US-12616397-B2 - Analyte sensor devices, connections, and methods

US12616397B2US 12616397 B2US12616397 B2US 12616397B2US-12616397-B2

Abstract

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

Inventors

Louis Pace
Marc Barry Taub
Peter G. Robinson
Udo Hoss
Samuel Mason Curry
Phillip William Carter
Vincent Michael DiPalma
Amit Mhatre
Jennifer Olson
Manuel Luis Miguel Donnay

Assignees

ABBOTT DIABETES CARE INC.

Dates

Publication Date: 20260505
Application Date: 20220316

Claims (15)

1 . A glucose sensor insertion assembly, comprising: (1) an applicator assembly comprising a housing, an interior, and a distal end; (2) a sensor electronics assembly releasably retained within the interior of the applicator assembly, the sensor electronics assembly comprising sensor electronics comprising a processor a wireless communications facility, a battery, and a printed circuit board, wherein the wireless communications facility is configured to communicate data indicative of a glucose level to a receiver unit, the sensor electronics disposed within a housing of the sensor electronics assembly, wherein the sensor electronics are configured to electrically couple with a proximal portion of a glucose sensor; and (3) a removable cap configured to be threadably engaged with the distal end of the applicator assembly, wherein the housing of the applicator assembly comprises integrally formed grip features, wherein an end of the removable cap comprises one or more openings configured for passage of a sterilizing gas, wherein the one or more openings are covered by a gas-permeable seal, wherein the sterilizing gas is ethylene oxide, wherein the gas-permeable seal is configured to permit the passage of the ethylene oxide, and wherein the interior of the applicator assembly comprises a sterile environment when the removable cap is threadably engaged with the distal end of the applicator assembly.
2 . The glucose sensor insertion assembly of claim 1 , wherein the gas-permeable seal comprises a sterile barrier material.
3 . The glucose sensor insertion assembly of claim 2 , wherein the gas-permeable seal forms a sterile barrier between an interior of the applicator assembly and an exterior of the glucose sensor insertion assembly.
4 . The glucose sensor insertion assembly of claim 3 , wherein the gas-permeable seal comprises a Tyvek material.
5 . The glucose sensor insertion assembly of claim 1 , further comprising an adhesive patch.
6 . The glucose sensor insertion assembly of claim 5 , wherein the ethylene oxide is compatible with the sensor electronics disposed within the housing of the sensor electronics assembly and the adhesive patch.
7 . The glucose sensor insertion assembly of claim 6 , wherein the removable cap comprises a plurality of threads configured for coupling with a complimentary plurality of threads of the applicator assembly.
8 . The glucose sensor insertion assembly of claim 7 , further comprising the glucose sensor, wherein the glucose sensor comprises a distal portion configured to be positioned under a skin surface and in contact with a bodily fluid of a subject.
9 . The glucose sensor insertion assembly of claim 8 , further comprising a sharp, and wherein at least a distal portion of the sharp is configured to receive the distal portion of the glucose sensor.
10 . The glucose sensor insertion assembly of claim 9 , wherein the sensor electronics assembly is configured to be released from the glucose sensor insertion assembly and applied to the subject.
11 . The glucose sensor insertion assembly of claim 10 , wherein the sensor electronics disposed within the housing of the sensor electronics assembly are configured to be electrically coupled with the proximal portion of the glucose sensor prior to application of the sensor electronics assembly to the subject.
12 . The glucose sensor insertion assembly of claim 11 , wherein the printed circuit board comprises an aperture, and wherein the sharp is configured to extend through the aperture.
13 . The glucose sensor insertion assembly of claim 12 , wherein the at least a distal portion of the sharp is configured to pierce the skin surface and position the distal portion of the glucose sensor under the skin surface and in contact with the bodily fluid of the subject.
14 . The glucose sensor insertion assembly of claim 13 , wherein the sharp is configured to be automatically retracted such that the at least a distal portion of the sharp is retracted from the skin surface to a position entirely within the interior of the applicator.
