104 such that a low-tack adhesive 112b is bonded to the surface 132a of the monitor support 132. With the physiological characteristic sensor assembly 102 connected to the monitor support 132, a cover 136 is connected to the housing 130 to surround the physiological characteristic sensor assembly 102. The sensor inserter 104, including the physiological characteristic sensor assembly 102, can be sterilized and shipped to the end user.

[0042] Once received, the user can remove cover 136 to expose the physiological characteristic sensor assembly 102. The user can operate sensor inserter 104 to deploy the physiological characteristic sensor assembly 102 onto the user. Once deployed, the low-tack adhesive 112b on top surface 140 allows sensor inserter 104 to be removed from physiological characteristic sensor assembly 102 without unattaching adhesive patch 110 from the user. With sensor inserter 104 unattached to physiological characteristic sensor assembly 102 and physiological characteristic sensor assembly 102 deployed on the user, the user can pull top surface 140 of antigravity system 112 to remove antigravity system 112 from adhesive patch 110 if needed.

[0043] By providing the low-tack adhesive 112b on the top surface 140, the sensor inserter 104 can be removed from the physiological property sensor 108 upon deployment without removing the adhesive patch 110 from the user. Thus, the anti-gravity system 112 can be removed from the sensor inserter 104 by the adhesive patch 110 when deploying the physiological property sensor 108. Further, the low-tack adhesive 112b on the bottom surface 142 allows for a larger adhesive patch 110 to be used while inhibiting sagging of the adhesive patch 110. In this regard, the anti-gravity system 112 increases the structure and rigidity of the portion of the adhesive patch 110 that extends beyond the sensor base 124 Figure 3 ). In other words, the anti-gravity system 112 maintains the adhesive patch 110 substantially perpendicular to the longitudinal axis LA1 of the sensor inserter 104, which ensures proper coupling to the user when deploying the adhesive patch 110. If desired, the fold 144 also allows the user to remove the anti-gravity system 112 upon deployment.

[0044] It should be noted that in other embodiments, the anti-gravity system 112 can be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, with reference to Figure 5 , a sensor introduction assembly 200 is shown. Since the sensor introduction assembly 200 includes the same or similar components as the sensor introduction assembly 100 discussed with respect to Figures 1 to 4 , the same reference numbers will be used to denote the same or similar components. Figure 5 is a schematic cross-sectional view taken from the perspective of line 2-2 of Figure 1 In this example, the sensor introduction assembly 200 includes a physiological property sensor assembly 202 and a sensor inserter 204. In this example, the physiological property sensor assembly 202 includes the physiological property sensor 108, the adhesive patch 110, and an anti-gravity system 212. Generally, the components of the physiological property sensor assembly 102 are coupled together as a single unit. The physiological property sensor assembly 202 and the sensor inserter 204 can be packaged together for consumer use.

[0045] The physiological property sensor 108 includes a glucose sensor 122 and a sensor base 124. Generally, the glucose sensor 122 can be positioned in the subcutaneous tissue of a user by an insertion needle of the sensor inserter 204 to measure glucose oxidase. The sensor base 124 is coupled to the sensor inserter 204 and to the adhesive patch 110. The sensor base 124 is removably coupled to the sensor inserter 204. The adhesive patch 110 is coupled to the sensor base 124 and affixes the sensor base 124 and, thus, the glucose sensor 122 to the skin of the user. The adhesive patch 110 is contained within the sensor inserter 204 during packaging and shipping and is exposed to the force of gravity G.

[0046] The sensor inserter 204 is coupled to the physiological property sensor 108 and is operable by a user to couple the glucose sensor 122 to the user. Briefly, the sensor inserter 204 includes a housing 230, a monitor support 232, and a cover or cap 236. For example, in one instance, the housing 230 surrounds and encloses the physiological property sensor assembly 202 to enable sterilization of the physiological property sensor assembly 202. The housing 230 can include one or more features that cooperate with the monitor support 232 to deploy the physiological property sensor 108 into the anatomy. The monitor support 232 is coupled to the physiological property sensor 108 and is operable by a user to deploy the physiological property sensor 108. The cap 236 surrounds a circumferential open end of the housing 230 and encloses the housing 230. Typically, the cap 236 is coupled to the housing 230 such that the adhesive patch 110 is not supported by the cap 236. As will be discussed, the anti-gravity system 212 inhibits or mitigates the force of gravity G pulling down on the unsupported adhesive patch 110, which in turn inhibits or mitigates sagging or drooping of the adhesive patch 110 within the sensor inserter 104, thereby ensuring full contact between the entire adhesive patch 110 and the user’s anatomy.

[0047] In one instance, reference is made to Figure 6 the anti-gravity system 212 is shown in greater detail. Figure 6 is a top view of the physiological property sensor assembly 202 illustrating the anti-gravity system 212 coupled to the adhesive patch 110. Reference is made to Figure 6 and 8 The anti-gravity system 212 includes a first top surface 240 and a second bottom surface 242 Figure 8 In Figure 8 the adhesive patch 110 is removed for clarity. The anti-gravity system 212 is substantially annular and defines an aperture 246 sized to enable the anti-gravity system 212 to be positioned around the perimeter of the sensor base 124. Typically, the anti-gravity system 212 surrounds the entire circumference of the sensor base 124. In this instance, reference is made to Figure 7 The anti-gravity system 212 is coupled to the surface 110a of the adhesive patch 110 along the perimeter 110b of the adhesive patch 110 and extends a distance D5 from the perimeter of the adhesive patch 110 to the sensor base 124. Typically, the anti-gravity system 212 is spaced apart from the sensor base 124 by a sixth distance D6 that is different from and less than the distance D5.

