Wearable medication delivery device

• US 10,413,665 B2
• Filed: 11/22/2016
• Issued: 09/17/2019
• Est. Priority Date: 11/25/2015
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Rioux, Robert, Nazzaro, David
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/358,945
• Publication Number:
  US 20170143900A1
• Time in Patent Office: 1,029 Days
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14272 for emergency, field or home use, e.g. self-contained kits to be carried by the doctor
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/0272 Electro-active or magneto-active materials
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14216 : Reciprocating piston type
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/14526 : the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Systems and methods for delivering a medication to a person experiencing an emergency medical event without requiring intervention or action on the part of the person. A device encases a reservoir of medication and a delivery mechanism. Sensors in the housing sense a physical attribute of the person and circuitry monitors information collected by the sensors to determine if the person is experiencing a severe medical condition or event based on the information. An input device on or in the housing, such as a button, may be used or activated by the person if the detected condition or event is a false positive to cancel further action. If the system does not include the button or if the user does not press it in time, the system activates the delivery device and injects the medication into the person.

Claims

1. A wearable medication delivery device, comprising:

an environmental sensor configured to detect a condition of a surrounding environment occupied by a user based on sampling air in the surrounding environment;

a controller coupled to the environmental sensor, and configured to determine that the user is experiencing a medical event based on the condition of the surrounding environment detected by the environmental sensor;

a reservoir of medication; and

a needle actuator coupled to the reservoir and to the controller, the needle actuator configured to inject a needle into the user in response to the controller determining the user is experiencing the medical event, wherein the medication is subsequently dispensed from the reservoir to the user through the needle,

wherein the needle actuator further comprises;

a spring;

a needle driver coupled to the spring at a first end of the needle driver and coupled to the needle at a second, opposite end of the needle driver;

a first key having a first protrusion positioned in a first opening of the needle driver, the first key and the first opening positioned on a first side of the needle driver;

a second key having a second protrusion positioned in a second opening of the needle driver, the second key and the second opening positioned on a second, opposite side of the needle driver; and

an electrically deformable material disposed around the needle driver and positioned through a first hole in the first key and positioned through a second hole in the second key,

wherein;

the needle driver is under load of the spring, and the first and second keys restrict movement of the needle driver when the first protrusion is positioned in the first opening of the needle driver and the second protrusion is positioned in the second opening of the needle driver,

when the controller determines the user is experiencing the medical event, the controller is further configured to cause the electrically deformable material to change shape, and

in response to the electrically deformable material changing shape, the first protrusion of the first key is released from the first opening of the needle driver and the second protrusion of the second key is released from the second opening of the needle driver, thereby allowing the spring to expand and propel the needle driver in a direction to cause the needle to inject the user.

2. The wearable medication delivery device of claim 1, further comprising a housing having an outer surface in direct physical contact with the user.

3. The wearable medication delivery device of claim 2, wherein the outer surface further comprises an adhesive for attaching the wearable medication delivery device to the user.

4. The wearable medication delivery device of claim 1, further comprising a motion sensor.

5. The wearable medication delivery device of claim 4, the motion sensor is configured to detect a motion of the user.

6. The wearable medication delivery device of claim 1, wherein the condition of the surrounding environment being a presence of a gas.

7. The wearable medication delivery device of claim 6, wherein the gas is sarin gas.

8. There wearable medication delivery device of claim 7, wherein the medical event is an exposure to a chemical warfare weapon.

9. The wearable medication delivery device of claim 1, wherein the controller is further configured to provide an alarm to the user prior to causing the needle actuator to inject the needle into the user.

10. The wearable medication delivery device of claim 9, wherein the alarm is a visual alarm.

11. The wearable medication delivery device of claim 9, wherein the alarm is an audible alarm.

12. The wearable medication delivery device of claim 9, wherein the alarm includes vibrating a portion of the wearable medication delivery device.

13. The wearable medication delivery device of claim 9, further comprising an override button, wherein the user presses the override button in response to the alarm to prevent the needle actuator from injecting the needle into the user.

14. The wearable medication delivery device of claim 1, wherein the needle driver comprises the reservoir of medication.

15. The wearable medication delivery device of claim 1, wherein the needle driver comprises a fluid conduit coupling the reservoir of medication to the needle.

16. The wearable medication delivery device of claim 1, wherein the electrically deformable material changes shape by having a diameter of the electrically deformable material increase.

17. A method of delivering a medication to a user from a wearable medication device directly attached to the user, comprising:

receiving information from an environmental sensor configured to sample air in a surrounding environment of the user;

determining the user is experiencing a medical event based on the received information from the sensor, the medical event comprising an exposure to a toxic gas;

providing an alarm to the user indicating that the user is experiencing the medical event; and

in response to the user failing to press an override button within a predetermined amount time from when the alarm is provided, injecting a needle into the user and dispensing the medication from a reservoir to the user through the needle, otherwise if the user presses the override button within the predetermined amount of time, preventing injection of the needle into the user,

wherein injecting the needle into the user includes activating a needle actuator coupled to the needle, wherein the needle actuator comprises;

a spring;

a needle driver coupled to the spring at a first end of the needle driver and coupled to the needle at a second, opposite end of the needle driver;

a first key having a first protrusion positioned in a first opening of the needle driver, the first key and the first opening positioned on a first side of the needle driver;

a second key having a second protrusion positioned in a second opening of the needle driver, the second key and the second opening positioned on a second, opposite side of the needle driver; and

an electrically deformable material disposed around the needle driver and positioned through a first hole in the first key and positioned through a second hole in the second key,

wherein;

the needle driver is under load of the spring, and the first and second keys are configured to restrict movement of the needle driver when the first protrusion is positioned in the first opening of the needle driver and the second protrusion is positioned in the second opening of the needle driver,

when the controller determines the user is experiencing the medical event the controller causes the electrically deformable material to change shape, and

in response to the electrically deformable material changing shape, the first protrusion of the first key is released from the first opening of the needle driver and the second protrusion of the second key is released from the second opening of the needle driver, thereby allowing the spring to expand and to propel the needle driver in a direction to cause the needle to inject the user.

18. The method of claim 17, wherein the toxic gas is sarin gas.

19. The method of claim 17, further comprising receiving medical condition information of the user from a medical condition sensor.

20. The method of claim 17, further comprising receiving motion information of the user from a motion sensor.