Needle for transcutaneous analyte sensor delivery

Patent metadata

Field	Value
Publication number	US-11259842-B2
Application number	US-201615160516-A
Country	US
Kind code	B2
Filing date	May 20, 2016
Priority date	May 22, 2015
Publication date	Mar 1, 2022
Grant date	Mar 1, 2022

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 needle for delivering a sensor through an outer skin layer and into a sensor depth, the needle comprising:
a wall structure having a central axis, an outer surface, an interior surface, a tip, and at least one cross dimension and defining at least one inner dimension sized to contain the sensor for delivery, wherein the at least one inner dimension is configured to receive a bent portion of the sensor, wherein the interior surface of the wall structure comprises a lubricant coating, wherein the wall structure defines a first beveled edge and a second beveled edge;
at least one cutting edge on the wall structure configured to pierce the outer skin layer, wherein the at least one cutting edge is formed only on the second beveled edge and not the first beveled edge, and wherein the at least one cutting edge formed on the second beveled edge is less than 50% of a combined beveled edge of the first beveled edge and the second beveled edge; and
a bend of the wall structure forming at least one blunt contour on the wall structure, the bend extending through the central axis and positioning the tip between the central axis and an axis of the interior surface of the wall structure, the blunt contour configured to bluntly dissect tissue as the wall structure advances into the sensor depth;
wherein the blunt contour, viewed along the central axis of the wall structure, occupies more than 50% of the cross dimension of the wall structure;
wherein a ratio of a blunt surface area of the wall structure to a cutting surface area of the wall structure viewed along the central axis is no greater than 2.74; and
wherein the wall structure is configured for removal from the outer skin layer to leave the sensor at the sensor depth.

2. The needle of claim 1 , wherein the blunt contour is more than 60% of the cross dimension of the wall structure.

3. The needle of claim 1 , wherein the at least one 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.

4. The needle of claim 1 , wherein the blunt contour is at least ⅔ of an area centered on the central axis and circumscribing an outer edge of the blunt contour.

5. The needle of claim 4 , wherein the area is a circular area and has a diameter matching a diameter of the wall structure.

6. The needle of claim 1 , wherein the at least one cutting edge is formed on less than 40% of the combined beveled edge.

7. The needle of claim 1 , wherein the blunt contour is sufficiently large in proportion to the cutting edge to reduce wound volume by at least 15%.

8. The needle of claim 1 , wherein at least one of the first beveled edge or the second beveled edge is angled at least 7 degrees.

9. The needle of claim 8 , wherein at least one of the first beveled edge or the second beveled edge is angled at least 10 degrees.

10. The needle of claim 1 , wherein the includes a bend is positioned proximal to the cutting edge.

11. The needle of claim 10 , wherein the bend is subjacent to at least one of the at least one cutting edge, the first beveled edge, or the second beveled edge.

12. The needle of claim 11 , wherein the bend is at least 13 degrees.

13. The needle of claim 1 , wherein the wall structure defines a longitudinal slit connected in communication with the inner dimension.

14. The needle of claim 13 , wherein the wall structure defines an elongate opening and the inner dimension is a diameter of the opening and wherein the longitudinal slit is in communication with the elongate opening.

15. The needle of claim 14 , wherein the elongate opening and the longitudinal slit extend entirely through a distal edge of the wall structure to form a cross sectional C-shape.

16. The needle of claim 1 , wherein the first beveled edge is proximal to the second beveled edge, wherein the first beveled edge has an angle less than the second beveled edge.

17. The needle of claim 1 , wherein only a portion of the first beveled edge and the second beveled edge positioned within a circle centered on the central axis and circumscribed about a bottom edge of the wall structure is sharpened, and a portion of the first beveled edge and the second beveled edge positioned outside of the circle is rounded.

18. The needle of claim 17 , wherein the circle has a same diameter as a diameter of the wall structure.

19. The needle of claim 1 , wherein the bend extends towards an opposite side of the wall structure along the cross dimension of the wall structure and positions the tip no more than 65% across the cross dimension of the wall structure.

20. The needle of claim 1 , wherein the bend has an angle of between 10 degrees and 20 degrees.

Assignees

• Dexcom Inc

Inventors

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

Classifications

• A61B17/3468 Primary

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

• A61M5/3286

  Needle tip design, e.g. for improved penetration · CPC title

• A61B2017/3456

  blunt · CPC title

• A61B5/14865

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

• A61B5/14532 Primary

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