US-12616395-B2 - Systems, devices, and methods for assembling an applicator and sensor control device

US12616395B2US 12616395 B2US12616395 B2US 12616395B2US-12616395-B2

Abstract

Systems, devices, and methods are provided for the assembly and subsequent delivery of an in vivo analyte sensor. An applicator with sensor electronics is inserted into a tray containing an assembly that includes a sharp and an analyte sensor. The insertion causes the assembly to couple with the sensor electronics and form a deliverable sensor control device retained within the applicator, which can then be placed in position on a body of a user to monitor that user's analyte levels.

Inventors

Vivek Rao
Tuan Nguyen

Assignees

ABBOTT DIABETES CARE INC.

Dates

Publication Date: 20260505
Application Date: 20190103

Claims (15)

1 . An in vivo analyte monitoring system, comprising: a sensor control device configured to monitor an in vivo analyte level of a user, the sensor control device comprising: a first engagement member; an in vivo analyte sensor, a distal portion of which is configured to be positioned under a skin surface of the user and in contact with a bodily fluid of the user; an electronics housing; and sensor electronics disposed within the electronics housing and electrically coupled with a proximal portion of the in vivo analyte sensor; and an applicator configured to apply the sensor control device to the body of the user, the applicator comprising: a deflectable arm having a second engagement member configured to engage with the first engagement member, wherein one of the first and second engagement members comprises an at least partially conical projecting surface, wherein the at least partially conical projecting surface comprises a distal edge, and wherein the distal edge is not perpendicular to a direction of axial movement of the sensor control device with respect to the applicator.
2 . The system of claim 1 , wherein the second engagement member comprises the at least partially conical projecting surface and the first engagement member comprises a complementary recess.
3 . The system of claim 2 , wherein the at least partially conical projecting surface slopes away from an interior surface of the deflectable arm such that a proximal terminus of the at least partially conical projecting surface is closer to the interior surface than a point along the distal edge of the at least partially conical projecting surface, wherein the proximal terminus is relatively farther from a body attachment surface of the sensor control device than the distal edge.
4 . The system of claim 2 , wherein the sensor control device comprises a gap or groove proximal to the complementary recess.
5 . The system of claim 4 , wherein the distal edge is not perpendicular with a longitudinal axis of the gap or groove.
6 . The system of claim 5 , wherein the distal edge is configured to slide across the gap or groove without catching the gap or groove as the applicator is withdrawn from the body of the user.
7 . The system of claim 1 , wherein the direction of axial movement is between a proximal location and a distal location.
8 . The system of claim 1 , wherein the deflectable arm is a first deflectable arm, wherein the applicator further comprises a plurality of deflectable arms including the first deflectable arm, wherein each deflectable arm of the plurality of deflectable arms comprises a corresponding engagement member that comprises a corresponding at least partially conical projecting surface, and wherein the sensor control device comprises a plurality of complementary recesses, wherein each complementary recess of the plurality of complementary recesses is configured to engage with a corresponding engagement member of the corresponding engagement members.
9 . The system of claim 1 , wherein an angle between the distal edge and the direction of axial movement of the sensor control device with respect to the applicator is approximately 45 degrees.
10 . The system of claim 1 , wherein an angle between the distal edge and the direction of axial movement of the sensor control device with respect to the applicator is less than 90 degrees.
11 . The system of claim 1 , wherein the in vivo analyte monitoring system is a glucose monitoring system, and wherein the in vivo analyte level of the user is a glucose level of the user.
12 . The system of claim 1 , wherein the applicator further comprises an electronics housing carrier having a plurality of deflectable arms, and wherein the deflectable arm is a first deflectable arm of the plurality of deflectable arms.
13 . The system of claim 1 , wherein the sensor control device is configured to be advanced from a proximal position entirely within the applicator to a distal position in the direction of axial movement.
14 . The system of claim 1 , wherein the sensor control device is further configured to communicate with a reader device over a wireless communication path according to a wireless communication protocol.
15 . The system of claim 1 , wherein the in-vivo analyte sensor is coupled with an application specific integrated circuit.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 15/154,329, filed May 13, 2016, which claims priority to and the benefit of U.S. Provisional Application Ser. No. 62/161,778, filed May 14, 2015, U.S. Provisional Application Ser. No. 62/199,912, filed Jul. 31, 2015, and U.S. Provisional Application Ser. No. 62/203,565, filed Aug. 11, 2015, all of which are incorporated by reference herein in their entireties for all purposes. FIELD The subject matter described herein relates generally to systems, devices, and methods for assembling an applicator and sensor control device for use in an in vivo analyte monitoring system. BACKGROUND Diabetes is a metabolic disease which relates to high blood sugar levels in the body and can be a result of the pancreas failing to produce enough insulin or cells in the body responding improperly to insulin produced. Numerous complications can arise if symptoms of diabetes are not carefully monitored and treated include diabetic ketoacidosis, nonketotick hypersmolar coma, cardiovascular disease, stroke, kindey failure, foot ulcers, eye damage and others. Traditionally, monitoring has involved an individual pricking a finger to draw blood and testing the blood for glucose levels. More recent advancements have allowed for long-term monitoring of blood glucose using sensors which are maintained in the body for periods of days, weeks, or longer. Long-term monitoring of analytes in bodily fluid can be accomplished when a user assembles a sterile sensor control device with an applicator or insertion mechanism and inserts a sensor of the device into contact with a bodily fluid. While current sensors can be convenient for users, they can suffer from user errors which cause malfunctions. These malfunctions can be caused by improper use due to accidents, lack of education, poor coordination, complicated procedures and other issues. Some prior art systems suffer by relying too much on the precision assembly of a sensor control device and an applicator by the user, prior to actually deploying the sensor control device on the user's body. Thus, needs exist for more reliable sensor application devices that are easy to use by the patient. SUMMARY Provided herein are example embodiments of systems, devices and methods for assembling an applicator and a sensor control device. An applicator can be provided to the user in a sterile package with an electronics housing of the sensor control device contained therein. A structure separate from the applicator, such as a container, can also be provided to the user as a sterile package with a sensor module and a sharp module contained therein. The user can couple the sensor module to the electronics housing and can couple the sharp to the applicator with an assembly process that involves insertion of the applicator into the container in a specified manner. The embodiments provided herein are improved to prevent or reduce the negative impact of the applicator tilting with respect to the container during a sensor assembly process. Other improvements and advantages are provided as well. The embodiments described herein can make the assembly process more reliable and easier to complete by the user. After assembly, the applicator can be used to position the sensor control device on a human body with a sensor in contact with the wearer's bodily fluid (e.g., interstitial fluid, dermal fluid, blood, etc.). The various configurations of these devices and variations to the assembly methods are described in detail by way of the embodiments which are only examples. Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims. BRIEF DESCRIPTION OF THE FIGURES The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. FIG. 1 is a system overview of a sensor applicator, reader device, monitoring system, network and remote system. FIG. 2A is a block diagram depicting an example embodiment of a reader dev