15 . The glucose sensor insertion assembly of claim 14 , further comprising an elastomeric connector comprising a first section, a second section symmetrical to the first section, and a hinge joining the first section and the second section, and wherein the proximal portion of the glucose sensor is configured to be captured between the first section and the second section when the elastomeric connector is in a folded configuration, and wherein the elastomeric connector is configured to establish electrical connectivity between the glucose sensor and the printed circuit board.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 17/531,265, filed Nov. 19, 2021, which is a continuation of U.S. patent application Ser. No. 15/908,616, filed Feb. 28, 2018, now U.S. Pat. No. 11,179,068, which is a continuation of U.S. patent application Ser. No. 15/610,334, filed May 31, 2017, now U.S. Pat. No. 9,931,066, which is a continuation of U.S. patent application Ser. No. 15/193,499, filed Jun. 27, 2016, now U.S. Pat. No. 9,693,713, which is a continuation of U.S. patent application Ser. No. 13/710,460, filed Dec. 11, 2012, now U.S. Pat. No. 9,402,570, which claims priority to U.S. Provisional Application No. 61/569,287, filed Dec. 11, 2011, all of which are incorporated herein by reference in their entireties for all purposes. BACKGROUND Diabetes Mellitus is an incurable chronic disease in which the body does not produce or properly utilize insulin. Insulin is a hormone produced by the pancreas that regulates blood sugar (glucose). In particular, when blood sugar levels rise, e.g., after a meal, insulin lowers the blood sugar levels by facilitating blood glucose to move from the blood into the body cells. Thus, when the pancreas does not produce sufficient insulin (a condition known as Type 1 Diabetes) or does not properly utilize insulin (a condition known as Type II Diabetes), the blood glucose remains in the blood resulting in hyperglycemia or abnormally high blood sugar levels. The vast and uncontrolled fluctuations in blood glucose levels in people suffering from diabetes cause long-term, serious complications. Some of these complications include blindness, kidney failure, and nerve damage. Additionally, it is known that diabetes is a factor in accelerating cardiovascular diseases such as atherosclerosis (hardening of the arteries), leading to stroke, coronary heart disease, and other diseases. Accordingly, one important and universal strategy in managing diabetes is to control blood glucose levels. One element of managing blood glucose levels is the monitoring of blood glucose levels. Conventional in vitro techniques, such as drawing blood samples, applying the blood to a test strip, and determining the blood glucose level using colorimetric, electrochemical, or photometric test meters, may be employed. Another technique for monitoring glucose levels uses an in vivo analyte monitoring system, which measures and stores sensor data representative of glucose levels automatically over time. Unlike conventional in vitro blood glucose monitoring approaches, in vivo analyte monitoring systems use an insertable or implantable in vivo sensor that is positioned to be in contact with interstitial fluid of a user for a period of time to detect and monitor glucose levels. Prior to use of an in vivo sensor, at least a portion of the sensor is positioned under the skin. An applicator assembly can be employed to insert the sensor into the body of the user. For insertion of the sensor, a sharp engaged with the sensor, pierces the skin of the user and is then removed from the body of the user leaving the sensor in place. The in vivo-positioned sensor can be connected to other system components such as sensor electronics contained in a unit that can be held onto the skin. To realize fully the advantages associated with such systems, what is needed are applicator systems configured to handle insertion, as well as packaging and user interface issues, that are easy-to-use, reliable and minimize both user inconvenience and pain. The present invention provides such solutions and additional or alternative advantages as described below and/or as may be appreciated by those of skill in the art upon review of the subject disclosure. SUMMARY The present invention includes packaging, loading systems, applicators, and elements of the on-body devices themselves. According to embodiments of the present invention, an on-body device includes an electronics assembly and a sensor assembly. The sensor assembly includes a sensor and a connector for coupling the sensor to the electronics assembly. In addition, a sharp can be provided that supports the sensor and allows a distal end of the sensor to be placed under a user's skin. In some embodiments, the invention includes the connection of electrochemical analyte sensors to and/or within associated other monitoring components such as system devices that are configured to be held in place on body. The approaches variously involve the use of unique sensor and unique ancillary element arrangements to facilitate assembly of separate on-body devices and sensor assembly units that are kept apart until the user brings them together. Methods associated with such use also form part of the inventive subject matter. Certain embodiments are described that include an analyte sensor (e.g., a glucose sensor) and an applicator assembly to position a portion of the sensor beneath a skin surface, as well as methods of positionin