[0048] In this instance, the anti-gravity system 212 is a double-sided differential adhesive that includes a high-tack adhesive layer 250 coupled to a low-tack adhesive layer 252. The high-tack adhesive layer 250 is coupled to the monitor support 232 (Figure 5 ), and a low-tack adhesive layer 252 is coupled to the adhesive patch 110. In this example, the high-tack adhesive 250a is coupled to or formed on opposite sides of the base layer. The base layer is composed of paper, polycoated paper, a polymer such as a polyester film or an HDPE film, or the like. The top surface 240 of the anti-gravity system 212 is defined by one side 250b of the high-tack adhesive layer 250, which is coupled to or formed on the base layer. In one example, the high-tack adhesive 250a is composed of silicone, acrylic, or the like. The high-tack adhesive 250a can be cast, coated, painted, or otherwise coupled to the base layer. The opposite side 250c of the high-tack adhesive layer 250 formed on the base layer is coupled or adhered to the low-tack adhesive layer 252.

[0049] In this example, the low-tack adhesive 252a is coupled to or formed on opposite sides of the second base layer. The bottom surface 242 of the anti-gravity system 212 is defined by one side 252b of the low-tack adhesive layer 252, which is coupled to or formed on the second base layer. The second base layer is composed of paper, polycoated paper, a polymer such as a polyester film or an HDPE film. In one example, the low-tack adhesive 252a is composed of silicone, acrylic, or the like. The low-tack adhesive 252a can be cast, coated, painted, or otherwise coupled to the second base layer. The opposite side 252c of the low-tack adhesive layer 252 formed on the second base layer is coupled or adhered to the side 250c of the high-tack adhesive layer 250 to form the anti-gravity system 212. Thus, the high-tack adhesive 250a is a first tacky adhesive, and the low-tack adhesive 252a is a second tacky adhesive, where the second tacky adhesive is different from and less than the first tacky adhesive. It should be noted that the base layer and the second base layer are not shown in the drawings for ease of illustration, as these paper or film layers have a predetermined nominal thickness.

[0050] In one example, with the physiological characteristic sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 212, the reference Figure 5 , the low-tack adhesive layer 252 on the bottom surface 242 is coupled to the adhesive patch 110 so as to surround the sensor base 124. With the physiological characteristic sensor assembly 202 assembled and the monitor support 232 coupled to the housing 230, the physiological characteristic sensor assembly 202 is coupled to the sensor inserter 204 such that the high-tack adhesive layer 250 is coupled to the surface 232a of the monitor support 232. With the physiological characteristic sensor assembly 202 coupled to the monitor support 232, the cover 236 is coupled to the housing 230 to enclose the physiological characteristic sensor assembly 202. The sensor inserter 204 including the physiological characteristic sensor assembly 202 can be sterilized and shipped to an end user.

[0051] Once received, the user can remove the cover 236 to expose the physiological property sensor assembly 202. The user can operate the sensor inserter 204 to deploy the physiological property sensor assembly 202 onto the user. Once deployed, the high-tack adhesive layer 250 on the top surface 240 retains the anti-gravity system 212 on the sensor inserter 204, and the low-tack adhesive layer 252 enables the anti-gravity system 212 to be removed from the adhesive patch 110 without having to decouple the adhesive patch 110 from the user. Thus, the anti-gravity system 212 can be removed from the adhesive patch 110 by the sensor inserter 204 when the physiological property sensor 108 is deployed. When the physiological property sensor 108 is coupled to the user by the adhesive patch 110, the differential adhesive of the anti-gravity system 212 enables the sensor inserter 204 to be decoupled from the physiological property sensor 108 without having to decouple the physiological property sensor 108 and the adhesive patch 110 from the user.

[0052] By providing the high-tack adhesive layer 250 on the top surface 240 and the low-tack adhesive layer 252 on the bottom surface 242, the anti-gravity system 212 is retained on the sensor inserter 204 and removable from the physiological property sensor 108 when deployed without having to remove the adhesive patch 110 from the user. Moreover, the low-tack adhesive layer 252 on the bottom surface 242 allows for a larger adhesive patch 110 to be used while inhibiting sagging of the adhesive patch 110. In this regard, the anti-gravity system 212 increases the structure and rigidity of the portion of the adhesive patch 110 that extends beyond the sensor base 124. In other words, the anti-gravity system 212 maintains the adhesive patch 110 substantially perpendicular to the longitudinal axis LA2 of the sensor inserter 204, which ensures proper coupling to the user when the adhesive patch 110 is deployed.

[0053] It should be noted that in other embodiments, the anti-gravity system 112 can be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, with reference to Figure 9 , a sensor introduction assembly 300 is shown. As the sensor introduction assembly 300 includes the same or similar components as the sensor introduction assembly 100 discussed with respect to Figures 1 to 4 and the sensor introduction assembly 200 discussed with respect to Figures 5 to 8 , the same reference numbers will be used to denote the same or similar components. Figure 9 is from Figure 1a perspective view taken along line 2-2 of FIG. 2. In this example, the sensor introduction assembly 300 includes a physiological property sensor assembly 302 and a sensor inserter 204. In this example, the physiological property sensor assembly 302 includes a physiological property sensor 108, an adhesive patch 110, and an anti-gravity system 312. Generally, the components of the physiological property sensor assembly 302 are coupled together as a single unit. The physiological property sensor assembly 302 and the sensor inserter 204 can be packaged together for use by a consumer.

[0054] The physiological property sensor 108 includes a glucose sensor 122 and a sensor base 124. The sensor base 124 is coupled to the sensor inserter 204 and to the adhesive patch 110. The sensor base 124 is removably coupled to the sensor inserter 204. The adhesive patch 110 is coupled to the sensor base 124 and affixes the sensor base 124, and thus the glucose sensor 122, to the skin of a user. The adhesive patch 110 is contained within the sensor inserter 204 during packaging and shipping and is exposed to the force of gravity G.

