NEEDLE FOR TRANSCUTANEOUS ANALYTE SENSOR DELIVERY

• US 20160338734A1
• 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:
  US15/160,903
• Publication Number:
  US 20160338734A1
• 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 method of delivering a sensor, the method comprising:

advancing a cutting edge on a wall structure of a needle through an outer skin layer to cut an opening in the outer skin layer;

bluntly stretching, with a blunt contour extending at least 50% of a cross dimension of the wall structure viewed along a central axis of the wall structure, the opening in the outer skin layer; and

releasing the sensor at a sensor depth.

2. The method of claim 1, wherein advancing the cutting edge is before bluntly stretching.

3. The method of claim 1, including further advancing the cutting edge until the cutting edge is at the sensor depth.

4. The method of claim 1, wherein releasing the sensor includes retracting the needle back from the sensor depth and over the sensor.

5. The method of claim 1, wherein the method reduces wound volume compared to a straight conventional beveled needle by at least 15%.

6. The method of claim 5, wherein the method reduces wound volume by at least 35%.

7. The method of claim 1, wherein the method reduces an incidence of dip and recover to less than 5% of a patient population.

8. The method of claim 1, wherein the method reduces an incidence of dip and recover to less than 1% of a patient population.

9. The method of claim 1, wherein releasing the sensor includes laterally sliding the sensor through an elongate window defined in the wall structure.