Medical device insertion

• US 8,545,403 B2
• Filed: 12/28/2006
• Issued: 10/01/2013
• Est. Priority Date: 12/28/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peyser, Thomas A., Taub, Marc B., Stafford, Gary Ashley, Hoss, Udo, Lee, Daniel H., Mazza, John C., Naegeli, Andrew H., Morgan, Roy E.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/617,698
• Publication Number:
  US 20070249922A1
• Time in Patent Office: 2,469 Days
• Field of Search: 600/547, 600/345, 600/583, 600/576, 600/562, 600/347, 600/365, 606181-182, 606/185, 606/183
• US Class Current: 600/365
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes

Abstract

Devices and methods for inserting at least a portion of a medical device in a patient are provided. Embodiments include medical device insertions that employ a plurality of insertion stages. Also provided are systems and kits for use in analyte monitoring.

Claims

1. A method of inserting an analyte sensor, comprising:

positioning a portion of an analyte sensor including a sensing layer removably nested within a sensor introducer at a first predetermined depth below a skin surface of a patient at a first selected velocity; and

positioning the portion of the analyte sensor without the sensor introducer at a second predetermined depth at a second selected velocity,

wherein the second predetermined depth is greater than the first predetermined depth; and

wherein the cross-sectional area of the incision at the first predetermined depth made by the sensor introducer with the nested analyte sensor is greater than the cross-sectional area of the incision made by the analyte sensor without the sensor introducer at the second predetermined depth.

2. The method of claim 1 wherein positioning the portion of the sensor at the first predetermined depth includes piercing the skin surface at a first angle relative to the skin surface.

3. The method of claim 2 wherein the first angle includes one of a 90 degrees relative to the skin surface or less than 90 degrees relative to the skin surface.

4. The method of claim 1 wherein the first velocity and the second velocity are different.

5. The method of claim 4 wherein the second selected velocity is less than the first selected velocity.

6. The method of claim 1 wherein the first predetermined depth is not deeper than the epidermis.

7. The method of claim 1 wherein the first predetermined depth is not greater than about 1.5 mm below the skin surface.

17. The device of claim 7 further comprising means for decreasing velocity comprising one of viscous dashpots, air damping, friction and adding mass.

8. A sensor insertion device, comprising:

a sensor having a portion including a sensing layer; and

a sensor introducer operatively coupled to an insertion mechanism to control the displacement of the sensor introducer and the portion of the sensor, the sensor introducer configured to pierce through a skin layer of a patient to position the first portion of the sensor at a first predetermined depth and at a first predetermined incision width at the first predetermined depth under the skin layer at a first selected velocity, the portion of the sensor configured to reach a second predetermined depth and at a second predetermined incision width at the second predetermined depth under the skin layer at a second selected velocity, wherein the second predetermined depth is greater than the first predetermined depth, and wherein the first predetermined incision width at the first predetermined depth is greater than the second predetermined incision width at the second predetermined depth.

9. The device of claim 8 wherein the first velocity is greater than the second velocity.

10. The device of claim 8 wherein the sensor is configured to reach the first predetermined depth substantially contemporaneously with the sensor introducer reaching the first predetermined depth.

11. The device of claim 8 wherein the sensor includes a glucose sensor.

12. The device of claim 8 wherein the sensor introducer includes a needle portion.

13. The device of claim 12, wherein needle portion includes a hollow segment and wherein at least a portion of the sensor is substantially provided within the hollow segment of the needle portion.

14. The device of claim 8 wherein the sensor introducer is substantially entirely removed from the patient before the sensor reaches the second predetermined depth.

15. The device of claim 8 wherein the sensor is in fluid contact with an analyte of the patient at the second predetermined depth.

16. The device of claim 8 wherein tissue trauma substantially at the second predetermined depth is less than the tissue trauma substantially at the first predetermined depth.

18. A method of analyte sensor insertion, comprising:

piercing a skin layer of a patient to a first predetermined depth at a first selected velocity to position a portion of an analyte sensor including a sensing layer at the first predetermined depth, wherein the incision at the first predetermined depth has a first predetermined incision cross-sectional area; and

displacing the portion of the analyte sensor to a second predetermined depth at a second selected velocity, wherein the incision at the second predetermined depth has a second predetermined incision cross-sectional area,

wherein the second predetermined depth is greater than the first predetermined depth; and

wherein the first predetermined incision cross-sectional area at the first predetermined depth is greater than the second predetermined incision cross-sectional area at the second predetermined depth.

19. The method of claim 18 wherein tissue trauma substantially at the second predetermined depth is less than the tissue trauma substantially at the first predetermined depth.

20. The method of claim 18 wherein the analyte sensor is in fluid contact with an analyte of the patient to be monitored at the second predetermined depth.

21. A method of inserting a sensor within a body, comprising:

contacting a sensor insertion device to a skin surface; and

actuating the sensor insertion device to incise the skin surface with a sensor introducer and to insert a portion of a sensor including a sensing layer through the incised skin surface into subcutaneous adipose tissue;

wherein at least two different selected velocities are used to incise the skin surface and to insert the portion of the sensor into subcutaneous adipose tissue; and

wherein the width of the incision created by incising the skin surface using the sensor introducer is greater than a width of a subsequent incision created within the skin surface incision by driving the portion of the sensor including a sensing layer alone into subcutaneous adipose tissue.

22. The method of claim 21, wherein at least one velocity differs from a second velocity by about 25% to about 90%.

23. The method of claim 21, wherein a velocity to incise the skin surface is in the range from about 4 m/s to about 8 m/s.

24. The method of claim 21, wherein a velocity to insert the sensor through the incised skin surface into subcutaneous adipose tissue is in the range from about 0.025 m/s to about 0.5 m/s.

25. The method of claim 21, wherein the skin surface is incised to a first predetermined depth and the sensor is inserted to a second predetermined depth, wherein the second predetermined depth is greater than the first predetermined depth.