CN114929106A - Anti-gravity system for skin patch - Google Patents

Abstract

A system for a physiological characteristic sensor deployed with a sensor inserter includes an adhesive skin patch coupled to the physiological characteristic 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 the 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

Anti-gravity system of skin patch

Technical Field

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 present subject matter relate to systems that improve the antigravity force of a dermal patch during storage to ensure that the dermal patch remains ready to be coupled to a user after a period of time.

Background

Sensors can be employed to treat or monitor various medical conditions in one example, thin film electrochemical sensors are used to test a patient or user for analyte levels. More specifically, thin film sensors have been designed for obtaining an indication of Blood Glucose (BG) levels of a diabetic user and monitoring BG levels, with a distal section portion of the sensor positioned subcutaneously in direct contact with extracellular fluid. Such readings may be particularly useful for adjusting a treatment regimen that typically includes regular administration of insulin to a user.

Glucose sensors of the type described above may be packaged and sold as a product, such as a continuous glucose monitor, which is adhered to a patient during use by an adhesive skin patch. In some cases, the continuous glucose monitor may be packaged with a sensor introducer tool, which enables subcutaneous/percutaneous implantation of the glucose sensor. The sensor introducer tool contains a needle for piercing the skin of the user while introducing the sensor. The needle is then withdrawn, leaving the sensor in the skin of the user.

Where the continuous glucose sensor is packaged with the sensor introducer tool, the continuous glucose sensor may be positioned within the sensor introducer tool such that the skin patch is subjected to the influence of gravity. When gravity acts on the skin patch, it may cause the skin patch to sag or sag within the sensor introducer tool. When this happens, the skin patch, in particular its peripheral region, will no longer lie perpendicular to the longitudinal axis of the introducer tool. When the skin patch sags or sags within the sensor introducer tool, the skin patch may fold over on itself and thus may not adhere well to the user when the tool is actuated.

Accordingly, it is desirable to provide a system for improving the antigravity of a skin patch, such as a skin patch coupled to a physiological characteristic sensor (e.g., a glucose sensor or continuous glucose monitor), that inhibits sagging or sagging of the skin patch to ensure that the skin patch remains ready for coupling to a user after a period of time. Furthermore, 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.

Disclosure of Invention

The technology of the present disclosure relates generally to systems that improve the antigravity of an adhesive skin patch (e.g., an adhesive skin patch coupled to a medical device, such as a glucose sensor or continuous glucose monitor).

A system for a physiological characteristic sensor deployed with a sensor inserter is provided according to various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. An adhesive patch couples the physiological characteristic sensor to the 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 perpendicular to the longitudinal axis of the sensor inserter prior to deployment of the physiological characteristic sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological characteristic sensor.

A system for deploying a physiological characteristic sensor with a sensor inserter is also provided. The system includes an adhesive patch coupled to the physiological property sensor. An adhesive patch couples the physiological property sensor to the anatomical structure. The system includes an anti-gravity system coupled to the adhesive patch and the sensor inserter. The anti-gravity system includes at least one adhesive layer coupled between the adhesive patch and the sensor interposer. The at least one adhesive layer is 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. The anti-gravity system maintains the adhesive patch substantially perpendicular to the 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.

Further provided is a system for deploying a physiological characteristic sensor with a sensor inserter. The system includes an adhesive patch coupled to the physiological property sensor. An adhesive patch couples the physiological property sensor to the anatomical structure. The system includes an anti-gravity system coupled to the adhesive patch and the sensor inserter. The anti-gravity system includes at least one adhesive layer coupled between the adhesive patch and the sensor interposer. The at least one adhesive layer is 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 comprises a first tacky adhesive on a first side and a second tacky adhesive on an opposite side, and the tack of the second tacky adhesive is less than the tack of the first tacky adhesive. The anti-gravity system maintains the adhesive patch substantially perpendicular to the 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.

A system for a physiological characteristic sensor deployed with a sensor inserter is also provided according to various embodiments. The system includes an adhesive patch coupled to the physiological property sensor. An adhesive patch couples the physiological property sensor to the 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 the 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 through the adhesive patch upon deployment of the physiological property sensor.

Further provided is a system for deploying a physiological characteristic sensor with a sensor inserter. The system includes an adhesive patch coupled to the physiological property sensor. An adhesive patch couples the physiological characteristic sensor to the anatomical structure. The system includes an anti-gravity system coupled to the adhesive patch and the sensor inserter. The antigravity system comprises a low tack adhesive paper having a first layer/surface positioned opposite a second layer/surface by folding. The first layer/surface is coupled to the adhesive patch and the second layer/surface is coupled to the sensor interposer. The anti-gravity system maintains the adhesive patch substantially perpendicular to the longitudinal axis of the sensor inserter prior to deployment of the physiological characteristic sensor, and the anti-gravity system is removable from the sensor inserter through the adhesive patch upon deployment of the physiological characteristic sensor.

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 as an aid in determining the scope of the claimed subject matter. The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in the disclosure will be apparent from the description and drawings, and from the claims.

Drawings

A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.

FIG. 1 is a perspective view of an exemplary sensor introduction system including a sensor inserter and a physiological characteristic sensor assembly having an exemplary anti-gravity system according to various teachings of the present disclosure;

FIG. 2 is a cross-sectional view of the sensor introduction system of FIG. 1 taken along line 2-2 of FIG. 1;

FIG. 3 is a top view of a physiological property sensor assembly including the exemplary anti-gravity system of FIG. 1;

FIG. 4 is a side view of a physiological characteristic sensor assembly including the exemplary anti-gravity system of FIG. 1;

FIG. 5 is a cross-sectional view of another exemplary sensor introduction system including a sensor inserter and a physiological characteristic sensor assembly with an exemplary antigravity system according to various teachings of the present disclosure, taken from a perspective view of line 2-2 of FIG. 1;

FIG. 6 is a top view of a physiological characteristic sensor assembly including the exemplary anti-gravity system of FIG. 5;

