CONTROLLED DELIVERY DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS

• US 20150209505A1
• Filed: 08/29/2013
• Published: 07/30/2015
• Est. Priority Date: 08/29/2012
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Bokelman, Kevin, Hanson, Ian B, Bente, Paul F, Love, John C
• Granted Patent: US 9,987,419 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16804 Flow controllers

Abstract

A controlled delivery drive mechanism includes a drive housing, a piston, and a biasing member initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate a plunger seal and a barrel. A tether is connected between the piston and the winch drum to restrain the free expansion of the biasing member and the free axial translation of the piston upon which the biasing member bears upon. The drive mechanism may further include a gear assembly having a motor configured to drive the gear assembly to release the tether from the winch drum. The metering of the tether by the motor controls the rate or profile of drug delivery to a user. A drug delivery pump includes such a controlled delivery drive mechanism. A control system may be utilized to control the desired drug delivery rate/profile.

Claims

1. A controlled delivery drive mechanism for a drug container having a plunger seal configured to translate within a barrel, the controlled delivery drive mechanism comprising:

a drive housing;

a piston;

a biasing member, wherein the biasing member is initially retained in an energized state and is configured to bear upon an interface surface of the piston;

a tether connected at one end to the piston and at another end to a winch drum of a delivery control mechanism, wherein a tensioning force is applied to the tether to restrain the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon; and

a status reader disposed adjacent the tether, the status reader being configured to provide a signal when slack occurs in the tether.

2. The drive mechanism of claim 1 wherein the status reader applies a tensioning force to the tether.

3. The drive mechanism of claim 1 wherein the status reader may rotate about a fulcrum when the tether goes slack.

4. The drive mechanism of claim 1 wherein the status reader includes a switch.

5. The drive mechanism of claim 1, wherein the drug container contains a drug fluid within a drug chamber.

6. The drive mechanism of claim 1, wherein a cover sleeve may be utilized between the biasing member and the interface surface of the piston.

7. The drive mechanism of claim 1, wherein the tether is configured to be released from a winch drum of the delivery control mechanism to meter the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon.

8. The drive mechanism of claim 1 further comprising a gear assembly having a plurality of gears wherein at least one of said gears is configured to act as an encoder.

9. The drive mechanism of claim 1 comprising a gear assembly having a winch gear connected to a winch drum upon which the tether may be releasably wound, a worm gear engageably connected to the winch gear, a compound gear engageably connected to the worm gear, and a motor having a pinion engageably connected to the compound gear, wherein the motor is configured to drive the gear assembly to release the tether from the winch drum to meter the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon.

10. The drive mechanism of claim 7, wherein the metering of the tether by the motor controls the rate or profile of drug delivery to a user.

11. The drive mechanism of claim 1, wherein the piston is comprised of one or more parts and connects to a distal end of the tether.

12. The drive mechanism of claim 1, wherein status reader may be configured to read or recognize one or more corresponding status triggers incrementally spaced on the tether, wherein, during operation of the drive mechanism, interaction between the status reader and the status triggers transmit a signal to a power and control system to provide feedback to a user.

13. The drive mechanism of claim 12, wherein the status reader is an optical status reader and the corresponding status triggers are optical status triggers.

14. The drive mechanism of claim 12, wherein the status reader is an electromechanical status reader and the corresponding status triggers are electromechanical status triggers.

15. The drive mechanism of claim 12, wherein the status reader is a mechanical status reader and the corresponding status triggers are mechanical status triggers.

16. A drug delivery pump with controlled drug delivery comprises a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and a controlled delivery drive mechanism as claimed in claim 1.

17. The drug delivery pump of claim 16 wherein the power and control system is configured to receive one or more inputs to meter the release of the tether by the winch drum and thereby permit axial translation of the piston by the biasing member to translate a plunger seal within a barrel.

18. The drug delivery pump of claim either of claim 16, wherein the one or more inputs are provided by the user acting on the activation mechanism.

19. The drug delivery pump of claim 16, wherein the one or more inputs are provided by the user acting on a control interface.

20. The drug delivery pump of claim 16, wherein the one or more inputs are provided by the user acting on a remote control mechanism.

21. The drug delivery pump of claim 16, wherein the power and control system is configured to receive one or more inputs to adjust the restrain provided by the tether and winch drum on the free axial translation of the piston upon which the biasing member bears upon to meet a desired drug delivery rate or profile.

22. The drug delivery pump of claim 16, wherein the power and control system is configured to receive one or more inputs to adjust the restrain provided by the tether and winch drum on the free axial translation of the piston upon which the biasing member bears upon to change the dose volume for delivery to the user.

23. The drug delivery pump of claim 16, wherein the power and control system is configured to receive one or more inputs to adjust the restrain provided by the tether and winch drum on the free axial translation of the piston upon which the biasing member bears upon to start, stop, or pause operation of the drive mechanism.