[0055] The sensor inserter 204 is coupled to the physiological property sensor 108 and is operable by a user to couple the glucose sensor 122 to a user. Briefly, the sensor inserter 204 includes a housing 230, a monitor support 232, and a cover or cap 236. For example, in one example, the housing 230 surrounds and encloses the physiological property sensor assembly 302 to enable sterilization of the physiological property sensor assembly 302. The housing 230 can include one or more features that cooperate with the monitor support 232 to deploy the physiological property sensor 108 into an anatomical structure. The monitor support 232 is coupled to the physiological property sensor 108 and is operable by a user to deploy the physiological property sensor 108. The cap 236 surrounds a circumferential open end of the housing 230 and encloses the housing 230. Generally, the cap 236 is coupled to the housing 230 such that the adhesive patch 110 is not supported by the cap 236. As will be discussed, the anti-gravity system 312 inhibits or mitigates the force of gravity G from pulling down the unsupported adhesive patch 110, which in turn inhibits or mitigates sagging or drooping of the adhesive patch 110 within the sensor inserter 204, thereby ensuring full contact between the entire adhesive patch 110 and the anatomical structure of a user.

[0056] In one example, reference is made to Figure 10 the anti-gravity system 312 is shown in greater detail. Figure 10 is a top view of the physiological property sensor assembly 302 illustrating the anti-gravity system 312 coupled to the adhesive patch 110. Reference is made to Figure 10 and 11The anti-gravity system 312 includes a first top surface 340 and a second bottom surface 342 Figure 11 ). The anti-gravity system 312 is substantially annular and defines a hole 346 sized to enable the anti-gravity system 312 to be positioned about the perimeter of the sensor base 124 Figure 10 ). Typically, the anti-gravity system 312 extends about the entire circumference of the sensor base 124. In this example, with reference to Figure 11 The anti-gravity system 312 is coupled to the surface 110a of the adhesive patch 110 along the perimeter 110b of the adhesive patch 110 and extends a distance D7 from the perimeter of the adhesive patch 110 toward the sensor base 124. Typically, the anti-gravity system 312 is spaced apart from the sensor base 124 by an eighth distance D8 that is different from and less than the distance D7.

[0057] In this example, the anti-gravity system 312 is a single layer double sided differential adhesive that includes a high tack adhesive 350 on a first side 312a and a low tack adhesive 352 on a second side 312b. The high tack adhesive 350 is coupled to the monitor support 332 Figure 9 ) and the low tack adhesive 352 is coupled to the adhesive patch 110. In this example, the high tack adhesive 350 and the low tack adhesive 352 are both coupled to or formed on opposite sides of a base layer. The base layer is constructed of paper, polycoated paper, a polymer such as a polyester film or an HDPE film. The top surface 340 of the anti-gravity system 312 is defined by the high tack adhesive 350 and the bottom surface 342 of the anti-gravity system 312 is defined by the low tack adhesive 352, which are coupled to or formed on opposite sides of the base layer. In one example, the high tack adhesive 350 is constructed of synthetic rubber adhesive, acrylic, or the like. The high tack adhesive 350 can be cast, coated, painted, or otherwise coupled to the base layer. The low tack adhesive 352 is coupled to or formed on the second opposite side of the base layer. In one example, the low tack adhesive 352 is constructed of silicone, acrylic, or the like. The low tack adhesive 352 can be cast, coated, painted, or otherwise coupled to the base layer. It should be noted that the base layer is not shown in the drawings for ease of illustration as this paper or film layer has a predetermined nominal thickness.

[0058] In one example, with the physiological property sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 312, with reference to Figure 9A low-tack adhesive 352 on the bottom surface 342 is attached to the adhesive patch 110 to surround the sensor base 124. With the physiological characteristic sensor assembly 302 assembled and the monitor support 232 attached to the housing 230, the physiological characteristic sensor assembly 302 is attached to the sensor inserter 204 such that a high-tack adhesive 350 is attached to the surface 232a of the monitor support 232. With the physiological characteristic sensor assembly 302 attached to the monitor support 232, a cover 236 is attached to the housing 230 to surround the physiological characteristic sensor assembly 302. The sensor inserter 204, including the physiological characteristic sensor assembly 302, can be sterilized and shipped to the end user.

[0059] Once received, the user can remove cover 236 to expose the physiological characteristic sensor assembly 302. The user can operate sensor inserter 204 to deploy the physiological characteristic sensor assembly 302 onto the user. Once deployed, high-tack adhesive 350 on top surface 340 retains the anti-gravity system 312 on sensor inserter 204, and low-tack adhesive 352 allows the anti-gravity system 312 to be removed from adhesive patch 110 without detaching adhesive patch 110 from the user. Therefore, when physiological characteristic sensor 108 is attached to the user via adhesive patch 110, the differential adhesive of anti-gravity system 312 allows sensor inserter 204 to detach from physiological characteristic sensor 108 without detaching physiological characteristic sensor 108 and adhesive patch 110 from the user.

[0060] By providing a high-tack adhesive 350 on the top surface 340 and a low-tack adhesive 352 on the bottom surface 342, the anti-gravity system 312 remains on the sensor inserter 204 and can be removed from the physiological characteristic sensor 108 during deployment without removing the adhesive patch 110 from the user. Therefore, when deploying the physiological characteristic sensor 108, the anti-gravity system 312 can be removed from the adhesive patch 110 through the sensor inserter 204. Furthermore, the low-tack adhesive 352 on the bottom surface 342 allows for the use of a larger adhesive patch 110 while suppressing sagging. In this respect, the anti-gravity system 312 increases the structure and rigidity of the portion of the adhesive patch 110 extending beyond the sensor base 124. In other words, the anti-gravity system 312 maintains the adhesive patch 110 substantially perpendicular to the longitudinal axis LA2 of the sensor inserter 204, which ensures proper attachment to the user when deploying the adhesive patch 110.

[0061] It should be noted that in other embodiments, the anti-gravity system 112 can be configured differently to suppress or mitigate the effects of gravity on the adhesive patch 110. For example, see Reference Figure 12The sensor introduction assembly 400 is shown. Because the sensor introduction assembly 400 includes components related to... Figures 1 to 4 The sensor introduction assembly 100 under discussion and about Figures 5 to 8 The sensor introduced in the discussion is the same as or similar to the assembly 200, and the same reference numerals will be used to denote the same or similar components. Figure 12 From Figure 1 A schematic cross-sectional view taken from the perspective view of line 2-2. In this example, the sensor introduction assembly 400 includes a physiological characteristic sensor assembly 402 and a sensor inserter 204. In this example, the physiological characteristic sensor assembly 402 includes a physiological characteristic sensor 108, an adhesive patch 110, and an anti-gravity system 412. Typically, the components of the physiological characteristic sensor assembly 402 are connected together as a single unit. The physiological characteristic sensor assembly 402 and the sensor inserter 204 can be packaged together for consumer use.