FIG. 7 is a cross-sectional view of a physiological characteristic sensor assembly including the exemplary anti-gravity system of FIG. 6, taken along line 7-7 of FIG. 6;

FIG. 8 is a bottom view of a physiological property sensor assembly including the exemplary anti-gravity system of FIG. 5 with an adhesive patch associated with the physiological property sensor assembly removed for clarity;

FIG. 9 is a cross-sectional view of another exemplary sensor introduction system including a sensor inserter and a physiological property sensor assembly having an exemplary anti-gravity system according to various teachings of the present disclosure taken from a perspective view of line 2-2 of FIG. 1;

FIG. 10 is a top view of a physiological property sensor assembly including the exemplary anti-gravity system of FIG. 9;

FIG. 11 is a cross-sectional view of a physiological characteristic sensor assembly including the exemplary anti-gravity system of FIG. 10 taken along line 11-11 of FIG. 10;

FIG. 12 is a cross-sectional view of another exemplary sensor introduction system including a sensor inserter and a physiological property sensor assembly having an exemplary anti-gravity system according to various teachings of the present disclosure taken from a perspective view of line 2-2 of FIG. 1;

FIG. 13 is a top view of a physiological property sensor assembly including the exemplary anti-gravity system of FIG. 12;

FIG. 14 is a cross-sectional view of a physiological characteristic sensor assembly including the exemplary anti-gravity system of FIG. 13 taken along line 14-14 of FIG. 13; and

fig. 15 is a cross-sectional view of another exemplary sensor introduction system including a sensor inserter and a physiological property sensor assembly having an exemplary antigravity system according to various teachings of the present disclosure, taken from a perspective view of line 2-2 of fig. 1.

Detailed Description

The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration" any embodiment described herein as exemplary is not necessarily to be construed as preferred or advantageous over other embodiments. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

Certain terminology may be used in the following description for reference purposes only and is therefore not intended to be limiting. Certain terminology may be used in the following description for reference purposes only, and thus these terms are not intended to be limiting. Terms such as "front," "back," "rear," "side," "outboard," and "inboard" may be used to describe the orientation and/or position of various portions of the component within a consistent but arbitrary frame of reference as may be apparent by reference to the text and associated drawings describing the component in question. Such terms may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms "first," "second," and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context

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

The following description relates to various embodiments for an adhesive skin patch anti-gravity system. For example, the system described herein inhibits or mitigates the effects of gravity on the adhesive dermal patch during storage, which ensures proper adhesion of the dermal patch to the user. It should be noted that while the adhesive skin patch described herein is used with a glucose sensor, such as a glucose sensor associated with a continuous glucose monitor, it should be understood that the adhesive skin patch may be used with a variety of other sensors (e.g., a heart monitor, a body temperature sensor, an EKG monitor, 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 so limited.

Typically, 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 may not be described in detail herein. In this regard, known and/or conventional aspects of glucose sensors and their manufacture may be, but are not limited to, the types described below: 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).

Referring to fig. 1, fig. 1 is a perspective view of a sensor lead-in assembly 100. In one example, the sensor lead-in assembly 100 includes a physiological characteristic 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 may comprise an insertion device and sensor emitter assembly as 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, with additional reference to fig. 2, the physiological characteristic sensor assembly 102 includes a physiological characteristic sensor 108, an adhesive skin patch or adhesive patch 110, and an anti-gravity system 112. Typically, the components of the physiological characteristic sensor assembly 102 are coupled together as a single unit. The physiological characteristic sensor assembly 102 and the sensor inserter 104 may be packaged together for consumer use.

Certain features, aspects, and characteristics of the sensor inserter 104, the physiological characteristic sensor 108, and the adhesive patch 110 may be conventional and therefore will not be described in detail herein. Briefly, the physiological characteristic sensor 108 may be pre-connected as part of a sensor group that may also include a sensor electronics module (not shown), such as a wireless transmitter in communication with an infusion pump, monitor device, or the like, that is connected to the physiological characteristic sensor 108 after part of the physiological characteristic sensor 108 is inserted or deployed in the body of the user. In one example, physiological characteristic sensor 108 includes a glucose sensor 122 and a sensor base 124. It should be noted that the physiological characteristic sensor 108 is not limited to a glucose sensor, but various other physiological characteristic sensors may be employed. The glucose sensor 122 may be provided as an integral part of a sensor base 124. Sensor base 124 gives glucose sensor 122 structural support and facilitates entry of 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. Glucose oxidase enables the glucose sensor 122 to monitor the blood glucose level of a diabetic patient or user by carrying out the reaction of glucose and oxygen. Also, although certain embodiments relate to glucose sensors, the techniques described herein may be adapted for use with any of a variety of sensors known in the art. Generally, the glucose sensor 122 may be positioned in the subcutaneous tissue of the user through the insertion needle 126 of the sensor inserter 104 to measure glucose oxidase.

The sensor base 124 is coupled to the sensor inserter 104 and to the adhesive patch 110. The sensor base 124 is removably coupled to the sensor inserter 104. The sensor base 124 may also feature electrical and physical interfaces and elements that house a sensor electronics module, such as a wireless transmitter that communicates with an infusion pump, monitor device, or the like. In certain embodiments, the sensor base 124 is at least partially constructed of a plastic material for the embodiments described herein, a majority of the sensor base 124 is formed as a molded plastic component. In one example, the sensor base 124 is formed from acrylonitrile butadiene styrene, nylon, acrylonitrile butadiene styrene polycarbonate blends, polyvinyl chloride, Polytetrafluoroethylene (PTFE), polypropylene, Polyetheretherketone (PEEK), polycarbonate, and the like.

Adhesive patch 110 is coupled to sensor base 124 and secures sensor base 124, and thus 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 gravity G. Adhesive patch 110 may be constructed of a flexible, breathable material, such as cloth, a bandage-like material, or the like, having one or more adhesive layers. For example, suitable materials may include polyurethane, polyethylene, polyester, polypropylene, Polytetrafluoroethylene (PTFE), or other polymers, with one or more adhesive layers applied thereto.

