Applicators for applying transcutaneous analyte sensors and associated methods of manufacture
Applicators for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. An applicator includes an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host, a housing configured to house the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass, an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host, and a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.
1. A method of manufacturing an applicator configured to apply an on-skin assembly to skin of a host, the method comprising:
providing an insertion assembly including a needle configured to insert at least a portion of the on-skin assembly into the skin of the host;
providing a housing configured to receive the insertion assembly, the housing comprising an aperture through which the on-skin assembly is configured to pass;
exposing at least an internal environment of the housing to a sterilizing gas;
allowing for egress of the sterilizing gas from the internal environment of the housing; and
sealing the internal environment of the housing from an external environment of the housing, wherein the sealing comprises subjecting the applicator to a partial vacuum exceeding a threshold such that a sealing element of the applicator transitions from being permeable to the sterilizing gas to being impermeable to the sterilizing gas.
2. The method of claim 1 , wherein at least sealing the internal environment of the housing from an external environment of the housing is performed simultaneously for a plurality of applicators.
3. The method of claim 2 , wherein sealing the internal environment of the housing from an external environment of the housing comprises subjecting the plurality of applicators to a physical force sufficient to cause a 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.
4. The method of claim 2 , wherein sealing the internal environment of the housing from an external environment of the housing comprises subjecting a 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.
5. The method of claim 2 , wherein sealing the internal environment of the housing from an external environment of the housing comprises subjecting a 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.
6. The method of claim 2 , wherein sealing the internal environment of the housing from an 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.
7. The method of claim 6 , 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/100in2 or preferably less than 1 grams/100in2.
8. A method of manufacturing an applicator configured to apply an on-skin assembly to skin of a host, the method comprising:
providing an insertion assembly including a needle configured to insert at least a portion of the on-skin assembly into the skin of the host;
providing a housing configured to receive the insertion assembly, the housing comprising an aperture through which the on-skin assembly is configured to pass;
providing a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing; and
sealing the internal environment of the housing from the external environment of the housing, wherein the sealing comprises subjecting the applicator to a partial vacuum exceeding a threshold such that the sealing element of the applicator transitions from being permeable to a sterilizing gas to being impermeable to the sterilizing gas.
9. The method of claim 8 , wherein the housing comprises a vent configured to be permeable to the sterilizing gas.
10. The method of claim 9 , wherein the sealing element is configured to seal the vent.
11. The method of claim 8 , wherein the sealing element comprises a peelable layer coupled to at least a portion of the housing.
12. The method of claim 11 , wherein the peelable layer is configured to provide a tamper indication when removed.
13. The method of claim 11 , wherein the peelable layer is configured to seal a distal opening of the housing.
14. The method of claim 11 , wherein the peelable layer is configured to seal a vent configured to be permeable to the sterilizing gas.