NEEDLE FOR TRANSCUTANEOUS ANALYTE SENSOR DELIVERY

• US 20160338628A1
• Filed: 05/20/2016
• Published: 11/24/2016
• Est. Priority Date: 05/22/2015
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Shah, Neel, Blackwell, Jennifer, Hughes, Jonathan, Lee, Ted Tang, Simpson, Peter C., Wang, Shanger
• Application Number:
  US15/160,854
• Publication Number:
  US 20160338628A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/3456 blunt
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration

Abstract

The present disclosure relates to a needle including a wall structure, a cutting edge and a blunt contour. The needle advantageously can be used to deliver a sensor (such as a glucose or other analyte sensor) through an outer skin layer and into a sensor depth in a less invasive way than prior art needles. The size of the cutting edge is balanced against a portion of the distal wall structure that has blunt contours. Thus, the needle is capable of cutting the more durable outer skin layer (first phase) and then progressively stretching open the cut for further advancement into the subcutaneous layer (second phase). When the needle is sufficiently advanced, it is retracted leaving the sensor in a desired position. Early testing has shown a reduction of “dip and recover” from glucose sensors delivered using the needle.

Claims

1. A needle for implanting a continuous analyte sensor, comprising:

a wall structure comprising a proximal end and a distal end, wherein the wall structure comprises a lumen with a cross dimension sized to hold a continuous analyte sensor, wherein the distal end comprises a distal tip, wherein the distal tip comprises at least one first bevel and at least one second bevel.

2. The needle of claim 1, wherein the at least one first bevel is proximal to the at least one second bevel, wherein the at least one first bevel has an angle less than the at least one second bevel.

3. The needle of claim 1, wherein the distal tip is positioned from about 5% to about 65% across the cross dimension.

4. A needle for implanting a continuous analyte sensor, comprising:

a wall structure having a central axis, at least one cross dimension and defining at least one inner dimension sized to contain the sensor for delivery;

at least one cutting edge on the wall structure configured to pierce the outer skin layer; and

at least one blunt contour on the wall structure, the blunt contour configured to bluntly dissect tissue as the wall structure advances into the sensor depth, wherein the blunt contour comprises an area viewed along the central axis within a range of 0.85 times to 2.74 times a an area viewed along the central axis and defined by the cutting edge.

5. The needle of claim 4, wherein the wall structure comprises a slot that extends along a length of the wall structure, wherein the slot is dimensioned and shaped to allow the continuous analyte sensor to pass therethrough.

6. The needle of claim 4, wherein the slot has a staggered portion.

7. The needle of claim 4, wherein a portion of the wall structure has a C-shaped cross-section.

8. The needle of claim 4, wherein a portion of the wall structure has a U-shaped cross-section.

9. The needle of claim 4, wherein the needle is configured to withstand without substantial buckling an axial load from about 7.3 times to about 14.6 times of a force directed on the needle to cause insertion.

10. A needle for implanting a continuous analyte sensor, comprising:

a wall structure having a central axis, at least one cross dimension and defining at least one inner dimension sized to contain the sensor for delivery;

at least one cutting edge on the wall structure configured to pierce the outer skin layer; and

at least one blunt contour on the wall structure, the blunt contour configured to bluntly dissect tissue as the wall structure advances into the sensor depth,

wherein the wall structure defines a proximal slot configured to receive a kink of the sensor therein.

11. The needle of claim 10, wherein the blunt contour is more than 60% of the cross dimension of the wall structure.

12. The needle of claim 10, wherein the cutting edge is formed on less than 50% of the beveled edge.

13. The needle of claim 10, wherein the cutting edge, when viewed along the central axis of the wall structure, is spaced closer to the central axis than an adjacent outer edge of the blunt contour.

14. The needle of claim 10, wherein the central axis passes through the blunt contour.

15. The needle of claim 10, wherein the blunt contour includes a bend angle of at least 13 degrees.