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 fig. 2, the sensor inserter 104 includes a housing 130, a stand or monitor support 132, one or more biasing members or springs 134, and a cover or shield 136. For example, in one example, the housing 130 surrounds the physiological property sensor assembly 102 and encloses the physiological property sensor assembly 102 to enable sterilization of the physiological property sensor assembly 102. The housing 130 may include one or more features, such as movable tabs, that cooperate with the monitor support 132 to deploy the physiological property sensor 108 into the 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 the anatomical structure. For example, the force applied to the housing 130 can bias the protrusion to release the monitor support 132 such that the spring 134 associated with the monitor support 132 can drive the monitor support 132 to deploy the physiological property sensor 108 into the anatomical structure. Once released, the other spring 134b cooperates with the monitor support 132 to move the needle retractor 131 relative to the housing 130. A shroud 136 surrounds the circumferential open end of the housing 130 and surrounds the housing 130. Generally, the cover 136 is coupled to the housing 130 such that the adhesive patch 110 is not supported by the cover 136. As will be discussed, the anti-gravity system 112 inhibits or mitigates the gravity G from pulling the unsupported adhesive patch 110 downward, which in turn inhibits or mitigates sagging or sagging of the adhesive patch 110 within the sensor inserter 104, thereby ensuring full contact is made between the entire adhesive patch 110 and the anatomy of the user.

In one example, referring to FIG. 3, the anti-gravity system 112 is shown in greater detail. Fig. 3 is a top view of the physiological property sensor assembly 102 showing 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 that is coupled to the adhesive patch 110 and the monitor support 132 (fig. 2). Antigravity system 112 includes a first top surface 140 and a second bottom surface 142 that are connected to each other at a fold 144 (FIG. 4). Antigravity system 112 is substantially annular and defines an aperture 146 sized to enable antigravity system 112 to be positioned about the periphery of sensor base 124. Typically, anti-gravity system 112 surrounds the entire circumference of sensor base 124 and may include a slot 148. If desired, the slot 148 enables the user to remove the anti-gravity system 112 from the adhesive patch 110 once the physiological property sensor 108 is coupled to the anatomical structure. In this example, a slot 148 is defined at an end 150 of the anti-gravity system 112 that includes the fold 144. The fold 144 may be configured such that the end 150 extends a distance D1 that is different from and less than the distance D2 of the opposite end 152 of the anti-gravity system 112. In this example, the anti-gravity system 112 is coupled to the surface 110a of the adhesive patch 110 along the perimeter 110b of the adhesive patch 110 and extends a distance D3 from the perimeter of the adhesive patch 110 to the sensor base 124. Generally, 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.

In this example, referring to fig. 4, the anti-gravity system 112 is comprised of a layered 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 layered sheet 112a such that, when folded, the top and bottom surfaces 140, 142 include the low tack adhesive 112b and the opposing surface 154 remains uncoated with the low tack adhesive 112 b. In one example, the layered sheet 112a is composed of paper, poly-coated paper, a polymer (e.g., a polyester film or HDPE film), or the like; and the low-tack adhesive 112b is made of silicone, acrylic, or the like. The low tack adhesive 112b may be cast, coated, painted, or otherwise coupled to the layered sheet 112 a. The low tack adhesive 112b along the bottom surface 142 is coupled or adhered to the surface 110a of the adhesive patch 110, while the low tack adhesive 112b along the top surface 140 is coupled or adhered to the surface 132a of the monitor support 132 (fig. 2). As used herein, a "low tack" adhesive is one that has a sufficiently weak bond to allow the adhesive to be easily separated in its intended use (e.g., to separate a liner from an adhesive patch before or after insertion). As used herein, a "high tack" adhesive is one that is intended to be permanently bonded (i.e., without separation). For example, as used herein, a "low tack" adhesive has a peel force adhesion to stainless steel of about 0.5 ounces per inch (oz/in.) to about 5 ounces per inch (oz/in.) according to ASTM D6862-11 standard test method for 90 degrees peel resistance of the adhesive, and a "high tack" adhesive has a peel force adhesion to stainless steel of greater than 5 ounces per inch (oz/in.) according to ASTM D6862-11 standard test method for 90 degrees peel resistance of the adhesive.

In one example, with the physiological property sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 112, the low tack adhesive 112b on the bottom surface 142 is coupled to the adhesive patch 110 so as to surround the sensor base 124. The top surface 140 is folded over the bottom surface 142 at a fold 144. Referring to fig. 3, with the physiological property sensor assembly 102 assembled and the spring 134 and monitor support 132 coupled to the housing 130, the physiological property sensor assembly 102 is coupled to the sensor inserter 104 such that the low tack adhesive 112b is coupled to the surface 132a of the monitor support 132. With the physiological characteristic sensor assembly 102 coupled to the monitor support 132, the shroud 136 is coupled to the housing 130 to enclose the physiological characteristic sensor assembly 102. The sensor inserter 104 including the physiological characteristic sensor assembly 102 may be sterilized and shipped to the end user.

Once received, the user may remove the cover 136 to expose the physiological property sensor assembly 102. The user may operate the sensor inserter 104 to deploy the physiological characteristic sensor assembly 102 to the user. Once deployed, the low tack adhesive 112b on the top surface 140 enables the sensor inserter 104 to be removed from the physiological property sensor assembly 102 without decoupling the adhesive patch 110 from the user. With the sensor inserter 104 uncoupled from the physiological characteristic sensor assembly 102 and the physiological characteristic sensor assembly 102 deployed on the user, the user can pull the top surface 140 of the anti-gravity system 112 to remove the anti-gravity system 112 from the adhesive patch 110, if desired.

By providing the low tack adhesive 112b on the top surface 140, the sensor inserter 104 may be removed from the physiological property sensor 108 upon deployment without removing the adhesive patch 110 from the user. Thus, when deploying the physiological property sensor 108, the anti-gravity system 112 may be removed from the sensor inserter 104 by the adhesive patch 110. In addition, 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 (fig. 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. The fold 144 also allows the user to remove the anti-gravity system 112 when deployed, if desired.

