Sterile patch pump

Patent metadata

Field	Value
Publication number	US-10080837-B2
Application number	US-201615742398-A
Country	US
Kind code	B2
Filing date	Jul 7, 2016
Priority date	Jul 7, 2015
Publication date	Sep 25, 2018
Grant date	Sep 25, 2018

Abstract

An apparatus and method for the aseptic delivery of a biologic medication in a wearable form factor. The apparatus and method allow for standard off-the-shelf drug cartridges to be utilized without compromising the sterility of the biologic. Further, by utilizing a two part assembly, manufacturing costs are minimized.

First claim

What is claimed is:

1. A device for subcutaneous drug delivery, the device comprising:
a sterilized assembly; and
a non-sterilized assembly that is mechanically coupled to sterilized assembly to form a combined assembly;
wherein the sterilized assembly includes:
a start button,
a sterile drug barrier,
a sterile electronic barrier, and
a needle insertion mechanism mechanically coupled to the start button that comprises a carrier and primary spring;
wherein the non-sterilized assembly includes:
a pressurization system,
a drug container that houses a sterile biologic, and
electronic circuitry that includes a triggering switch;
wherein, responsive to being pressed by a patient, the start button:
punctures the sterile drug barrier with a fluid path needle integral to the start button,
punctures a septum of the drug container with the fluid path needle, and
establishes a fluid pathway;
wherein, responsive to being pressed by the patient, the start button further:
contacts the sterile electronic barrier with a triggering post integral to the start button, and
activates the triggering switch;
wherein, responsive to being pressed by the patient, the start button further:
moves a flat portion of the start button relative to a carrier arm to engage a declined ramp of the start button with the carrier arm, and
disengages the declined ramp to trigger the primary spring to release stored potential energy;
wherein, responsive to the triggering of the primary spring, the needle insertion mechanism:
moves the carrier and a needle hub assembly in a direction towards the patient, wherein the carrier and the needle hub assembly are coupled by release tabs,
inserts a cannula of the carrier into the patient,
uncouples the carrier and the needle hub assembly by forcing the release tabs to contact separators, and
fluidically connects the cannula to the fluid pathway;
wherein, responsive to the uncoupling of the carrier, the needle hub assembly:
releases the potential energy stored in a secondary spring, and
removes a needle from within the cannula by moving the needle hub assembly away from the patient;
wherein, responsive to the activation of the triggering switch, the electronic circuit:
supplies a signal to the pressurization system; and
wherein the pressurization system:
generates a pressurizing gas, in response to the signal, that forces the sterile biologic from the drug container through the fluid path and the cannula into the patient.

2. The device of claim 1 , wherein the pressurization system contains one or more hydrogen generators;
wherein the one or more hydrogen generators generate the pressurizing gas in proportion to the signal supplied by the electronic circuit; and
wherein the electronic circuit:
determines the signal to obtain a desired flow rate of sterile biologic based upon a user flow control switch.

3. The device of claim 1 , wherein the sterilized assembly further includes a drug viewing window; and
wherein the drug viewing window enables the patient to view the drug container.

4. The device of claim 1 , wherein the sterilized assembly further includes a removable safety; and
wherein the removable safety is inserted into the start button and inhibits the patient from pressing the start button unless the removable safety is removed.

5. The device of claim 1 , wherein the sterilized assembly further includes one or more visual indicators that display one or more indications of an operational status of the device.

6. The device of claim 1 , wherein the sterilized assembly further includes a base that is in contact with the patient and is made of a material with a low thermal conductivity.

7. The device of claim 1 , wherein the electronic circuit further includes a memory; and
wherein the memory stores information a time and a date when the patient administered the biologic.

8. The device of claim 1 , wherein the non-sterilized assembly further includes a pressure sensor that monitors a pressure in the drug container; and
wherein the electronic circuit determines the signal based on the pressure sensor.

9. The device of claim 1 , wherein, responsive to being pressed by the patient, the start button further:
locks the carrier in a position so that the cannula is held in position by a mechanical force in addition to a force provided by the primary spring; and
locks the start button so that it cannot be pressed again.

10. The device of claim 1 , wherein the sterilized assembly further includes a base that is in contact with the patient and the base includes an adhesive liner that affixes the combined assembly to the patient.

Assignees

• Flextronics Ap Llc
• Flextronics Ap Llc

Inventors

• Meehan Connor
• Patel Lopa

Classifications

• A61M2005/14252

  with needle insertion means · CPC title

• A61M2205/123

  with incorporated reservoirs · CPC title

• A61M5/14248 Primary

  of the skin patch type · CPC title

• A61M2005/1585

  Needle inserters · CPC title

• A61M2005/14268

  with a reusable and a disposable component · CPC title