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US-12616396-B2 - Analyte sensor devices, connections, and methods

US12616396B2US 12616396 B2US12616396 B2US 12616396B2US-12616396-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
20211119

Claims (20)

  1. 1 . An assembly comprising: an on-body device comprising: (1) a glucose sensor assembly comprising: a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor; and a distal section comprising a distal portion of the glucose sensor configured to be positioned under a skin surface and in contact with a bodily fluid of a subject; (2) a housing comprising: a top portion comprising a top exterior surface and an aperture; a base portion configured to be adhered to the skin surface of the subject by an adhesive patch; and a first space defined by the top portion and the base portion; and (3) sensor electronics positioned within the first space, the sensor electronics comprising a processor, a battery, and a printed circuit board, wherein the base portion of the housing comprises a recess in a bottom exterior surface, the recess comprising a distal-facing opening, wherein the recess defines a second space different from the first space, and wherein the recess is configured to receive the connector support via the distal-facing opening, and wherein the connector support of the glucose sensor assembly is disposed in the recess of the base portion such that the glucose sensor is electrically coupled with the sensor electronics by the connector support.
  2. 2 . The assembly of claim 1 , wherein the housing further comprises a side wall, and wherein the sidewall is located between the top exterior surface of the top portion of the housing and the bottom exterior surface of the base portion of the housing.
  3. 3 . The assembly of claim 2 , wherein the sensor electronics further comprise a wireless communications facility.
  4. 4 . The assembly of claim 3 , wherein the housing further comprises a plurality of engagement recesses circumferentially disposed thereon.
  5. 5 . The assembly of claim 4 , further comprising an applicator comprising a sharp.
  6. 6 . The assembly of claim 5 , wherein the connector support of the glucose sensor assembly is disposed in the recess of the base portion such that the glucose sensor is electrically coupled with the sensor electronics by the connector support when the on-body device and the sharp are in a first position entirely within the applicator, wherein the applicator is configured to advance the on-body device and the sharp from the first position to a second position such that a distal end of the sharp pierces the skin surface of the subject and the base portion of the housing is adhered to the skin surface of the subject, and wherein the applicator is further configured to retract the sharp from the second position to a retracted position entirely within the applicator.
  7. 7 . The assembly of claim 6 , wherein the recess of the base portion is configured to receive the connector support via the distal-facing opening while the sensor electronics are in the first space.
  8. 8 . The assembly of claim 7 , wherein the sharp extends through the aperture of the top portion of the housing when the on-body device and the sharp are in the first position.
  9. 9 . The assembly of claim 7 , wherein the aperture of the top portion of the housing is a first aperture, wherein the printed circuit board comprises a second aperture, and wherein the sharp extends through the second aperture when the on-body device and the sharp are in the first position.
  10. 10 . The assembly of claim 9 , wherein the plurality of engagement recesses is detachably engaged to the applicator when the on-body device and the sharp are in the first position.
  11. 11 . The assembly of claim 7 , wherein the connector support is electrically coupled with the sensor electronics via an interface that is external to the first space, and wherein the interface is disposed within the recess of the base portion.
  12. 12 . The assembly of claim 7 , wherein the glucose sensor assembly further comprises a bent section between the proximal section and the distal section, wherein the proximal section and the distal section are approximately perpendicular to each other when the on-body device and the sharp are in the first position.
  13. 13 . The assembly of claim 7 , wherein each engagement recess of the plurality of engagement recesses is disposed on the side wall of the housing, and wherein each engagement recess of the plurality of engagement recesses comprises a concave portion.
  14. 14 . The assembly of claim 7 , wherein the distal-facing opening comprises a polygonal cross-sectional area, and wherein a shape of the connector support of the glucose sensor assembly corresponds with the polygonal cross-sectional area of the distal-facing opening.
  15. 15 . The assembly of claim 7 , wherein the side wall of the housing comprises a first portion and a second portion, wherein the first portion of the side wall is substantially orthogonal to the bottom exterior surface of the base portion of the housing, and wherein the second portion of the side wall is non-orthogonal to the top exterior surface of the top portion of the housing.
  16. 16 . The assembly of claim 7 , wherein on-body device is configured to communicate data indicative of a glucose level to a receiver unit.
  17. 17 . The assembly of claim 7 , wherein the plurality of engagement recesses is detachably engaged to the applicator when the on-body device and the sharp are in the first position.
  18. 18 . The assembly of claim 7 , wherein the connector support comprises a planar surface.
  19. 19 . The assembly of claim 7 , wherein the on-body device further comprises an elastomeric sealing member disposed within the recess of the base portion.
  20. 20 . The assembly of claim 19 , wherein the elastomeric sealing member is in contact with the connector support.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 15/908,616, filed Feb. 28, 2018, 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 positioning at least a portion of the sensor and methods of analyte testing or monitoring. Further methods include the manner of prep