Insertion mechanism for a drug delivery pump

• US 9,511,189 B2
• Filed: 08/30/2012
• Issued: 12/06/2016
• Est. Priority Date: 09/02/2011
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: O'Connor, Sean M., Decker, Robert, Shetty, Gautam N., DeStefano, Mark A., Hanson, Ian B., Bente, Paul F. IV
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R
• Application Number:
  US13/599,727
• Publication Number:
  US 20130060233A1
• Time in Patent Office: 1,559 Days
• Field of Search: 604/151, 604/156, 604/157, 604/164.01, 604/164.04, 604/164.06, 604/164.07, 604/164.08, 604/164.12, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.

Claims

1. An insertion mechanism for a drug pump, said insertion mechanism comprising:

an insertion mechanism housing having an internal chamber;

a manifold guide having an upper chamber and a lower chamber separated by a manifold guide ring;

one or more insertion biasing members initially held in an energized state within the internal chamber of insertion mechanism housing between the housing and the manifold guide ring;

a clip flexibly engaged with the upper chamber of the manifold guide;

a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide;

a manifold, a septum and a cannula, an annular space within the manifold between the septum and the cannula defines a manifold header, the manifold having a manifold wall including a manifold intake defining a fluid pathway through the manifold wall into the manifold header.

2. The insertion mechanism of claim 1, wherein the insertion mechanism comprises two insertion biasing members.

3. The insertion mechanism of claim 1, wherein the manifold intake is adapted to be connected to a fluid conduit.

4. The insertion mechanism of claim 1 further comprising a base connected to a distal end of the insertion mechanism housing.

5. The insertion mechanism of claim 1 further comprising a sterile boot fixedly connected at one end to the manifold and at the other end to a base connected to a distal end of the insertion mechanism housing, the sterile boot providing an interior space.

6. The insertion mechanism of claim 1 further comprises one or more guide protrusions extending from a proximal end of the insertion mechanism housing into the internal chamber.

7. The insertion mechanism of claim 6, wherein the manifold guide ring has one or more pass-throughs which correspond with the guide protrusions, wherein the manifold guide is slidably engaged with the housing by interaction between the pass-throughs and the guide protrusions.

8. The insertion mechanism of claim 7, wherein the manifold guide is maintained in rotational alignment by interaction between the pass-throughs and the guide protrusions.

9. The insertion mechanism of claim 1 further comprising a ferrule which maintains the cannula in a fixed and sealed position within the manifold.

10. The insertion mechanism of claim 1, wherein the clip has one or more arms, each arm having a release surface and a lockout surface.

11. The insertion mechanism of claim 10 further including one or more guide protrusions extending from a proximal end of the insertion mechanism housing into the internal chamber, and wherein in an initial locked configuration the release surfaces engage the hub to maintain the retraction biasing member in an energized state;

and, in a retracted configuration the release surfaces disengage the hub to permit de-energizing of the retraction biasing member, thereby retracting the hub and the needle, wherein the lockout surfaces engage the distal ends of the guide protrusions to prevent proximal travel of the manifold guide.

12. A drug delivery pump with integrated safety features comprises a housing and an assembly platform, upon which an activation mechanism, a drive mechanism, a fluid pathway connection, a power control system, and an insertion mechanism may be mounted, the activation mechanism being disposed for selective activation to activate the insertion mechanism, said insertion mechanism comprising:

an insertion mechanism housing having an internal chamber;

a manifold guide having an upper chamber and a lower chamber separated by a manifold guide ring;

one or more insertion biasing members initially held in an energized state within the internal chamber of insertion mechanism housing between the housing and the manifold guide ring;

a clip flexibly engaged with the upper chamber of the manifold guide;

a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide;

a manifold having a septum and a cannula, an annular space within the manifold between the septum and the cannula defines a manifold header, the manifold having a manifold wall including a manifold intake defining a fluid pathway through the manifold wall into the manifold header; and

a base for connection of the insertion mechanism to the assembly platform.

13. The drug delivery pump of claim 12, wherein the insertion mechanism comprises two insertion biasing members.

14. The drug delivery pump of claim 12, wherein the manifold intake is adapted to be connected to a fluid conduit.

15. The drug delivery pump of claim 12 further comprising a sterile boot fixedly connected at one end to the manifold and at the other end to the base to form an interior space.

16. The drug delivery pump of claim 12 further comprising a control arm disposed between the activation mechanism and the insertion mechanism, the control arm adapted to transfer motion from the activation mechanism to the insertion mechanism as a result of activation of the activation mechanism, the drug delivery pump further including a fluid conduit for fluid transfer between the fluid pathway connection and the insertion mechanism.

17. The drug delivery pump of claim 12 further comprising one or more guide protrusions extending from a proximal end of the insertion mechanism housing into the internal chamber.

18. The drug delivery pump of claim 17, wherein the manifold guide ring has one or more pass-throughs which correspond with the guide protrusions, wherein the manifold guide is slidably engaged with the housing by interaction between the pass-throughs and the guide protrusions.

19. The drug delivery pump of claim 18, wherein the manifold guide is maintained in rotational alignment by interaction between the pass-throughs and the guide protrusions.

20. The drug delivery pump of claim 12, wherein the clip has one or more arms, each arm having a release surface and a lockout surface, wherein in an initial locked configuration the release surfaces engage the hub to maintain the retraction biasing member in an energized state;

and, in a retracted configuration the release surfaces disengage the hub to permit de-energizing of the retraction biasing member, thereby retracting the hub and the needle, wherein the lockout surfaces engage the distal ends of the guide protrusions to prevent proximal travel of the manifold guide.