[0062] The physiological characteristic sensor 108 includes a glucose sensor 122 and a sensor base 124. The sensor base 124 is coupled to a sensor inserter 204 and to an adhesive patch 110. The sensor base 124 is removably coupled to the sensor inserter 204. The adhesive patch 110 is coupled to the sensor base 124 and attaches the sensor base 124, and thus the glucose sensor 122, to the user's skin. The adhesive patch 110 is contained within the sensor inserter 204 during packaging and shipping and is exposed to gravity G.

[0063] Sensor inserter 204 is coupled to physiological characteristic sensor 108 and can be user-operated to couple glucose sensor 122 to a user. In short, sensor inserter 204 includes housing 230, monitor support 232, and cap or cover 236. For example, in one instance, housing 230 surrounds and encloses physiological characteristic sensor assembly 202 to enable sterilization of physiological characteristic sensor assembly 202. Housing 230 may include one or more features that cooperate with monitor support 232 to deploy physiological characteristic sensor 108 into an anatomical structure. Monitor support 232 is coupled to physiological characteristic sensor 108 and can be user-operated to deploy physiological characteristic sensor 108 into an anatomical structure. Cover 236 surrounds and encloses housing 230 around a circumferentially open end of housing 230. Typically, cover 236 is coupled to housing 230 such that adhesive patch 110 is not supported by cover 236. As will be discussed, the anti-gravity system 412 suppresses or mitigates the downward pull of gravity G on the unsupported adhesive patch 110, which in turn suppresses or mitigates the sagging or sinking of the adhesive patch 110 within the sensor inserter 204, thereby ensuring full contact between the entire adhesive patch 110 and the user's anatomy.

[0064] In one example, reference is made to Figure 13 the anti-gravity system 412 is shown in greater detail. Figure 13 is a top view of the physiological property sensor assembly 402 illustrating the anti-gravity system 412 coupled to the adhesive patch 110. In this example, the anti-gravity system 412 includes a plurality of adhesive strips 414 spaced around the perimeter of the sensor base 124. The plurality of adhesive strips 414 are also spaced around the perimeter or circumference of the adhesive patch 110. In this example, the anti-gravity system 412 includes four adhesive strips 414, but it should be understood that the anti-gravity system 412 can include any number of adhesive strips 414.

[0065] Each of the adhesive strips 414 includes a first top surface 440 and a second bottom surface 442 Figure 14 ). Each of the adhesive strips 414 is rectangular with rounded edges. However, it should be noted that the adhesive strips 414 can have any desired shape, and further, one or more of the adhesive strips 414 can have a different shape. In this example, each of the adhesive strips 414 has a length LI and a width Wl. The length LI and the width Wl are each predefined to ensure that the adhesive strips 414 provide rigidity to the adhesive patch 110 while also ensuring that the adhesive strips 414 do not interfere with the removal of the adhesive patch 110 from the sensor inserter 204, as will be discussed below. In one example, the length LI is about 100 micrometers (pm) to about 1.0 millimeter (mm); and the width Wl is about 100 micrometers (pm) to about 5.0 millimeters (mm). Generally, the dimensions and positions of the adhesive strips 414 are set to interface with the monitor support 232. Each of the adhesive strips 414 is positioned a distance D9 from the perimeter 110b of the adhesive patch 110 and a distance DlO from the perimeter of the sensor base 124. In one example, the distance D9 is about equal to or the same as the distance DlO and is about 0 millimeters (mm) to about 10 millimeters (mm).

[0066] In this example, each of the adhesive strips 414 includes a differential double-sided adhesive including a high tack adhesive 450 on the top surface 440 and a low tack adhesive 452 on the bottom surface 442. The high tack adhesive 450 on the top surface 440 is coupled to the monitor support 232 Figure 12), and a low-tack adhesive 452 on the bottom surface 442 of the anti-gravity system 412 is coupled to the adhesive patch 110. The top surface 440 of the anti-gravity system 412 is defined by a high-tack adhesive 450 and the bottom surface 442 of the anti-gravity system 412 is defined by a low-tack adhesive 452. In this example, the high-tack adhesive 450 and the low-tack adhesive 452 are both coupled to or formed on opposite sides of a base layer. The base layer is composed of paper, poly-coated paper, a polymer (e.g., a polyester film or an HDPE film). In one example, the high-tack adhesive 450 is composed of a synthetic rubber adhesive, an acrylic, or the like. The high-tack adhesive 450 can be cast, coated, painted, or otherwise coupled to the base layer. The low-tack adhesive 452 is coupled to or formed on the second opposite side of the base layer. In one example, the low-tack adhesive 452 is composed of a silicone, an acrylic, or the like. The low-tack adhesive 452 can be cast, coated, painted, or otherwise coupled to the base layer. It should be noted that the base layer is not shown in the drawings for ease of illustration as this paper or film layer has a predetermined nominal thickness.

[0067] In one example, with the physiological characteristic sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 412, the reference Figure 5 , the adhesive strip 414 is coupled to the adhesive patch 110 (via the low-tack adhesive 452 on the bottom surface 442) so as to be spaced apart around the perimeter 110b of the adhesive patch 110. With the physiological characteristic sensor assembly 402 assembled and the monitor support 232 coupled to the housing 230, the physiological characteristic sensor assembly 402 is coupled to the sensor inserter 204 such that the high-tack adhesive 450 of the top surface 440 is coupled to the surface 232a of the monitor support 232. With the physiological characteristic sensor assembly 402 coupled to the monitor support 232, the cover 236 is coupled to the housing 230 to enclose the physiological characteristic sensor assembly 402. The sensor inserter 204 including the physiological characteristic sensor assembly 402 can be sterilized and shipped to an end user.