It should be noted that in other embodiments, the anti-gravity system 112 may be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, referring to fig. 5, a sensor lead-in 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 fig. 1-4, the same reference numerals will be used to identify the same or similar components. Fig. 5 is a schematic cross-sectional view taken from the perspective of line 2-2 of fig. 1. In this example, the sensor introduction assembly 200 includes a physiological characteristic 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 the anti-gravity system 212. Typically, the components of the physiological characteristic sensor assembly 102 are coupled together as a single unit. The physiological characteristic sensor assembly 202 and the sensor inserter 204 may be packaged together for use by a consumer.

Physiological characteristic sensor 108 includes a glucose sensor 122 and a sensor base 124. Generally, the glucose sensor 122 may be positioned in the subcutaneous tissue of the user through the 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. Adhesive patch 110 is coupled to sensor base 124 and affixes sensor base 124, and thus 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 gravity G.

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 shroud 236. For example, in one example, the housing 230 surrounds the physiological property sensor assembly 202 and encloses the physiological property sensor assembly 202 to enable sterilization of the physiological property sensor assembly 202. The housing 230 may include one or more features that cooperate with the monitor support 232 to deploy the physiological property sensor 108 into the anatomical structure. The monitor support 232 is coupled to the physiological characteristic sensor 108 and is operated by a user to deploy the physiological characteristic sensor 108. A shroud 236 surrounds the circumferential open end of the housing 230 and surrounds the housing 230. Typically, the cover 236 is coupled to the housing 230 such that the adhesive patch 110 is not supported by the cover 236. As will be discussed, the anti-gravity system 212 inhibits or mitigates the gravity G from pulling the unsupported adhesive patch 110 downward, which in turn inhibits or mitigates sagging or sagging of the adhesive patch 110 within the sensor inserter 104, thereby ensuring full contact is made between the entire adhesive patch 110 and the anatomy of the user.

In one example, referring to fig. 6, the anti-gravity system 212 is shown in greater detail. Fig. 6 is a top view of the physiological property sensor assembly 202 depicting the anti-gravity system 212 coupled to the adhesive patch 110. Referring to fig. 6 and 8, the anti-gravity system 212 includes a first top surface 240 and a second bottom surface 242 (fig. 8). In fig. 8, the adhesive patch 110 is removed for clarity. Antigravity system 212 is substantially annular and defines an aperture 246 that is sized to enable antigravity system 212 to be positioned about the periphery of sensor base 124. Typically, the anti-gravity system 212 surrounds the entire circumference of the sensor base 124. In this example, referring to fig. 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 toward 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.

In this example, 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. A high tack adhesive layer 250 is coupled to the monitor support 232 (fig. 5), and a low tack adhesive layer 252 is coupled to the adhesive patch 110. In this example, a high tack adhesive 250a is coupled to or formed on the opposite side of the base layer. The base layer is made of paper, poly-coated paper, a polymer (e.g., a polyester film or a HDPE film), or the like. The top surface 240 of the anti-gravity system 212 is defined by one side 250b of a high tack adhesive layer 250 that 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 may 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.

In this example, a low tack adhesive 252a is coupled to or formed on the opposite side of the second base layer. The bottom surface 242 of the anti-gravity system 212 is defined by a side 252b of the low tack adhesive layer 252 that is coupled to or formed on the second base layer. The second base layer is comprised of paper, poly-coated paper, polymer (e.g., polyester film or HDPE film). In one example, the low tack adhesive 252a is composed of silicone, acrylic, or the like. The low tack adhesive 252a may 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 tack adhesive and the low tack adhesive 252a is a second tack adhesive, where the second tack adhesive is different from and smaller than the first tack adhesive. It should be noted that the base layer and the second base layer are not shown in the figures for ease of illustration, as these paper or film layers have a predetermined nominal thickness.

In one example, with the physiological property sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 212, referring to fig. 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 property sensor assembly 202 coupled to the monitor support 232, the shroud 236 is coupled to the housing 230 to enclose the physiological property sensor assembly 202. The sensor inserter 204, including the physiological characteristic sensor assembly 202, may be sterilized and shipped to the end user.

Once received, the user may remove the cover 236 to expose the physiological characteristic sensor assembly 202. The user may operate the sensor inserter 204 to deploy the physiological characteristic 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 removal of the anti-gravity system 212 from the adhesive patch 110 without decoupling the adhesive patch 110 from the user. Thus, the anti-gravity system 212 may be removed from the adhesive patch 110 by the sensor inserter 204 when the physiological characteristic sensor 108 is deployed. The differential adhesive of the anti-gravity system 212 enables the sensor inserter 204 to be decoupled from the physiological property sensor 108 without decoupling the physiological property sensor 108 and the adhesive patch 110 from the user when the physiological property sensor 108 is coupled to the user by the adhesive patch 110.

By providing a high tack adhesive layer 250 on the top surface 240 and a low tack adhesive layer 252 on the bottom surface 242, the anti-gravity system 212 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. In addition, 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 deploying the adhesive patch 110.

It should be noted that in other embodiments, the anti-gravity system 112 may be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, referring to fig. 9, a sensor lead-in assembly 300 is shown. Since the sensor introduction assembly 300 includes the same or similar components as the sensor introduction assembly 100 discussed with respect to fig. 1-4 and the sensor introduction assembly 200 discussed with respect to fig. 5-8, the same reference numerals will be used to designate the same or similar components. Fig. 9 is a schematic cross-sectional view taken from the perspective of line 2-2 of fig. 1. In this example, the sensor introduction assembly 300 includes a physiological characteristic sensor assembly 302 and a sensor inserter 204. In this example, the physiological property sensor assembly 302 includes the physiological property sensor 108, the adhesive patch 110, and the anti-gravity system 312. Typically, the components of the physiological characteristic sensor assembly 302 are coupled together as a single unit. The physiological characteristic sensor assembly 302 and the sensor inserter 204 may be packaged together for consumer use.

