Sterile patch pump

Patent metadata

Field	Value
Publication number	US-2019015584-A1
Application number	US-201816134691-A
Country	US
Kind code	A1
Filing date	Sep 18, 2018
Priority date	Jul 7, 2015
Publication date	Jan 17, 2019
Grant date	—

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

1 . A method for subcutaneous drug delivery, the method comprising:
pushing, by a patient, a start button;
responsive to the pushing, concurrently:
puncturing, by a fluid path needle integral to the start button, a sterile drug barrier of a sterile drug assembly and a septum of a drug container, wherein the drug container stores a sterile biologic;
disengaging, by a declined ramp of the start button, a carrier arm of a carrier to trigger a primary spring of needle insertion mechanism to release stored potential energy; and
contacting, by a triggering post integral to the start button, a sterile electronic barrier of the sterile drug assembly to activate a triggering switch of an electronic circuit board;

responsive to the puncturing:
establishing a fluid pathway from the drug container;

responsive to the disengaging:
moving 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;
inserting a cannula of the carrier into the patient;
uncoupling the carrier and the needle hub assembly by forcing the release tabs to contact separators;
removing a needle of the needle hub assembly from the cannula by moving the needle hub assembly away from the patient using potential energy released by a secondary spring when the carrier uncouples the needle hub; and
establishing a fluidic connection between the
cannula and the fluid pathway; and responsive to the contacting:
supplying, by the electronic circuit, a signal to a pressurization system of a non -sterile assembly;

generating, by the pressurization system, a pressurizing gas based on the signal, wherein the pressurizing gas forces the sterile biologic from the drug container through the fluid path and the cannula into the patient.

2 . The method 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 method 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 method of claim 1 , further comprising:
removing, by the patient, a removable safety prior to the pushing of the start button, wherein the removable safety inhibits the patient from pressing the start button unless the removable safety is removed.

5 . The method of claim 1 , further comprising:
displaying, by one or more visual indicators of the sterile assembly, one or more indications of an operational status of the electronic circuit board.

6 . The method of claim 1 , further comprising:
affixing, by the patient, a base of a combined assembly to the patient, wherein the base of the combined assembly is made of a material with a low thermal conductivity and the combined assembly includes the sterile assembly and the non-sterile assembly.

7 . The method of claim 1 , further comprising:
storing in a memory of the electronic circuit a time and a date when the patient administered the biologic.

8 . The method of claim 1 , further comprising:
monitoring, by a pressure sensor, a pressure in the drug container; and determining, by the electronic circuit, the signal based on the pressure sensor.

9 . The method of claim 1 , wherein further responsive to the pushing, concurrently:
locking 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 locking the start button so that it cannot be pressed again.

10 . The method of claim 1 , further comprising:
affixing, by the patient, an adhesive liner of a combined assembly to the patient, wherein the combined assembly includes the sterile assembly and the non-sterile assembly.

Assignees

• Flextronics Ap Llc

Inventors

• Meehan Connor
• Patel Lopa

Classifications

• A61M2005/14252

  with needle insertion means · CPC title

• A61M2005/2474

  with movable piercing means, e.g. ampoule remains fixed or steady · CPC title

• A61M2205/123

  with incorporated reservoirs · CPC title

• A61M5/155

  pressurised by gas {introduced into the reservoir} · CPC title

• A61M5/14526

  the piston being actuated by fluid pressure · CPC title