[0068] Once received, the user can remove the cover 236 to expose the physiological characteristic sensor assembly 402. The user can operate the sensor inserter 204 to deploy the physiological characteristic sensor assembly 402 onto the user. Once deployed, the high-tack adhesive 450 on the top surface 440 retains the anti-gravity system 412 on the sensor inserter 204. Thus, the anti-gravity system 412 is removable from the adhesive patch 110 by the sensor inserter 204 when the physiological characteristic sensor 108 is deployed. When the physiological characteristic sensor 108 is coupled to the user by the adhesive patch 110, the anti-gravity system 412 enables the sensor inserter 204 to be decoupled from the physiological characteristic sensor 108 without having to decouple the physiological characteristic sensor 108 and the adhesive patch 110 from the user.

[0069] By providing an adhesive strip 414 with a high-tack adhesive layer 250 on the top surface 440 and a low-tack adhesive layer 452 on the bottom surface 442, the anti-gravity system 412 remains on the sensor inserter 204 and is removable from the physiological property sensor 108 upon deployment without removing the adhesive patch 110 from the user. Further, the anti-gravity system 412 allows for the use of a larger adhesive patch 110 while inhibiting sagging of the adhesive patch 110. In this regard, the anti-gravity system 412 increases the structure and rigidity of the portion of the adhesive patch 110 that extends beyond the sensor base 124. In other words, the anti-gravity system 412 maintains the adhesive patch 110 substantially perpendicular to the longitudinal axis LA2of the sensor inserter 204, which ensures proper coupling to the user upon deployment of the adhesive patch 110.

[0070] It should be noted that in other embodiments, the anti-gravity system 112 can be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, with reference to Figure 15 , a sensor introduction assembly 500 is shown. Since the sensor introduction assembly 500 includes the same or similar components as the sensor introduction assembly 100 discussed with respect to Figures 1 to 4 and the sensor introduction assembly 200 discussed with respect to Figures 5 to 8 , the same reference numerals will be used to denote the same or similar components. Figure 15 is a schematic cross-sectional view taken from a perspective view of line 2-2 of Figure 1 In this example, the sensor introduction assembly 500 includes a physiological property sensor assembly 502 and a sensor inserter 504. In this example, the physiological property sensor assembly 502 includes the physiological property sensor 108, an adhesive skin patch or adhesive patch 510, and an anti-gravity system 512. Generally, the components of the physiological property sensor assembly 502 are coupled together as a single unit. The physiological property sensor assembly 502 and the sensor inserter 504 can be packaged together for use by a consumer.

[0071] The physiological property sensor 108 includes the glucose sensor 122 and the sensor base 124. Generally, the glucose sensor 122 can be positioned in the subcutaneous tissue of a user by the insertion needle of the sensor inserter 504 to measure glucose oxidase. The sensor base 124 is coupled to the sensor inserter 504 and to the adhesive patch 110. The sensor base 124 is removably coupled to the sensor inserter 204.

[0072] The adhesive patch 510 is coupled to the sensor base 124 and secures the sensor base 124, and thus the glucose sensor 122, to the user's skin. The adhesive patch 510 is contained within the sensor inserter 504 during packaging and shipping and is exposed to the force of gravity G. The adhesive patch 510 can be constructed of a flexible, breathable material with one or more adhesive layers, such as cloth, bandage-like material, or the like. By way of example, suitable materials can include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers, with one or more adhesive layers applied to the material. In this example, the adhesive patch 510 includes a charged surface or a first charged surface 510a. The first charged surface 510a opposes a surface 510b that is coupled to the user. In one example, the first charged surface 510a has a positive charge that cooperates with a negatively charged surface of the sensor inserter 504, as will be discussed. In other examples, the first charged surface 510a can have a negatively charged surface that cooperates with a corresponding positively charged surface of the sensor inserter 504. The first charged surface 510a can be charged using contact-induced charge separation, charge-induced charge separation, or the like. For contact-induced charge separation, the amount of charge and the polarity of the charge applied depends on the material and the surface roughness.

[0073] The sensor inserter 504 is coupled to the physiological characteristic sensor 108 and is operable by the user to couple the glucose sensor 122 to the user. Briefly, the sensor inserter 504 includes a housing 230, a monitor support 532, and a cover or cap 236. For example, in one example, the housing 230 surrounds and encloses the physiological characteristic sensor assembly 502 to enable sterilization of the physiological characteristic sensor assembly 502. The housing 230 can include one or more features that cooperate with the monitor support 532 to deploy the physiological characteristic sensor 108 into the anatomy. The monitor support 532 is coupled to the physiological characteristic sensor 108 and is operable by the user to deploy the physiological characteristic sensor 108 into the anatomy. In this example, the monitor support 532 includes a charged surface or a second charged surface 532a. The second charged surface 532a faces the adhesive patch 110. In one example, the second charged surface 532a has a negative charge that cooperates with the first charged surface 510a of the adhesive patch 510. The second charged surface 532a can be charged using contact-induced charge separation, charge-induced charge separation, or the like. For contact-induced charge separation, the amount of charge and the polarity of the charge applied depends on the material and the surface roughness.

[0074] In an example of contact-induced charge separation, the first charged surface 510a of the adhesive patch 510 is composed of a material (e.g., a polyurethane film) that carries more negative charge in a triboelectric series. The second charged surface 532a of the monitor support 532 is composed of a material (e.g., nylon) that carries more positive charge than the material of the first charged surface 510a of the adhesive patch 510 in the triboelectric series. Contact between the first charged surface 510a and the second charged surface 532a results in adhesion between the two surfaces 510a, 532a as electrons are exchanged and attracted by opposite charges built up on each surface, which inhibits sagging of the adhesive patch 510. It should be noted that the materials chosen herein are merely examples, as any materials that separate from one another along a triboelectric series can be used for the adhesive patch 510 and the monitor support 532, so long as contact between the first charged surface 510a and the second charged surface 532a results in adhesion between the two surfaces 510a, 532a as a result of electron exchange and attraction by opposite charges built up on the respective surfaces 510a, 532a. It should be noted that the entirety of the monitor support 532 can be composed of the predetermined material, or only the surface of the monitor support 532 (e.g., the second charged surface 532a) can be formed of the predetermined material.

