Granted Patent B2

US 12,642,456 · App. 17/842,624 · Granted Jun 2, 2026

Inventors: Joseph J. Baker (Vista, CA); Philip Thomas Pupa (San Diego, CA); Timothy Joseph Goldsmith (San Diego, CA); Jonathan Bodnar (Keller, TX); Jason Halac (San Diego, CA); John Michael Gray (San Diego, CA); Neal Davis Johnston (Dallas, TX); Justen Deering England (San Francisco, CA); Peter C. Simpson (Cardiff by the Sea, CA); Paul V. Neale (San Diego, CA); Jennifer Blackwell (San Diego, CA); Maria Noel Brown Wells (San Diego, CA); Kenneth Pirondini (San Diego, CA); Andrew Michael Reinhardt (Santee, CA); Mark Douglas Kempkey (Vista, CA); Young Woo Lee (San Diego, CA); Warren Terry (Poway, CA); Patrick John Castagna (San Diego, CA); David A. Keller (Encinitas, CA); Randall Scott Koplin (Middleton, WI); Andrew Joncich (Madison, WI); Nirav Bhatt (Irvine, CA)

Assignee: DexCom, Inc.

A61B5/14503A61B5/0004A61B5/14532A61B5/6833A61B5/6849A61B5/742A61B17/3468A61B5/14546A61B5/6848A61B5/688A61B2560/0406A61B2560/063A61B2562/12A61B2562/242

Abstract

Claims (31)

1 . A method of manufacturing a plurality of applicators, wherein each applicator of the plurality of applicators is configured to apply an on-skin assembly to a skin of a host, the method comprising:

providing an insertion assembly for each applicator of the plurality of applicators, wherein each insertion assembly is configured to insert at least a portion of the respective on-skin assembly into the skin of the host;

providing a housing for each applicator of the plurality of applicators, wherein each housing is configured to receive the respective insertion assembly, each housing comprising an aperture through which the respective on-skin assembly is configured to pass;

providing an actuation member for each applicator of the plurality of applicators, wherein each actuation member is configured to, upon activation, actuate the respective insertion assembly to insert at least the portion of the respective on-skin assembly into the skin of the host;

simultaneously exposing at least an internal environment of each housing of the plurality of applicators to an ingress of a sterilizing gas;

simultaneously allowing for an egress of the sterilizing gas from the internal environment of each housing of the plurality of applicators to an external environment;

wherein each housing of the plurality of applicators includes a layer configured to allow for the exposure of the ingress of the sterilizing gas into the internal environment of each housing and for the egress of the sterilizing gas from the internal environment of each housing to the external environment; and

providing a removable cap for each applicator of the plurality of applicators, wherein each removable cap is secured to the respective housing, wherein each removable cap has a distal end and a platform raised from the distal end, wherein each platform has at least one aperture.

2 . The method of claim 1 , further comprising sealing the internal environment of each housing from the external environment of each housing, wherein at least sealing the internal environment of each housing from the external environment of each housing is performed simultaneously for the plurality of applicators.

3 . The method of claim 2 , wherein sealing the internal environment of each housing from the external environment of each housing comprises subjecting the plurality of applicators to a partial vacuum exceeding a threshold such that a sealing element of each of the plurality of applicators transitions from being permeable to the sterilizing gas to being impermeable to the sterilizing gas.

4 . The method of claim 3 , wherein sealing the internal environment of each housing from the external environment of the housing comprises subjecting the plurality of applicators to a physical force sufficient to cause the sealing element of each of the plurality of applicators to transition from a first physical configuration permeable to the sterilizing gas to a second physical configuration impermeable to the sterilizing gas.

5 . The method of claim 3 , wherein sealing the internal environment of each housing from the external environment of the housing comprises subjecting the sealing element, comprising a plurality of perforations, of each the plurality of applicators to a temperature sufficient to at least partially melt each of the sealing elements thereby sealing the plurality of perforations in each of the sealing elements.

6 . The method of claim 3 , wherein sealing the internal environment of each housing from the external environment of the housing comprises subjecting the sealing element, comprising a porous polymeric component, of each of the plurality of applicators to a temperature sufficient to form a sintered layer in the porous polymeric component of each sealing element.

7 . The method of claim 3 , wherein sealing the internal environment of each housing from the external environment of the housing comprises depositing a layer impermeable to the sterilizing gas on at least a portion of each of the plurality of applicators.

8 . The method of claim 7 , wherein the sealing element comprises at least one of a metallic foil, a metallic substrate, an aluminum oxide coated polymer, parylene, a polymer coated with a metal applied via vapor metallization, a silicon dioxide coated polymer, or any material having a moisture vapor transmission rate less than 10 grams/100 in2 or preferably less than 1 grams/100 in2.

9 . The method of claim 1 , wherein each platform includes a plurality of channels.

10 . A method of manufacturing a plurality of applicators, wherein each applicator of the plurality of applicators is configured to apply an on-skin assembly to a skin of a host, the method comprising:

providing an insertion assembly for each applicator of the plurality of applicators, wherein each insertion assembly is configured to insert a sensor of the respective on-skin assembly into the skin of the host, wherein each respective on-skin assembly includes the respective sensor connected to a sensor electronics;

providing a housing for each applicator of the plurality of applicators, wherein each housing is configured to receive the respective insertion assembly, each housing comprising an aperture through which the respective on-skin assembly is configured to pass;

providing an actuation member for each applicator of the plurality of applicators, wherein each actuation member is configured to, upon activation, actuate the respective insertion assembly to insert the respective sensor of the respective on-skin assembly into the skin of the host;

providing a removable cap for each applicator of the plurality of applicators, wherein each removable cap is secured to the respective housing, wherein each removable cap has a distal end and a platform raised from the distal end, wherein each platform has at least one aperture; and

providing a layer for each applicator of the plurality of applicators, wherein each layer is coupled to the distal end of the respective removable cap, wherein each layer is configured to seal an internal environment of the respective housing from an external environment of the respective housing.

11 . The method of claim 10 , wherein each actuation member comprises a material that is permeable to a sterilizing gas.

12 . The method of claim 10 , further comprising providing a sealing element for each applicator of the plurality of applicators, wherein each sealing element is configured to provide a sterile barrier and a vapor barrier between an internal environment of each housing and the external environment of each housing, wherein each housing comprises a vent configured to be permeable to a sterilizing gas.

13 . The method of claim 12 , wherein each sealing element is configured to seal the respective vent.

14 . The method of claim 12 , wherein each sealing element comprises a peelable layer coupled to at least a portion of the respective housing.

15 . The method of claim 14 , wherein each peelable layer is configured to provide a tamper indication when removed.

16 . The method of claim 14 , wherein each peelable layer is configured to seal a distal opening of the respective housing.

17 . The method of claim 16 , wherein each peelable layer is configured to further seal the respective actuation member.

18 . The method of claim 14 , wherein each peelable layer is configured to seal a vent configured to be permeable to a sterilizing gas.

19 . The method of claim 10 , wherein each platform includes a plurality of channels.

Assignments (1)

Continuity (4)

References Cited (208)