The physiological characteristic 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. Adhesive patch 110 is coupled to sensor base 124 and attaches sensor base 124, and thus 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 gravity G.

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 shroud 236. For example, in one example, the housing 230 surrounds the physiological property sensor assembly 302 and encloses the physiological property sensor assembly 302 to enable sterilization of the physiological property sensor assembly 302. The housing 230 may include one or more features that cooperate with the monitor support 232 to deploy the physiological property sensor 108 into the anatomical structure. The monitor support 232 is coupled to the physiological property sensor 108 and is operated by a user to deploy the physiological property sensor 108. A shroud 236 surrounds the circumferential open end of the housing 230 and surrounds the housing 230. Typically, the cover 236 is coupled to the housing 230 such that the adhesive patch 110 is not supported by the cover 236. As will be discussed, the anti-gravity system 312 inhibits or mitigates the force of gravity G from pulling the unsupported adhesive patch 110 downward, which in turn inhibits or mitigates sagging or sagging of the adhesive patch 110 within the sensor inserter 204, thereby ensuring that full contact is made between the entire adhesive patch 110 and the anatomy of the user.

In one example, referring to fig. 10, the anti-gravity system 312 is shown in greater detail. Fig. 10 is a top view of the physiological property sensor assembly 302 depicting the anti-gravity system 312 coupled to the adhesive patch 110. Referring to fig. 10 and 11, anti-gravity system 312 includes a first top surface 340 and a second bottom surface 342 (fig. 11). Antigravity system 312 is substantially annular and defines an aperture 346 sized to enable antigravity system 312 to be positioned about the periphery of sensor base 124 (FIG. 10). Typically, the anti-gravity system 312 surrounds the entire circumference of the sensor base 124. In this example, referring to fig. 11, anti-gravity system 312 is coupled to surface 110a of adhesive patch 110 along perimeter 110b of adhesive patch 110 and extends a distance D7 from the perimeter of adhesive patch 110 toward sensor base 124. Generally, 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.

In this example, the anti-gravity system 312 is a single layer of double-sided differential adhesive that includes a high tack adhesive 350 on the first side 312a and a low tack adhesive 352 on the second side 312 b. A high tack adhesive 350 is coupled to the monitor support 332 (fig. 9), and a 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 the base layer. The base layer is composed of paper, poly-coated paper, polymers (e.g., polyester film or HDPE film). The top surface 340 of the anti-gravity system 312 is defined by a high tack adhesive 350 and the bottom surface 342 of the anti-gravity system 312 is defined by a low tack adhesive 352 that are coupled to or formed on opposite sides of the base layer. In one example, the high tack adhesive 350 is composed of a synthetic rubber adhesive, acrylic, or the like. The high tack adhesive 350 may be cast, coated, painted, or otherwise coupled to the base layer. A low tack adhesive 352 is coupled to or formed on a second, opposite side of the base layer. In one example, the low tack adhesive 352 is composed of silicone, acrylic, or the like. The low tack adhesive 352 may be cast, coated, painted, or otherwise coupled to the base layer. It should be noted that the base layer is not shown in the figures for ease of illustration, as the paper or film layer has a predetermined nominal thickness.

In one example, with the physiological characteristic sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 312, referring to fig. 9, a low tack adhesive 352 on the bottom surface 342 is coupled to the adhesive patch 110 so as to surround the sensor base 124. With the physiological characteristic sensor assembly 302 assembled and the monitor support 232 coupled to the housing 230, the physiological characteristic sensor assembly 302 is coupled to the sensor inserter 204 such that the high tack adhesive 350 is coupled to the surface 232a of the monitor support 232. With the physiological property sensor assembly 302 coupled to the monitor support 232, the shroud 236 is coupled to the housing 230 to enclose the physiological property sensor assembly 302. The sensor inserter 204 including the physiological characteristic sensor assembly 302 may be sterilized and shipped to the end user.

Once received, the user may remove cover 236 to expose physiological property sensor assembly 302. The user may operate the sensor inserter 204 to deploy the physiological characteristic sensor assembly 302 to the user. Once deployed, the high tack adhesive 350 on the top surface 340 retains the anti-gravity system 312 on the sensor inserter 204 and the low tack adhesive 352 is able to remove the anti-gravity system 312 from the adhesive patch 110 without decoupling the adhesive patch 110 from the user. Thus, when the physiological property sensor 108 is coupled to the user by the adhesive patch 110, the differential adhesive of the anti-gravity system 312 enables the sensor inserter 204 to be uncoupled from the physiological property sensor 108 without the need to decouple the physiological property sensor 108 and the adhesive patch 110 from the user.

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 is removable from the physiological characteristic sensor 108 upon deployment without removing the adhesive patch 110 from the user. Thus, the anti-gravity system 312 may be removed from the adhesive patch 110 by the sensor inserter 204 when the physiological characteristic sensor 108 is deployed. In addition, the low tack adhesive 352 on the bottom surface 342 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 312 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 312 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 deploying the adhesive patch 110.

It should be noted that in other embodiments, the anti-gravity system 112 may be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, referring to fig. 12, a sensor lead-in assembly 400 is shown. Since the sensor introduction assembly 400 includes the same or similar components as the sensor introduction assembly 100 discussed with respect to fig. 1-4 and the sensor introduction assembly 200 discussed with respect to fig. 5-8, the same reference numerals will be used to identify the same or similar components. Fig. 12 is a schematic cross-sectional view taken from a perspective view of line 2-2 of fig. 1. 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 property sensor assembly 402 includes the physiological property sensor 108, the adhesive patch 110, and the anti-gravity system 412. Typically, the components of the physiological characteristic sensor assembly 402 are coupled together as a single unit. The physiological characteristic sensor assembly 402 and the sensor inserter 204 may be packaged together for consumer use.

Physiological characteristic 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. Adhesive patch 110 is coupled to sensor base 124 and affixes sensor base 124, and thus 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 gravity G.