[0075] In an example of charge-induced charge separation, the first charged surface 510a can initially be composed of an electrically neutral material (e.g., a polyester that has been electrically grounded to have a net neutral charge). A negatively charged object can be brought near the first charged surface 510a to induce a positive charge on the first charged surface 510a as positive charges associated with the first charged surface 510a move to the negatively charged object. Similarly, the second charged surface 532a can be composed of an electrically neutral material (e.g., a polycarbonate that has been electrically grounded to have a net neutral charge). A positively charged object can be brought near the second charged surface 532a to induce a negative charge on the second charged surface 532a as negative charges associated with the first charged surface 510a move to the positively charged object. When the physiological characteristic sensor 108 is coupled to the sensor inserter 504, the negatively charged second charged surface 532a attracts the positively charged first charged surface 510a, which inhibits sagging of the adhesive patch 510.

[0076] The cover 236 surrounds the circumferential open end of the housing 230 and encloses the housing 230. Typically, the cover 236 is coupled to the housing 230 such that the adhesive patch 510 is not supported by the cover 236. As discussed, the anti-gravity system 512 inhibits or mitigates the downward pull of gravity G on the unsupported adhesive patch 510, which in turn inhibits or mitigates sagging or sinking of the adhesive patch 510 within the sensor inserter 204, thereby ensuring that full contact is formed between the entire adhesive patch 510 and the user’s anatomy.

[0077] In one example, with the physiological characteristic sensor 108 assembled and coupled to the adhesive patch 510 and the anti-gravity system 512 formed, the first electrically charged surface 510a is charged to have a corresponding electrical charge, in this example, a positive charge. The second electrically charged surface 532a of the monitor support 532 is charged to have a corresponding electrical charge, in this example, a negative charge. With the physiological characteristic sensor assembly 502 assembled and the monitor support 532 coupled to the housing 230, the physiological characteristic sensor assembly 502 is coupled to the sensor inserter 504 such that the first electrically charged surface 510a of the adhesive patch 510 is electrically attracted to the second electrically charged surface 532a of the monitor support 532. With the physiological characteristic sensor assembly 502 coupled to the monitor support 532, the cover 236 is coupled to the housing 230 to enclose the physiological characteristic sensor assembly 502. The sensor inserter 504, including the physiological characteristic sensor assembly 502, can be sterilized and shipped to an end user.

[0078] Once received, the user can remove the cover 236 to expose the physiological characteristic sensor assembly 502. The user can operate the sensor inserter 504 to deploy the physiological characteristic sensor assembly 502 onto the user. The weak attractive force between the first electrically charged surface 510a and the second electrically charged surface 532a enables the sensor inserter 504 to be removed from the physiological characteristic sensor assembly 502. Thus, when the physiological characteristic sensor 108 is coupled to the user through the adhesive patch 510, the anti-gravity system 512 enables the sensor inserter 504 to be decoupled from the physiological characteristic sensor 108 without requiring the physiological characteristic sensor 108 and the adhesive patch 510 to be decoupled from the user. Further, by providing an attractive force between the first electrically charged surface 510a and the second electrically charged surface 532a, the anti-gravity system 512 allows for a larger adhesive patch 110 to be used while inhibiting sagging of the adhesive patch 510. In this regard, the attractive force between the first electrically charged surface 510a and the second electrically charged surface 532a maintains the adhesive patch 510 substantially perpendicular to the longitudinal axis LA5 of the sensor inserter 504, which ensures proper coupling to the user when the adhesive patch 510 is deployed. In other words, the adhesive patch 510 includes a first electrically charged surface or a first electrically charged surface 510a having a first electrical charge, in this example, a positive charge, the sensor inserter 504 includes a second electrically charged surface or a second electrically charged surface 532a having a second electrical charge, in this example, a negative charge, and the first electrical charge is different than the second electrical charge to maintain the adhesive patch 510 substantially perpendicular to the longitudinal axis LA5 of the sensor inserter 504.

[0079] It should be noted that the sensor inserters 104, 204, 504 described and illustrated herein are exemplary only, as any device can be used with the anti-gravity systems 112, 212, 312, 412, 512 to deploy a physiological property sensor 108 into an anatomical structure. For example, an exemplary sensor inserter can include only a monitor support, such as the monitor support 232, 532, which is manually operated by a user to deploy a physiological property sensor 108 into an anatomical structure. Further, it should be noted that the sensor inserters 204, 504 can incorporate aspects of the sensor inserter 104 discussed or the insertion device described in commonly-assigned U.S. Patent Publication No. 2017 / 0290533 to Antonio et al., the relevant portions of which are previously incorporated by reference herein. Figures 1 to 4 The sensor inserter 104 discussed or the insertion device described in commonly-assigned U.S. Patent Publication No. 2017 / 0290533 to Antonio et al., the relevant portions of which are previously incorporated by reference herein.

[0080] While at least one exemplary embodiment has been presented in the foregoing detailed description of the specific embodiments, it should be appreciated that a vast number of modifications can be made to the exemplary embodiments without departing from the scope of the claimed subject matter. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope of the claimed subject matter in any way but rather are intended to encompass all changes, alternatives, and modifications that could be made to and by the exemplary embodiment(s) described herein under the scope of the claimed subject matter. Accordingly, the scope of the claimed subject matter is to be understood as not limited by the specific illustrative embodiments that have been presented but only by the claims that there are now being presented, the full scope of which is to be determined by the appended claims.

[0081] It should be understood that various aspects disclosed herein can be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that words denoting orientation, such as for example, "vertical", "horizontal", "up", "down", and the like, are used herein merely to facilitate discussion, but not to limit the application in any way. Further, it should be understood that each historical event described herein can be performed in a different order than the order specifically recited in the description and accompanying drawings. It should also be understood that certain actions or events that are described in conjunction with one or more of the example processes or methods described herein can be performed in a different order than the order specifically recited in the description and accompanying drawings. Additionally, it should be understood that certain actions or events that are described in conjunction with one or more of the example processes or methods described herein can be performed concurrently, in response to a single event, or in any suitable order. Furthermore, it should be understood that the processes or methods described herein can be performed by a single module or a combination of modules.

