METHOD AND APPARATUS FOR INSERTION OF A SENSOR

• US 20170209098A1
• Filed: 02/28/2017
• Published: 07/27/2017
• Est. Priority Date: 11/11/2005
• Status: Active Grant

• Current Assignee: Konamite Limited
• Original Assignee: WaveForm Technologies, Inc. (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Bruce, Robert, Neinast, Mark, Ward, W. Kenneth, Sass, Richard G., Fortuna, Jon
• Granted Patent: US 10,433,789 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

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.

Claims

1. An insertion device, comprising:

a guidance structure having an exit port and providing axial support to a flexible analyte sensor, the guidance structure adapted to allow passage of the flexible analyte sensor upon application of a motive force to the analyte sensor; and

an injection activation device associated with the guidance structure, the injection activation device having a mechanism adapted to apply a high speed motive force to the flexible analyte sensor such that, when the high speed motive force is applied, the flexible analyte sensor moves at least partially through the guidance structure and at least partially passes through the exit port to cause insertion of only the flexible analyte sensor into skin.

2. The insertion device of claim 1, wherein the guidance structure further comprises at least one guide member associated with the guidance structure, the at least one guide member adapted to axially support the analyte sensor within the guidance structure as the analyte sensor passes through the guidance structure.

3. The insertion device of claim 2, 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.

4. 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 a 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.

5. The insertion device of claim 4, wherein the opening of the housing is flush against the exit port of the guidance structure.

6. The insertion device of claim 4, wherein an insertion angle of the sensor with respect to a plane of the skin is from 10 to 40 degrees. [this is highly variable and hard to prove. I'"'"'m thinking we shift to:

wherein the guidance structure is oriented to cause insertion of the analyte sensor at an angle from 10 to 40 degrees with respect to a lower surface of the housing.]

7. The insertion device of claim 1, wherein the guidance structure is a tube with a circular diameter.

8. The insertion device of claim 1, further comprising an analyte sensor associated with the guidance structure and positioned such that the sensor passes through the guidance structure upon application of high speed motive force to the sensor, the high speed motive force applied by the injection activation device.

9. The insertion device of claim 8, wherein the insertion device further comprises at least one guide member associated with both the guidance structure and the analyte sensor, the at least one guide member adapted to fit inside the guidance structure, the at least one guide member adapted to allow the sensor to pass through the at least one guide member.

10. The insertion device of claim 9, 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.

11. The insertion device of claim 1, wherein the guidance structure is a curved guidance structure.

12. The insertion device of claim 11, wherein the curved guidance structure is a curved hollow tube with a circular cross-section.

13. The insertion device of claim 11, wherein the curved guidance structure includes:

a top surface that lies at least partially outside the radius of the arc formed by the sensor during insertion; and

a partially open region that lies at least partially inside the radius of the arc formed by the sensor during insertion.

14. The insertion device of claim 1, wherein the mechanism adapted to apply a high speed motive force 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.

15. The insertion device of claim 1, wherein the high speed motive force has a value of about 11 to 53 Newtons.

16. The insertion device of claim 1, wherein the high speed motive force is configured 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.

17. The insertion device of claim 1, further comprising 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 the exit port is less than the buckling length of the sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than a buckling length of the flexible analyte sensor above which the flexible analyte sensor will buckle from application of the high speed motive force.

18. The insertion device of claim 17, wherein the tensioning structure includes a nub adjacent to the exit port of the guidance structure, the nub configured to indent the skin at an insertion site.

19. A method for autoinsertion of a flexible analyte sensor into animal skin comprising:

placing a guidance structure on skin, the guidance structure having an exit port and providing axial support to a flexible analyte sensor, the guidance structure adapted to allow passage of the flexible analyte sensor upon application of a motive force to the analyte sensor; and

activating an injection activation device associated with the guidance structure, the injection activation device having a mechanism adapted to apply a high speed motive force to the flexible analyte sensor such that, when the high speed motive force is applied, the flexible analyte sensor moves at least partially through the guidance structure and at least partially passes through the exit port to cause insertion of only the flexible analyte sensor into skin.

20. The method of claim 19, wherein the high speed motive force has a value of about 11 to 53 Newtons.

21. The method of claim 19, wherein the high speed motive force is configured 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.

22. The method of claim 19, further comprising 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 the exit port is less than the buckling length of the sensor, and wherein the guidance structure is configured so that an unsupported length of the flexible analyte sensor is less than a buckling length of the flexible analyte sensor above which the flexible analyte sensor will buckle from application of the high speed motive force.

23. The method of claim 22, wherein the tensioning structure includes a nub adjacent to the exit port of the guidance structure, the nub configured to indent the skin at an insertion site.