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 shroud 236. For example, in one example, the housing 230 surrounds the physiological property sensor assembly 202 and encloses the physiological property sensor assembly 202 to enable sterilization of the physiological property sensor assembly 202. The housing 230 may include one or more features that cooperate with the monitor support 232 to deploy the physiological property sensor 108 into the anatomical structure. The monitor support 232 is coupled to the physiological property sensor 108 and is operated by a user to deploy the physiological property sensor 108 into the anatomy. A shroud 236 surrounds the circumferential open end of the housing 230 and surrounds the housing 230. Typically, the cover 236 is coupled to the housing 230 such that the adhesive patch 110 is not supported by the cover 236. As will be discussed, the anti-gravity system 412 inhibits or mitigates the gravity G from pulling the unsupported adhesive patch 110 downward, which in turn inhibits or mitigates sagging or sagging of the adhesive patch 110 within the sensor inserter 204, thereby ensuring full contact is made between the entire adhesive patch 110 and the anatomy of the user.

In one example, referring to fig. 13, the anti-gravity system 412 is shown in greater detail. Fig. 13 is a top view of the physiological property sensor assembly 402 showing the anti-gravity system 412 coupled to the adhesive patch 110. In this example, anti-gravity system 412 includes a plurality of adhesive stripes 414 spaced around the perimeter of sensor base 124. A plurality of adhesive stripes 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 stripes 414, but it should be understood that the anti-gravity system 412 may include any number of adhesive stripes 414.

Each of the adhesive stripes 414 includes a first top surface 440 and a second bottom surface 442 (fig. 14). Each of the adhesive stripes 414 is rectangular with rounded edges. It should be noted, however, that the adhesive stripes 414 may have any desired shape, and further, one or more of the adhesive stripes 414 may have a different shape. In this example, each of the adhesive stripes 414 has a length L1 and a width W1. The length L1 and the width W1 are both predefined to ensure that the adhesive strip 414 provides rigidity to the adhesive patch 110 while also ensuring that the adhesive strip 414 does not interfere with removal of the adhesive patch 110 from the sensor inserter 204, as will be discussed below. In one example, length L1 is about 100 micrometers (μm) to about 1.0 millimeters (mm); and a width W1 of about 100 micrometers (μm) to about 5.0 millimeters (mm). Generally, the adhesive strip 414 is sized and positioned to interface with the monitor support 232. Each of the adhesive stripes 414 is positioned a distance D9 from the perimeter 110b of the adhesive patch 110 and a distance D10 from the perimeter of the sensor base 124. In one example, distance D9 is about equal to or equal to distance D10 and is about 0 millimeters (mm) to about 10 millimeters (mm).

In this example, each of the adhesive stripes 414 comprises 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. A high tack adhesive 450 on the top surface 440 is coupled to the monitor support 232 (fig. 12), and a low tack adhesive 452 on the bottom surface 442 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 the base layer. The base layer is comprised of paper, poly-coated paper, polymers (e.g., polyester film or HDPE film). In one example, the high tack adhesive 450 is composed of a synthetic rubber adhesive, acrylic, or the like. The high tack adhesive 450 may be cast, coated, painted, or otherwise coupled to the base layer. A low tack adhesive 452 is coupled to or formed on a second opposing side of the base layer. In one example, the low tack adhesive 452 is comprised of silicone, acrylic, or the like. The low tack adhesive 452 may be cast, coated, painted, or otherwise coupled to the base layer. It should be noted that the base layer is not shown in the figures for ease of illustration, as the paper or film layer has a predetermined nominal thickness.

In one example, with the physiological characteristic sensor 108 assembled and coupled to the adhesive patch 110 and forming the anti-gravity system 412, referring to fig. 5, the adhesive strips 414 are coupled to the adhesive patch 110 (via the low tack adhesive 452 on the bottom surface 442) so as to be spaced 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 shroud 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 the end user.

Once received, the user may remove cover 236 to expose physiological property sensor assembly 402. The user may operate the sensor inserter 204 to deploy the physiological characteristic sensor assembly 402 to 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 may be removed 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 through the adhesive patch 110, the anti-gravity system 412 enables the sensor inserter 204 to decouple from the physiological characteristic sensor 108 without decoupling the physiological characteristic sensor 108 and the adhesive patch 110 from the user.

By providing the adhesive strip 414 with the high tack adhesive layer 250 on the top surface 440 and the 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 larger adhesive patches 110 while inhibiting sagging of the adhesive patches 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 LA2 of the sensor inserter 204, which ensures proper coupling to the user when deploying the adhesive patch 110.

It should be noted that in other embodiments, the anti-gravity system 112 may be configured differently to inhibit or mitigate the effects of gravity on the adhesive patch 110. For example, referring to fig. 15, a sensor lead-in 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 fig. 1-4 and the sensor introduction assembly 200 discussed with respect to fig. 5-8, the same reference numerals will be used to designate the same or similar components. Fig. 15 is a schematic cross-sectional view taken from the perspective of line 2-2 of fig. 1. In this example, the sensor introduction assembly 500 includes a physiological characteristic 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. Typically, the components of the physiological characteristic sensor assembly 502 are coupled together as a single unit. The physiological characteristic sensor assembly 502 and the sensor inserter 504 may be packaged together for use by a consumer.

Physiological characteristic sensor 108 includes a glucose sensor 122 and a sensor base 124. Typically, the glucose sensor 122 may be positioned in the subcutaneous tissue of the user through 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.

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

The sensor inserter 504 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 504 includes a housing 230, a monitor support 532, and a cover or shroud 236. For example, in one example, the housing 230 surrounds the physiological property sensor assembly 502 and encloses the physiological property sensor assembly 502 to enable sterilization of the physiological property sensor assembly 502. The housing 230 may include one or more features that cooperate with the monitor support 532 to deploy the physiological property sensor 108 into the anatomical structure. The monitor support 532 is coupled to the physiological property sensor 108 and is operated by a user to deploy the physiological property sensor 108 into the anatomy. In this example, the monitor support 532 includes a charged surface or second charged surface 532 a. The second charged surface 532a faces the adhesive patch 110. In one example, the second charged surface 532a has a negative charge that mates with the first charged surface 510a of the adhesive patch 510. The second charged surface 532a may be charged using contact induced charge separation, charge induced charge separation, or the like. For contact induced charge separation, the amount and polarity of the applied charge depends on the material and surface roughness.