[0082] Group A

[0083] Paragraph Al. A system for deploying a physiological property sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological property sensor, the adhesive patch coupling the physiological property sensor to an anatomical structure; and an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter, the anti-gravity system maintaining the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

[0084] Paragraph A2. The system of paragraph Al, wherein the anti-gravity system comprises at least one adhesive layer coupled to a surface of the adhesive patch and to be coupled to a surface of the sensor inserter.

[0085] Paragraph A3. The system of paragraph A2, wherein the at least one adhesive layer is a differential double-sided adhesive.

[0086] Paragraph A4. The system of paragraph Al, A2, or A3, wherein the at least one adhesive layer comprises a plurality of adhesive strips spaced around a perimeter of the adhesive patch.

[0087] Paragraph A5. The system of paragraph A2, wherein the at least one adhesive layer comprises a first tacky adhesive on a first side and a second tacky adhesive on an opposite side, the second tacky adhesive being less tacky than the first tacky adhesive.

[0088] Paragraph A6. The system of paragraph A5, wherein the first tacky adhesive is to be coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

[0089] Paragraph A7. The system of paragraph Al, wherein the anti-gravity system comprises a plurality of adhesive layers coupled between a surface of the adhesive patch and a surface to be coupled to the sensor inserter.

[0090] Paragraph A8. The system of paragraph A7, wherein a first adhesive layer of the plurality of adhesive layers comprises a first tacky adhesive on opposite sides and a second adhesive layer of the plurality of adhesive layers comprises a second tacky adhesive on opposite sides, the second tacky adhesive being less tacky than the first tacky adhesive.

[0091] Paragraph A9. The system of paragraph A8, wherein the first tacky adhesive is to be coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

[0092] Paragraph A10. The system of Paragraph A1, wherein the adhesive patch includes a first charged surface having a first charge, the sensor inserter includes a second charged surface having a second charge, and the first charge is different than the second charge to maintain the adhesive patch substantially perpendicular to the longitudinal axis of the sensor inserter.

[0093] Paragraph A11. A system for deploying a physiological property sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological property sensor, the adhesive patch coupling the physiological property sensor to an anatomical structure; and an anti-gravity system coupled to the adhesive patch and the sensor inserter, the anti-gravity system including at least one adhesive layer coupled between the adhesive patch and the sensor inserter, the at least one adhesive layer coupled to a surface of the adhesive layer so as to be positioned around at least a portion of a perimeter of the adhesive patch, and the anti-gravity system maintaining the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor, and removable from the adhesive patch by the sensor inserter upon deployment of the physiological property sensor.

[0094] Paragraph A12. The system of Paragraph A11, wherein the at least one adhesive layer is a differential double-sided adhesive and comprises a plurality of adhesive strips, the plurality of adhesive strips spaced around the perimeter of the adhesive patch.

[0095] Paragraph A13. The system of Paragraph A11, wherein the at least one adhesive layer is a differential double-sided adhesive layer.

[0096] Paragraph A14. The system of Paragraph A13, wherein the at least one adhesive layer comprises a first tacky adhesive on a first side and a second tacky adhesive on an opposite side, the second tacky adhesive less tacky than the first tacky adhesive, and the first tacky adhesive coupled to the sensor inserter and the second tacky adhesive coupled to the adhesive patch.

[0097] Paragraph A15. The system of Paragraph A11, wherein the anti-gravity system comprises a plurality of adhesive layers coupled between a surface of the adhesive patch and a surface of the sensor inserter, wherein a first adhesive layer of the plurality of adhesive layers comprises a first tacky adhesive on opposite sides, and a second adhesive layer of the plurality of adhesive layers comprises a second tacky adhesive on opposite sides, the second tacky adhesive less tacky than the first tacky adhesive, the first tacky adhesive coupled to the sensor inserter, and the second tacky adhesive coupled to the adhesive patch.

[0098] Paragraph A16. A system for deploying a physiological property sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological property sensor, the adhesive patch coupling the physiological property sensor to an anatomical structure; and an anti-gravity system coupled to the adhesive patch and the sensor inserter, the anti-gravity system including at least one adhesive layer coupled between the adhesive patch and the sensor inserter, the at least one adhesive layer coupled to a surface of the adhesive layer so as to be positioned around a perimeter of the adhesive patch, the at least one adhesive layer comprising a first tacky adhesive on a first side and a second tacky adhesive on an opposite side, the second tacky adhesive being less tacky than the first tacky adhesive, and the anti-gravity system maintaining the adhesive patch substantially perpendicular to a longitudinal axis of sensor inserter prior to deployment of the physiological property sensor, and removable from the adhesive patch by the sensor inserter upon deployment of physiological property sensor.

[0099] Paragraph A17. The system of paragraph A16, wherein the first tacky adhesive is coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

[0100] Paragraph A18. The system of paragraph A17, wherein the anti-gravity system comprises a plurality of adhesive layers coupled between a surface of the adhesive patch and a surface of the sensor inserter, wherein a first adhesive layer of the plurality of adhesive layers comprises the first tacky adhesive defining the first side, and a second adhesive layer of the plurality of adhesive layers comprises the second tacky adhesive defining the second side.

[0101] Group B

[0102] Paragraph B1. A system for deploying a physiological property sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological property sensor, the adhesive patch coupling the physiological property sensor to an anatomical structure; and

[0103] an anti-gravity system coupled to the adhesive patch and to be coupled to the sensor inserter, the anti-gravity system maintaining the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor, and the anti-gravity system removable from the sensor inserter by the adhesive patch upon deployment of the physiological property sensor.

[0104] Paragraph B2. The system of paragraph B1, wherein the anti-gravity system comprises an adhesive paper coupled between the adhesive patch and the sensor inserter.

[0105] Paragraph B3. The system of Paragraphs B1 or B2, wherein the anti- gravity system comprises a first surface opposite a second surface and defines an aperture through the first surface and the second surface to enable the anti-gravity system to be positioned about a perimeter of the physiological property sensor.

