Method and apparatus for insertion of a sensor

• US 9,615,851 B2
• Filed: 03/08/2012
• Issued: 04/11/2017
• 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: Neinast, Mark, Bruce, Robert, Ward, W. Kenneth, Sass, Richard G., Fortuna, Jon
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/415,828
• Publication Number:
  US 20120265042A1
• Time in Patent Office: 1,860 Days
• Field of Search: 600345-366, 600309
• 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 adapted to provide axial support to a flexible analyte sensor wherein the stiffness of the flexible analyte sensor is about 1.4 to about 22.6 grams-force per millimeter of deflection for an unsupported length of 10 millimeters; and

an injection activation device associated with the guidance structure, said 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; and

wherein the high speed motive force is 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, 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, and wherein the buckling length of the flexible analyte sensor is determined by a formula Pcr=π

²*k/(3*L²), wherein Pcr is a value of the high speed motive force applied to the sensor, k is a stiffness of the flexible analyte sensor, and L is the unsupported length of the flexible analyte sensor.

2. The insertion device of claim 1, wherein the velocity of the flexible analyte sensor at the time of insertion is approximately 6.4 meters per second.

3. The insertion device of claim 1, further comprising a housing having a bottom surface associated with the guidance structure, the guidance structure configured so that the flexible analyte sensor passes through the exit port at an angle from 10 to 40 degrees with respect to the bottom surface of the housing.

4. The insertion device of claim 3, further comprising a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site such that the flexible analyte sensor is inserted into the skin at an angle that is substantially perpendicular to a plane of a local skin surface at the insertion site.

5. The insertion device of claim 3, wherein the flexible analyte sensor is inserted with an inserted length of the sensor of at least 12 millimeters.

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

7. The insertion device of claim 1, wherein the high speed motive force has a value of about 22 Newtons.

8. The insertion device of claim 1, wherein an insertion angle of the sensor with respect to a plane of the skin is from 10 to 40 degrees.

9. An insertion device comprising:

a guidance structure adapted to provide axial support to a flexible analyte sensor, the guidance structure having an exit port;

an injection activation device associated with the guidance structure, said 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; 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 the exit port is less than the buckling length of the sensor, and wherein the high speed motive force is 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 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.

10. The insertion device of claim 9, wherein the tensioning structure includes a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site.

11. The insertion device of claim 9, wherein the tensioning structure includes an adhesive patch disposed on the surface of the skin, the adhesive patch including a hole surrounding an insertion site of the sensor.

12. The insertion device of claim 9, wherein the high speed motive force has a value of about 11 to 53 Newtons.

13. The insertion device of claim 9, wherein the high speed motive force has a value of about 22 Newtons.

14. The insertion device of claim 9, wherein an insertion angle of the sensor with respect to a plane of the skin is from 10 to 40 degrees.

15. The insertion device of claim 9, wherein the velocity of the flexible analyte sensor at the time of insertion is approximately 6.4 meters per second.

16. The insertion device of claim 9, further comprising a housing having a bottom surface associated with the guidance structure, the guidance structure configured so that the flexible analyte sensor passes through the exit port at an angle from 10 to 40 degrees with respect to the bottom surface of the housing.

17. The insertion device of claim 16, further comprising a nub surrounding the exit port of the guidance structure, the nub configured to indent the skin at an insertion site such that the flexible analyte sensor is inserted into the skin at an angle that is substantially perpendicular to a plane of a local skin surface at the insertion site.

18. The insertion device of claim 16, wherein the flexible analyte sensor is inserted with an inserted length of the sensor of at least 12 millimeters.