In the example of contact induced charge separation, the first charged surface 510a of the adhesive patch 510 is composed of a more negatively charged material (e.g., a polyurethane film) in a triboelectric series. The second charged surface 532a of the monitor support 532 is constructed of a material (e.g., nylon) that is more positive in a triboelectric series than the strip of material of the first charged surface 510a of the adhesive patch 510. The contact between the first charged surface 510a and the second charged surface 532a results in adhesion between the two surfaces 510a, 532a because electrons are exchanged and attracted to each other by the opposite charges accumulated on each surface, which suppresses sagging of the adhesive patch 510. It should be noted that the materials selected herein are merely examples, as any material that is separated from each other along a triboelectric sequence may be used for the adhesive patch 510 and the monitor support 532, as long as contact between the first and second charged surfaces 510a, 532a results in adhesion between the two surfaces 510a, 532a due to electronic exchange and due to attraction of opposing charges that accumulate on the respective surfaces 510a, 532 a. It should be noted that the entirety of the monitor support 532 may be composed of a predetermined material, or only a surface (e.g., the second electrified surface 532a) of the monitor support 532 may be formed of a predetermined material.

In the example of charge-induced charge separation, the first charged surface 510a may initially be composed of a charge neutral material (e.g., polyester that has been electrically grounded to have a net neutral charge). A negatively charged object may be brought into proximity with the first charged surface 510a to induce a positive charge on the first charged surface 510a as the positive charge associated with the first charged surface 510a moves toward the negatively charged object. Similarly, the second charged surface 532a can be composed of an electrically neutral material (e.g., polycarbonate that has been electrically grounded to have a net neutral charge). Positively charged objects may be brought into proximity with the second charged surface 532a to induce negative charges on the second charged surface 532a as negative charges associated with the first charged surface 510a move toward the positively charged objects. When the physiological property 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.

A shroud 236 surrounds the circumferential open end of the housing 230 and surrounds 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 force of gravity G from pulling the unsupported adhesive patch 510 downward, which in turn inhibits or mitigates sagging or sagging of the adhesive patch 510 within the sensor inserter 204, thereby ensuring that full contact is made between the entire adhesive patch 510 and the anatomy of the user.

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

Once received, the user may remove cover 236 to expose physiological characteristic sensor assembly 502. The user may operate the sensor inserter 504 to deploy the physiological characteristic sensor assembly 502 to the user. The weak attractive force between the first charged surface 510a and the second charged surface 532a enables the sensor inserter 504 to be removed from the physiological property 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 the need to decouple the physiological characteristic sensor 108 and the adhesive patch 510 from the user. Further, the anti-gravity system 512 allows for the use of larger adhesive patches 110 while inhibiting sagging of the adhesive patches 510 by providing an attractive force between the first charged surface 510a and the second charged surface 532 a. In this regard, the attractive force between the first charged surface 510a and the second 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 deploying the adhesive patch 510. In other words, the adhesive patch 510 includes a first charged surface or first charged surface 510a having a first charge, in this example a positive charge, the sensor interposer 504 includes a second charged surface or second charged surface 532a having a second charge, in this example a negative charge, and the first charge is different than the second charge to maintain the adhesive patch 510 substantially perpendicular to the longitudinal axis LA5 of the sensor interposer 504.

It should be noted that the sensor inserter 104, 204, 504 described and depicted herein is merely exemplary, as any device may be used with the anti-gravity system 112, 212, 312, 412, 512 to deploy the physiological property sensor 108 into the anatomy. For example, the exemplary sensor inserter may include only monitor supports, such as monitor supports 232, 532, that are manually operated by a user to deploy the physiological property sensor 108 into the anatomical structure. Further, it should be noted that the sensor inserters 204, 504 may comprise the sensor inserter 104 discussed with respect to fig. 1-4 or an insertion device described in commonly assigned U.S. patent publication No. 2017/0290533 to Antonio et al, relevant portions of which were previously incorporated herein by reference.

While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.

It should be understood that the various aspects disclosed herein may be combined in different combinations than those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different order, may be added, merged, or omitted altogether (e.g., all described acts or events may not be necessary for performing the techniques). Additionally, while certain aspects of the disclosure are described as being performed by a single module or unit for clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device. Further embodiments forming part of the present disclosure are set forth in the following paragraphs of group a and group B.

Group A

Paragraph a1. a system for deploying a physiological characteristic 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 characteristic sensor and removable from the adhesive patch by the sensor inserter upon deployment of the physiological characteristic sensor.

Paragraph a2. the system of paragraph a1, wherein the anti-gravity system includes at least one adhesive layer coupled to a surface of the adhesive patch and to be coupled to a surface of the sensor inserter.

Paragraph a3. the system of paragraph a2, wherein the at least one adhesive layer is a differential double-sided adhesive.

Paragraph a4. the system of paragraph a1, a2, or A3, wherein the at least one adhesive layer includes a plurality of adhesive stripes spaced around a perimeter of the adhesive patch.

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 having a tack less than that of the first tacky adhesive.

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.

Paragraph A7. the system of paragraph a1, wherein the anti-gravity system includes a plurality of adhesive layers coupled between a surface of the adhesive patch and a surface to be coupled to the sensor inserter.

Paragraph A8. is the system of paragraph a7, wherein a first adhesive layer of the plurality of adhesive layers comprises a first tacky adhesive on an opposite side and a second adhesive layer of the plurality of adhesive layers comprises a second tacky adhesive on an opposite side, the tackiness of the second tacky adhesive being less than the tackiness of the first tacky adhesive.