[0106] Paragraph B4. The system of Paragraph B3, wherein the anti-gravity system comprises a first end opposite a second end and the anti-gravity system comprises a fold at the first end to define the first surface by positioning the first surface above the second surface.

[0107] Paragraph B5. The system of Paragraph B4, wherein the anti-gravity system comprises a slit at the first end, the slit extending through the fold to enable the anti-gravity system to be removed from the adhesive patch after deployment.

[0108] Paragraph B6. The system of Paragraph B4, wherein the anti-gravity system extends a first distance at the first end and a second distance at the second end, the first distance being different than the second distance.

[0109] Paragraph B7. The system of Paragraph B3, wherein the first surface is coupled to the sensor inserter and the second surface is coupled to the adhesive patch.

[0110] Paragraph B8. The system of any of Paragraphs B1-B7, wherein the anti- gravity system comprises a low-tack adhesive cast on paper coupled between the adhesive patch and the sensor inserter.

[0111] Paragraph B9. A system for deploying a physiological property sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological property sensor, the adhesive patch coupling the physiological property sensor to an anatomical structure; and

[0112] an anti-gravity system coupled to the adhesive patch and the sensor inserter, the anti-gravity system comprising a low-tack adhesive paper having a first surface positioned opposite a second surface by a fold, the first surface coupled to the adhesive patch and the second surface coupled to the sensor inserter, and the anti-gravity system maintaining the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor, and the anti-gravity system removable from the sensor inserter by the adhesive patch upon deployment of the physiological property sensor.

[0113] Paragraph B10. The system of paragraph B1, wherein the anti-gravity system defines a hole through the first surface and the second surface to enable the anti-gravity system to be positioned around a perimeter of the physiological property sensor.

[0114] Paragraph B11. The system of paragraph B10, wherein the anti-gravity system includes a first end opposite a second end, wherein the fold is at the first end, and the anti-gravity system includes a slit at the first end that extends through the fold to enable the anti-gravity system to be removed from the adhesive patch after deployment.

[0115] Paragraph B12. The system of paragraph B11, wherein the anti-gravity system extends a first distance at the first end and a second distance at the second end, the first distance being different than the second distance.

Claims

1. A system for deploying a physiological property sensor through a sensor inserter, the system comprising: an adhesive patch having a first face secured to the physiological property sensor and a second face to adhere to an anatomical structure to secure the physiological property sensor to the anatomical structure, wherein the adhesive patch has a peripheral region radially outward relative to the physiological property sensor; and an anti-gravity system coupled to the adhesive patch in the peripheral region of the first face and to be coupled to the sensor inserter, the anti-gravity system configured to maintain the peripheral region of the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological property sensor and to detach from one or both of the adhesive patch and the sensor inserter upon deployment of the physiological property sensor, wherein the anti-gravity system comprises at least one adhesive layer coupled to the first face of the adhesive patch in the peripheral region and to be coupled to a surface of the sensor inserter, wherein the at least one adhesive layer comprises a first tacky adhesive on a first side and a second tacky adhesive on an opposite side, the second tacky adhesive having a tack less than a tack of the first tacky adhesive.

2. The system of claim 1, wherein the at least one adhesive layer comprises a plurality of adhesive strips spaced around the peripheral region of the adhesive patch.

3. The system of claim 1, wherein the anti-gravity system comprises a plurality of adhesive layers coupled between the first face of the adhesive patch and to be coupled to a surface of the sensor inserter.

4. The system of claim 3, wherein a first adhesive layer of the plurality of adhesive layers comprises a first tacky adhesive on opposite sides and a second adhesive layer of the plurality of adhesive layers comprises a second tacky adhesive on opposite sides, the second tacky adhesive having a tack less than a tack of the first tacky adhesive.

5. The system of claim 1 or 4, wherein the first tacky adhesive is to be coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

6. The system of claim 1, wherein the adhesive patch includes a first charged surface having a first charge, the sensor inserter includes a second charged surface having a second charge, and the first charge interacts with the second charge to exert a force on the adhesive patch to maintain the adhesive patch perpendicular to the longitudinal axis of the sensor inserter.

7. The system of claim 1, wherein the anti-gravity system comprises a layered sheet (112a) having a low tack adhesive on one side and folded to form two layers (140, 142) joined at a fold (144) with the adhesive facing outward, the sheet (112a) having a hole through both layers (140, 142) for the physiological property sensor, wherein one layer (142) is adhered to the perimeter region of the adhesive patch and the other layer (140) is to be adhered to the sensor inserter.

8. The system of claim 7, wherein the anti-gravity system includes a slit at a first end that extends through the fold (144) to facilitate removal of the anti-gravity system from the adhesive patch after deployment.

9. The system of claim 8, wherein the anti-gravity system extends a first distance at the first end and a second distance at a second end opposite the first end, the first distance being different than the second distance.

10. The system of any of claims 7-9, wherein the layered sheet (112a) is paper, polyester film, or HDPE film.

11. The system of claim 10, wherein the layered sheet (112a) is polycoated paper.

12. A patch-mounted medical device for deployment by an inserter, the patch-mounted medical device comprising: the medical device; an adhesive patch having a first face secured to the medical device and a second face to be adhered to an anatomical structure, wherein the adhesive patch has a perimeter region radially outward relative to the medical device; an anti-gravity system coupled to the adhesive patch in the perimeter region of the first face and to be coupled to the inserter, the anti-gravity system configured to maintain the perimeter region of the adhesive patch substantially perpendicular to a longitudinal axis of the inserter prior to deployment of the medical device and to separate from one or both of the adhesive patch and the inserter upon deployment of the medical device; and a double-sided adhesive spacer adhered to the first face of the adhesive patch in the perimeter region and to be coupled to a surface of the inserter, wherein the double-sided adhesive spacer comprises a first tacky adhesive on a first side adhered to the first face of the adhesive patch and a second tacky adhesive on an opposite side, the second tacky adhesive having a tack less than a tack of the first tacky adhesive. ​

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