VARIABLE RATE CONTROLLED DELIVERY DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS

• US 20150217045A1
• Filed: 08/29/2013
• Published: 08/06/2015
• Est. Priority Date: 08/29/2012
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Paul F. Bente, IV, Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Bente, Paul F. IV, Hanson, Ian B., O'Connor, Sean M., Mandes, Vincent E.
• Granted Patent: US 10,251,996 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 variable rate controlled delivery drive mechanism includes a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston. The drive mechanism may include a gear drive having one or more screws and one or more corresponding nuts. The piston contacts a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery. The biasing member is metered from free expansion from its energized state by the gear drive and a gear assembly mechanism having a motor. A drug delivery pump utilizes such variable rate controlled delivery mechanisms. A status reader configured to recognize one or more corresponding status triggers is utilized to provide feedback to a user.

Claims

1. A variable rate controlled delivery drive mechanism comprises:

a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston;

a gear drive having a gear and a substantially axial internal pass-through;

a first screw which at least partially resides within the axial internal pass-through, said first screw also having a substantially axial pass-through and an external first pitch wherein the external first pitch is configured to engage a first nut which also resides within the internal pass-through of the gear drive;

a second nut configured to engage a second screw having an external second pitch, said second nut positioned within an axial post of a piston, said axial post and second nut positioned to reside at least partially within the axial pass-through of the first screw;

wherein the piston has an interface surface adjacent to a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery, and wherein the biasing member is metered from free expansion from its energized state.

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

3. The drive mechanism of claim 1, wherein a cover sleeve may be configured to engage and slide upon the piston, between the piston and a distal end of the drive mechanism housing.

4. The drive mechanism of claim 1, wherein the first nut is rotationally constrained to the gear drive.

5. The drive mechanism of claim 1, wherein the second nut is rotationally constrained to the piston.

6. The drive mechanism of claim 1 further comprising a gear assembly mechanism having a motor, the gear assembly mechanism configured to engage gear to meter the free expansion of the biasing member from its energized state.

7. The drive mechanism of claim 6, wherein the gear assembly mechanism having a motor further comprises a pinion extending from motor;

a first compound gear having a first gear and a second gear;

a second compound gear having a first gear and a second gear; and

a trigger gear;

wherein the pinion contacts the first gear of the first compound gear, the second gear of the first compound gear contacts the first gear of the second compound gear, the second gear of the second compound gear contacts the trigger gear, and the trigger gear contacts gear to relay motion to the drive mechanism.

8. The drive mechanism of claim 1, wherein the metering of the biasing member by the motor controls the rate or profile of drug delivery to a user.

9. The drive mechanism of claim 1, wherein a status reader may be configured to read or recognize one or more corresponding status triggers, 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.

10. The drive mechanism of claim 9, wherein the status reader is an optical status reader and the corresponding status triggers are gear teeth of the trigger gear.

11. The drive mechanism of claim 9, wherein the status reader is a mechanical status reader and the corresponding status triggers are gear teeth of the trigger gear.

12. The drive mechanism of claim 9, wherein the status reader is a mechanical status reader and the corresponding status triggers are external features of the piston and/or sleeve.

13. The drive mechanism of claim 9, wherein the status reader is an optical status reader and the corresponding status triggers are external features of the piston and/or sleeve.

14. The drive mechanism of claim 1, wherein the function of the gear assembly mechanism having a motor is pre-programmed or dynamically controlled by a power and control system to meet a desired drug delivery rate or profile.

27. A drug delivery pump with a variable rate controlled delivery mechanism 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 variable rate controlled delivery drive mechanism having a drug container may be mounted, said drive mechanism of claim 1.

28. The drug delivery pump of claim 27, wherein the drug container contains a drug fluid within a drug chamber.

29. The drug delivery pump of claim 27 further comprising a gear assembly mechanism having a motor, the gear assembly mechanism configured to engage gear to meter the free expansion of the biasing member from its energized state.

30. The drug delivery pump of claim 29, wherein the gear assembly mechanism having a motor further comprises a pinion extending from motor;

a first compound gear having a first gear and a second gear;

a second compound gear having a first gear and a second gear; and

a trigger gear;

wherein the pinion contacts the first gear of the first compound gear, the second gear of the first compound gear contacts the first gear of the second compound gear, the second gear of the second compound gear contacts the trigger gear, and the trigger gear contacts gear to relay motion to the drive mechanism.

31. The drug delivery pump of claim 27, wherein the metering of the biasing member by the motor controls the rate or profile of drug delivery to a user.

32. The drug delivery pump of claim 27, wherein a status reader may be configured to read or recognize one or more corresponding status triggers, 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.

33. The drug delivery pump of claim 32, wherein the status reader is an optical status reader and the corresponding status triggers are gear teeth of the trigger gear.

34. The drug delivery pump of claim 32, wherein the status reader is a mechanical status reader and the corresponding status triggers are gear teeth of the trigger gear.

35. The drug delivery pump of claim 32, wherein the status reader is a mechanical status reader and the corresponding status triggers are external features of the piston and/or sleeve.

36. The drug delivery pump of claim 32, wherein the status reader is an optical status reader and the corresponding status triggers are external features of the piston and/or sleeve.

37. The drug delivery pump of claim 27, wherein the function of the gear assembly mechanism having a motor is pre-programmed or dynamically controlled by the power and control system to meet a desired drug delivery rate or profile.

15. A variable rate controlled delivery drive mechanism comprises:

a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston;

a gear connected to the proximal end of a drive screw having an external pitch, the external pitch is configured to engage a nut;

wherein the piston has an interface surface adjacent to a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery, and wherein the biasing member is metered from free expansion from its energized state.

16. The drive mechanism of claim 15, wherein the drug container contains a drug fluid within a drug chamber.

17. The drive mechanism of claim 15, wherein the nut is rotationally constrained to piston.

18. The drive mechanism of claim 15 further comprising a gear assembly mechanism having a motor, the gear assembly mechanism configured to engage gear to meter the free expansion of the biasing member from its energized state.

19. The drive mechanism of claim 18, wherein the gear assembly mechanism having a motor further comprises a pinion extending from motor;

a first compound gear having a first gear and a second gear;

a second compound gear having a first gear and a second gear; and

a trigger gear;

wherein the pinion contacts the first gear of the first compound gear, the second gear of the first compound gear contacts the first gear of the second compound gear, the second gear of the second compound gear contacts the trigger gear, and the trigger gear contacts gear to relay motion to the drive mechanism.

20. The drive mechanism of claim 15, wherein the metering of the biasing member by the motor controls the rate or profile of drug delivery to a user.

21. The drive mechanism of claim 15, wherein a status reader may be configured to read or recognize one or more corresponding status triggers, 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.

22. The drive mechanism of claim 21, wherein the status reader is an optical status reader and the corresponding status triggers are gear teeth of the trigger gear.

23. The drive mechanism of claim 21, wherein the status reader is a mechanical status reader and the corresponding status triggers are gear teeth of the trigger gear.

24. The drive mechanism of claim 23, wherein the status reader is a mechanical status reader and the corresponding status triggers are external features of the piston.

25. The drive mechanism of claim 23, wherein the status reader is an optical status reader and the corresponding status triggers are external features of the piston.

26. The drive mechanism of claim 15, wherein the function of the gear assembly mechanism having a motor is pre-programmed or dynamically controlled by a power and control system to meet a desired drug delivery rate or profile.