Paragraph A9. is 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.

Paragraph a10. the system of paragraph a1, wherein the adhesive patch includes a first charged surface having a first charge, the sensor interposer 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 interposer.

Paragraph a11. a system for deploying a physiological characteristic sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological characteristic sensor, the adhesive patch coupling the physiological characteristic 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.

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 stripes spaced around the perimeter of the adhesive patch.

Paragraph a13. the system of paragraph a11, wherein the at least one adhesive layer is a differential double-sided adhesive layer.

Paragraph a14. the system of paragraph a13, wherein the at least one adhesive layer includes 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 that of the first tacky adhesive, and the first tacky adhesive is coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

Paragraph a15. the system of paragraph a11, wherein the antigravity system includes 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 includes a first tacky adhesive on an opposite side and a second adhesive layer of the plurality of adhesive layers includes a second tacky adhesive on an opposite side, the second tacky adhesive being smaller than the first tacky adhesive, the first tacky adhesive being coupled to the sensor inserter and the second tacky adhesive being coupled to the adhesive patch.

Paragraph a16. a system for deploying a physiological characteristic sensor with a sensor inserter, comprising: an adhesive patch coupled to the physiological characteristic sensor, the adhesive patch coupling the physiological characteristic sensor to an anatomical structure; and an anti-gravity system coupled to the adhesive patch and the sensor inserter, the anti-gravity system comprising at least one adhesive layer coupled between the adhesive patch and the sensor inserter, the at least one adhesive layer is 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 having a tack less than the tack of the first tacky adhesive, and 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 characteristic sensor portion.

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.

Paragraph a18. the system of paragraph a17, wherein the antigravity system includes a plurality of adhesive layers coupled between a surface of the adhesive patch and a surface of the sensor interposer, wherein a first adhesive layer of the plurality of adhesive layers includes the first tacky adhesive defining the first side and a second adhesive layer of the plurality of adhesive layers includes the second tacky adhesive defining the second side.

Group B

Paragraph b1. a system for a physiological characteristic sensor deployed 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 characteristic sensor, and the anti-gravity system being removable from the sensor inserter through the adhesive patch upon deployment of the physiological characteristic sensor.

Paragraph B2. the system of paragraph B1, wherein the anti-gravity system includes an adhesive paper coupled between the adhesive patch and the sensor inserter.

Paragraph B3. the system of paragraph B1 or B2, wherein the anti-gravity system comprises a first surface opposite a second surface and defines an aperture through the first and second surfaces to enable the anti-gravity system to be positioned around a perimeter of the physiological property sensor.

Paragraph B4. is the system of paragraph B3, wherein the antigravity system includes a first end opposite a second end, and the antigravity system includes a fold at the first end to define the first surface by positioning the first surface over the second surface.

Paragraph B5. is the system of paragraph B4, wherein the anti-gravity system includes a slit at the first end that extends through the fold to enable removal of the anti-gravity system from the adhesive patch after deployment.

Paragraph B6. of paragraph B4, wherein the antigravity 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.

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.

Paragraph B8. of any one 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.

Paragraph B9. a system for deploying a physiological characteristic 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 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 characteristic sensor, and the anti-gravity system being removable from the sensor inserter through the adhesive patch upon deployment of the physiological characteristic sensor.

Paragraph B10. the system of paragraph B1, wherein the anti-gravity system defines an aperture through the first and second surfaces to enable the anti-gravity system to be positioned around a perimeter of the physiological property sensor.

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 such that the anti-gravity system is removed from the adhesive patch after deployment.

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 (15)

1. A system for deploying a physiological characteristic sensor with a sensor inserter, comprising:

an adhesive patch having a first face secured to the physiological property sensor and a second face adhered 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 characteristic sensor and separate from one or both of the adhesive patch and the sensor inserter upon deployment of the physiological characteristic sensor.

2. The system of claim 1, 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 interposer.

3. The system of claim 2, wherein the at least one adhesive layer includes a plurality of adhesive stripes spaced around the peripheral region of the adhesive patch.

4. The system of claim 2 or 3, 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.

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

6. The system of claim 5, wherein a first adhesive layer of the plurality of adhesive layers comprises a first tacky adhesive on an opposing side and a second adhesive layer of the plurality of adhesive layers comprises a second tacky adhesive on an opposing side, the second tacky adhesive having a tack less than a tack of the first tacky adhesive.

7. The system of claim 4 or 6, wherein the first tacky adhesive is to be coupled to the sensor inserter and the second tacky adhesive is coupled to the adhesive patch.

8. The system of claim 1, wherein the adhesive patch includes a first charged surface having a first charge, the sensor interposer 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 interposer.

9. The system of claim 1, wherein the anti-gravity system comprises a laminar 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 an aperture for the physiological property sensor through both layers (140, 142), with one layer (142) adhered to the peripheral region of the adhesive patch and the other layer (140) to be adhered to the sensor inserter.

10. The system as recited in claim 9, 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.

11. The system of claim 10, wherein the antigravity 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.

12. The system of any one of claims 9, 10, or 11, wherein the layered sheet (112a) is paper, poly-coated paper, polyester film, or HDPE film.

13. A method of reducing sagging or sagging of a peripheral region of a skin patch carrying a medical device when stored in an inserter tool prior to deployment by adhering the peripheral region of the patch to the tool using a low tack adhesive that detaches when the tool is activated.

14. A method of reducing sagging or sagging of a peripheral region of a skin patch carrying a medical device when stored in an inserter tool prior to deployment by adhering the peripheral region of the patch to the tool using an electrostatic charge weak enough to cause the patch to separate when the tool is activated.

15. A patch-mounted medical device for deployment with an inserter, comprising:

the medical device;

an adhesive patch having a first face secured to the medical device and a second face adhered to an anatomical structure, wherein the adhesive patch has a peripheral region radially outward relative to a physiological characteristic sensor; and

a double-sided adhesive spacer adhered to the first side of the adhesive patch in the peripheral region.

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