Method and apparatus for insertion of a sensor
A device and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin. Such a device allows a sensor to penetrate mammalian skin without the use of an introducer device such as a needle. A device in accordance with embodiments of the present disclosure includes a housing for attachment to mammalian skin including an exit port for receiving the distal end of a biosensor and an injection activation device including a mechanism for forcing the sensing device from a first position within the housing, through the exit port to a second position, with sufficiently high velocity to partially penetrate the mammalian skin.
1. An insertion device, comprising:
a guidance structure that provides a passageway for a flexible analyte sensor held within the guidance structure;
at least one guide member fully contained within the guidance structure, the at least one guide member adapted to axially support the flexible analyte sensor within the guidance structure as the at least one guide member and flexible analyte sensor pass within the guidance structure;
an injection activation device that applies a high-speed motive force solely to the flexible analyte sensor such that only the flexible analyte sensor is inserted into skin of a user, wherein:
a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second, and
the at least one guide member remains fully within the guidance structure throughout an entirety of insertion of the flexible analyte sensor into the skin; and
a tensioning structure configured to tension a surface of the skin so that a distance from the surface of the skin at an insertion site on the surface of the skin to an exit port of the guidance structure is less than a buckling length of the flexible analyte sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than the buckling length of the flexible analyte sensor.
2. The insertion device of claim 1 , wherein the at least one guide member comprises a sabot, a spiral of plastic, a rectangular metallic guide, an open cell foam plastic cylinder, or a thin plastic disk.
3. The insertion device of claim 1 , further comprising a housing having the injection activation device, the injection activation device being at least partially fixed within the housing; and an opening of the housing aligned with the guidance structure such that the flexible analyte sensor initially contained entirely within the housing is able to pass through both the opening of the housing and the guidance structure upon application of the high-speed motive force.
4. The insertion device of claim 3 , wherein the opening of the housing is flush against the exit port of the guidance structure.
5. The insertion device of claim 1 , wherein the guidance structure is a tube with a circular diameter.
6. The insertion device of claim 1 , further comprising an analyte sensor associated with the guidance structure.
7. The insertion device of claim 1 , wherein the guidance structure is curved.
8. The insertion device of claim 7 , wherein the guidance structure is a curved hollow tube with a circular cross-section.
9. The insertion device of claim 7 , wherein the guidance structure includes: a top surface that lies at least partially outside a radius of an arc formed by the flexible analyte sensor during insertion; and a partially open region that lies at least partially inside the radius of the arc formed by the flexible analyte sensor during insertion.
10. The insertion device of claim 1 , wherein the injection activation device that applies the high-speed motive force solely to the flexible analyte sensor includes a device selected from the group consisting of: a solenoid; a spring; a CO2 cartridge; an air pump; and a structure adapted to maintain a sensor in a bowed configuration such that the sensor holds potential energy.
11. The insertion device of claim 1 , wherein the high-speed motive force is about 11 Newtons to about 53 Newtons.
12. The insertion device of claim 1 , wherein the tensioning structure includes a nub configured to indent the skin at the insertion site.
13. A method for auto-insertion of a flexible analyte sensor into animal skin comprising:
placing an auto-insertion device on the skin, the auto-insertion device comprising:
a guidance structure that provides a passageway for the flexible analyte sensor held within the guidance structure;
at least one guide member fully within the guidance structure, the at least one guide member adapted to axially support the flexible analyte sensor within the guidance structure as the at least one guide member and flexible analyte sensor pass within the guidance structure;
an injection activation device that applies a high-speed motive force solely to the flexible analyte sensor such that only the flexible analyte sensor is inserted into the skin, wherein:
a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second, and
the at least one guide member remains fully within the guidance structure throughout an entirety of insertion of the flexible analyte sensor into the skin; and
a tensioning structure configured to tension a surface of the skin so that a distance from the surface of the skin at an insertion site on the surface of the skin to an exit port of the guidance structure is less than a buckling length of the flexible analyte sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than the buckling length of the flexible analyte sensor; and
activating the injection activation device to cause only the flexible analyte sensor to be inserted into the skin.
14. The method of claim 13 , wherein the high-speed motive force is about 11 Newtons to about 53 Newtons.
15. The method of claim 13 , wherein the tensioning structure includes a nub configured to indent the skin at the insertion site.
16. An insertion device, comprising:
a guidance structure that provides axial support to a flexible analyte sensor held within the guidance structure;
an injection activation device that applies a high-speed motive force solely to the flexible analyte sensor such that a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second; and
a tensioning structure configured to tension a surface of skin so that a distance from the surface of the skin at an insertion site on the surface of the skin to an exit port of the guidance structure is less than a buckling length of the flexible analyte sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than the buckling length of the flexible analyte sensor.
17. The insertion device of claim 16 , wherein the tensioning structure includes a nub configured to indent the skin at the insertion site.
18. A method for auto-insertion of a flexible analyte sensor into animal skin comprising:
placing an auto-insertion device on the skin, the auto-insertion device comprising:
a guidance structure that provides axial support to the flexible analyte sensor held within the guidance structure;
an injection activation device that applies a high-speed motive force solely to the flexible analyte sensor such that a velocity of the flexible analyte sensor at a time of insertion is approximately 5 meters per second to approximately 15 meters per second; and
a tensioning structure configured to tension a surface of the skin so that a distance from the surface of the skin at an insertion site on the surface of the skin to an exit port of the guidance structure is less than a buckling length of the flexible analyte sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than the buckling length of the flexible analyte sensor; and activating the injection activation device to cause only the flexible analyte sensor to be inserted into the skin.
19. The method of claim 18 , wherein the tensioning structure includes a nub configured to indent the skin at the insertion site.