IP Library Granted Patent US 12,491,310
Granted Patent B2
US 12,491,310 · App. 17/569,965 · Granted Dec 9, 2025

Wearable drug delivery device with removal element

Inventors: David Nazzaro (Groveland, MA); Ian Mclaughlin (Groton, MA); Steven Cardinali (Tewksbury, MA); Alexander Doudoumopoulos (Boxborough, MA)
Assignee: INSULET CORPORATION
A61M5/14248
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Quick Facts
Patent No.
US 12,491,310
App. No.
17/569,965
Granted
Dec 9, 2025
Kind
B2
Abstract

An improved wearable drug delivery device and method for removal are provided. In some embodiments, a device may include a device body coupled to an adhesive layer, and a removal element coupled to the adhesive layer. The removal element may include an end section proximate a perimeter of the adhesive layer and a central section connected to the end section, wherein a force applied to the end section causes the central section to transition from a first configuration to a second configuration.

Claims (20)

1 . A wearable drug delivery device, comprising:

a device body coupled to an adhesive layer; and

a removal element consisting of a loop of cord, string, rope, or wire, having a surface area smaller than the adhesive layer and disposed or embedded in the adhesive layer and configured to be, when the wearable drug delivery device is affixed to a user's skin, between at least a part of the adhesive layer and the user's skin, wherein the removal element comprises:

an end section proximate a perimeter of the adhesive layer; and

a central section connected to the end section, wherein the central section follows a path through the adhesive layer so that a material of the removal element has an overall shape comprising first and second paths parallel to a lengthwise axis of the central section and a plurality of peaks extending from the first and second paths, respectively, away from the lengthwise axis and towards the perimeter of the adhesive layer but not contacting the perimeter of the adhesive layer when the central section is in a first configuration, the removal element in the first configuration having a different shape from the adhesive layer, and a force applied to the end section causes the central section to transition between the first configuration and a second configuration, the transition causing the removal element to move along a surface of the adhesive layer to shear a connection between the adhesive layer and the user's skin.

2 . The wearable drug delivery device of claim 1 , wherein the central section is positioned proximate the perimeter of the adhesive layer in the first configuration, and wherein the central section moves towards a lengthwise axis of the adhesive layer in the second configuration.

3 . The wearable drug delivery device of claim 1 , further comprising a pad between the device body and the adhesive layer.

4 . The wearable drug delivery device of claim 3 , wherein the removal element is positioned either between the pad and the adhesive layer, or along an exterior surface of the adhesive layer.

5 . The wearable drug delivery device of claim 1 , wherein the adhesive layer includes a first end opposite a second end and a first side opposite a second side, and wherein the removal element extends beyond the perimeter of the adhesive layer along the first end or the second end.

6 . A removal system for a wearable drug delivery device, comprising:

a removal element that is disposed on or embedded in an adhesive layer and configured to be, when the wearable drug delivery device is affixed to a user's skin, between at least a part of the adhesive layer and the user's skin, the removal element comprising a continuous loop of cord, string, rope, or wire, having a surface area smaller than the adhesive layer forming:

an end section proximate a perimeter of the adhesive layer; and

a central section connected to the end section, the central section following a path through the adhesive layer so that a material of the removal element has an overall shape comprising first and second paths parallel to a lengthwise axis of the central section and at least one peak extending from the first and second paths, respectively, away from the lengthwise axis and towards the perimeter of the adhesive layer without contacting the perimeter of the adhesive layer, wherein a force applied to the end section causes the central section to transition between a first configuration having a different shape than the adhesive layer and a second configuration to move the removal element along a surface of the adhesive layer to shear a connection between the adhesive layer and the user's skin.

7 . The removal system of claim 6 , wherein the central section is positioned proximate the perimeter of the adhesive layer in the first configuration, wherein the central section moves towards a lengthwise axis of the adhesive layer in the second configuration, and wherein the central section comprises a plurality of peaks extending towards the perimeter of the adhesive layer when the central section is in the first configuration.

8 . The removal system of claim 6 , further comprising a pad between a device body and the adhesive layer.

9 . The removal system of claim 8 , wherein the removal element is positioned between the pad and the adhesive layer.

10 . The removal system of claim 6 , wherein the adhesive layer includes a first end opposite a second end and a first side opposite a second side, and wherein the removal element extends beyond the perimeter of the adhesive layer along the first end or the second end.

11 . The wearable drug delivery device of claim 1 , wherein the removal element has a diameter of 0.001 to 0.002 inches.

12 . The wearable drug delivery device of claim 1 , wherein the removal element is stainless steel, nylon, polyethylene, or polyester.

13 . The wearable drug delivery device of claim 1 , wherein the end section is a first end section which extends, beyond the perimeter of the adhesive layer and the removal element further comprises a second end section opposite the first end section that extends beyond the perimeter of the adhesive layer.

Assignments (2)
SECURITY AGREEMENT SUPPLEMENT Recorded Dec 1, 2022
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 062035/0785 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2022
From: NAZZARO, DAVID; MCLAUGHLIN, IAN; CARDINALI, STEVEN; DOUDOUMOPOULOS, ALEXANDER
To: INSULET CORPORATION
Reel/Frame 058593/0951 →
Continuity (2)
Provisional Application 63136492 · Jan 12, 2021
Related Publication 20220218898A1 · Jul 14, 2022
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