Sterile fluid pathway connection to drug containers for drug delivery pumps

• US 10,369,274 B2
• Filed: 07/17/2017
• Issued: 08/06/2019
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: UNL Holdings, LLC
• Inventors: O'Connor, Sean M., Hanson, Ian B., Bente, IV, Paul F., Ramaswamy, Rajan, Codd, Daniel S., Beaver, Scott W., Bokelman, Kevin L., Love, John C.
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/651,807
• Publication Number:
  US 20180008769A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

A user-initiated fluid pathway connection includes: a connection hub, a piercing member, a sterile sleeve, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the piercing member is initially retained within the sterile sleeve between the connection hub and the pierceable seal of the drug container. The connection hub may include an internal aperture within the connection hub which functions as a flow restrictor and wherein a piercing member is connected to one end of the internal aperture and a fluid conduit is connected to another end of the internal aperture. A drug delivery pump with integrated sterility maintenance features includes a housing, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection as described above, a power and control system, and a drive mechanism connected to a drug container are mounted. Methods of assembly and operation are also provided.

Claims

1. A fluid pathway connection comprising:

a drug container including

a barrel having a proximal end and a distal end,

a pierceable seal disposed at the proximal end of the barrel, and

a cap disposed at the proximal end of the barrel;

a piercing member;

a fluid conduit;

a connection hub, the piercing member being connected to the connection hub; and

a sterile sleeve, one end of the sterile sleeve being fixedly coupled to the connection hub and an opposing end of the sterile sleeve being fixedly coupled to a proximal end of the drug container, the piercing member being disposed within a sterile environment defined by the sterile sleeve, the connection hub, and the pierceable seal, the piercing member being disposed between the connection hub and the pierceable seal of the drug container in an initial unactivated position,

wherein the pierceable seal and the connection hub are adapted for relative movement between the initial unactivated position wherein the piercing member does not pierce the pierceable seal, and an activated position wherein the piercing member extends through the pierceable seal, the sterile sleeve being compressible or collapsible and adapted to compress or collapse as the connection hub and the pierceable seal are moved relatively between the initial unactivated position and the activated position, the piercing member being maintained in the sterile environment during movement from the initial unactivated position to the activated position.

2. The fluid pathway connection of claim 1, wherein the drug container further includes a plunger seal.

3. The fluid pathway connection of claim 1, wherein the pierceable seal has a seal barrier configured to be penetrated by the piercing member.

4. The fluid pathway connection of claim 3, wherein the piercing member is initially disposed within the pierceable seal and in contact with, or adjacent to, the seal barrier.

5. The fluid pathway connection of claim 1, wherein the piercing member extends through the connection hub.

6. The fluid pathway connection of claim 5, wherein the fluid conduit is fluidly coupled to the piercing member opposite the pierceable seal.

7. The fluid pathway connection of claim 1, wherein the sterile sleeve is a pre-formed aspect of the pierceable seal.

8. The fluid pathway connection of claim 1, wherein the sterile sleeve is connected to the connection hub by engagement between hub connectors of the sterile sleeve and corresponding sleeve connectors of the connection hub.

9. The fluid pathway connection of claim 1, further including an activation mechanism.

10. The fluid pathway connection of claim 9, wherein the activation mechanism includes a button.

11. The fluid pathway connection of claim 9, wherein the activation mechanism is disposed along an axis of the connection hub.

12. The fluid pathway connection of claim 11, wherein displacement of the activation mechanism by a user causes displacement of the connection hub to cause the piercing member to penetrate the pierceable seal.

13. The fluid pathway connection of claim 11, wherein the connection hub is disposed along an axis of the barrel.

14. The fluid pathway connection of claim 1, wherein the connection hub is disposed along an axis of the barrel.

15. The fluid pathway connection of claim 14, wherein the connection hub, the piercing member, and the barrel are substantially coaxially disposed.

16. The fluid pathway connection of claim 1, wherein the connection hub includes an internal aperture, the piercing member and the fluid conduit being fluidly connected at opposite ends of the internal aperture of the connection hub, the internal aperture having at least one of:

a smaller internal diameter than the fluid conduit to restrict the flow of a drug fluid passing therethrough, and

a circuitous or tortuous path within the connection hub to extend a fluid pathway through the internal aperture.

17. A drug delivery pump with integrated sterility maintenance features comprising:

the fluid pathway connection of claim 2;

a housing;

an assembly platform;

an activation mechanism disposed on the assembly platform;

an insertion mechanism disposed on the assembly platform;

a power and control system disposed on the assembly platform; and

a drive mechanism disposed on the assembly platform, the drive mechanism initially coupled to the drug container or adapted to be coupled to the drug container.

18. The drug delivery pump of claim 17, wherein the drug container contains a drug fluid.

19. The drug delivery pump of claim 17, wherein the piercing member, the pierceable seal and the barrel are substantially coaxially disposed.

20. The drug delivery pump of claim 17, wherein the piercing member, the pierceable seal and the activation mechanism are substantially coaxially disposed.

21. A fluid pathway connection comprising:

a drug container including

a barrel having a proximal end and a distal end,

a pierceable seal disposed at the proximal end of the barrel, and

a cap disposed at the proximal end of the barrel;

a piercing member;

a fluid conduit;

a connection hub, the piercing member being connected to the connection hub; and

a sterile sleeve, one end of the sterile sleeve being fixedly coupled to the connection hub and an opposing end of the sterile sleeve being fixedly coupled to a proximal end of the drug container, the sterile sleeve being a pre-formed aspect of the pierceable seal, the piercing member being disposed within the sterile sleeve between the connection hub and the pierceable seal of the drug container in an initial unactivated position,

wherein the pierceable seal and the connection hub are adapted for relative movement between the initial unactivated position wherein the piercing member does not pierce the pierceable seal, and an activated position wherein the piercing member extends through the pierceable seal, the sterile sleeve being compressible or collapsible and adapted to compress or collapse as the connection hub and the pierceable seal are moved relatively between the initial unactivated position and the activated position.

22. A drug delivery pump with integrated sterility maintenance features comprising:

a fluid pathway connection including;

a drug container including;

a barrel having a proximal end and a distal end,

a pierceable seal disposed at the proximal end of the barrel, and

a cap disposed at the proximal end of the barrel;

a piercing member;

a fluid conduit;

a connection hub, the piercing member being connected to the connection hub; and

a sterile sleeve, one end of the sterile sleeve being fixedly coupled to the connection hub and an opposing end of the sterile sleeve being fixedly coupled to a proximal end of the drug container, the piercing member being disposed within the sterile sleeve between the connection hub and the pierceable seal of the drug container in an initial unactivated position,

wherein the pierceable seal and the connection hub are adapted for relative movement between the initial unactivated position wherein the piercing member does not pierce the pierceable seal, and an activated position wherein the piercing member extends through the pierceable seal, the sterile sleeve being compressible or collapsible and adapted to compress or collapse as the connection hub and the pierceable seal are moved relatively between the initial unactivated position and the activated position;

a housing;

an assembly platform;

an activation mechanism disposed on the assembly platform;

an insertion mechanism disposed on the assembly platform;

a power and control system disposed on the assembly platform; and

a drive mechanism disposed on the assembly platform, the drive mechanism initially coupled to the drug container or adapted to be coupled to the drug container.

23. The drug delivery pump of claim 22, wherein the drug container contains a drug fluid.

24. The drug delivery pump of claim 22, wherein the piercing member, the pierceable seal and the barrel are substantially coaxially disposed.

25. The drug delivery pump of claim 22, wherein the piercing member, the pierceable seal and the activation mechanism are substantially coaxially disposed.