Needle for transcutaneous analyte sensor delivery

Patent metadata

Field	Value
Publication number	US-2016338734-A1
Application number	US-201615160903-A
Country	US
Kind code	A1
Filing date	May 20, 2016
Priority date	May 22, 2015
Publication date	Nov 24, 2016
Grant date	—

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.

First claim

What is claimed is:

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.

Assignees

• Dexcom Inc

Inventors

• Shah Neel
• Blackwell Jennifer
• Hughes Jonathan
• Lee Ted Tang
• Simpson Peter C
• Wang Shanger

Classifications

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B17/3468 Primary

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61B5/14503

  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 title

• A61B2560/063

  Devices specially adapted for delivering implantable medical measuring apparatus · CPC title

• A61B5/14865

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title