Integrated pierceable seal fluid pathway connection and drug containers for drug delivery pumps

• US 9,737,655 B2
• Filed: 08/22/2014
• Issued: 08/22/2017
• Est. Priority Date: 08/23/2013
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Clemente, Matthew J., Hanson, Ian B., Bente, IV, Paul F.
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US14/466,403
• Publication Number:
  US 20150057613A1
• Time in Patent Office: 1,096 Days
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump

Abstract

A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.

Claims

1. A sterile fluid pathway assembly comprising

a sterile fluid container;

a sterile fluid conduit; and

a sterile fluid connector comprising

a first portion configured to connect the sterile fluid conduit; and

a second portion configured to mount the sterile fluid container;

a connector hub;

a pierceable seal disposed at least partially between the connector hub and a sterile fluid chamber of the sterile fluid container, the pierceable seal in sealing contact with the connector hub to form a sterile cavity between the connector hub and the pierceable seal; and

a piercing member fixedly disposed within the connector hub capable of providing a sterile fluid communication between the sterile fluid chamber and the sterile fluid conduit;

wherein at least a portion of the pierceable seal is configured to transform from a non-activated state wherein the pierceable seal is intact, to an activated state wherein the pierceable seal is disrupted by the piercing member to create a sterile fluid communication between the sterile fluid chamber of the sterile fluid container and the sterile fluid conduit; and

wherein the sterile fluid container comprises a plunger seal and translation of the plunger seal results in relative motion of the pierceable seal and the piercing member.

2. The sterile fluid pathway assembly of claim 1, wherein the pierceable seal is further configured to recess a portion of the sterile cavity within the sterile fluid container.

3. The sterile fluid pathway assembly of claim 1, wherein the connector hub further comprises at least one port.

4. The sterile fluid pathway assembly of claim 1, wherein the plunger seal is configured to engage the connector hub in the activated state to minimize residual fluid in the sterile fluid container.

9. The sterile fluid pathway assembly of claim 1, wherein relative motion of the pierceable seal and the piercing member causes the pierceable seal to transform from the non-activated state to the activated state.

10. The sterile fluid pathway assembly of claim 1, wherein the position of at least a portion of the pierceable seal is fixed with respect to the sterile fluid container.

11. The sterile fluid pathway assembly of claim 1, wherein a portion of the pierceable seal abuts an end of the sterile fluid container.

5. An infusion pump device comprising

an insertion mechanism;

and

a sterile fluid pathway assembly comprising

a sterile fluid container;

a sterile fluid conduit; and

a sterile fluid connector comprising

a first portion configured to connect the sterile fluid conduit; and

a second portion comprising a housing configured to mount a sterile fluid container;

a connector hub;

a pierceable seal disposed at least partially between the connector hub and a sterile fluid chamber of the sterile fluid container, the pierceable seal in sealing contact with the connector hub to form a sterile cavity between the connector hub and the pierceable seal; and

a piercing member fixedly disposed within the connector hub, capable of providing a sterile fluid communication between the sterile fluid chamber and the sterile fluid conduit;

wherein at least a portion of the pierceable seal is configured to transform from a non-activated state wherein the pierceable seal is intact, to an activated state wherein the pierceable seal is disrupted by the piercing member to create a sterile fluid communication between the sterile fluid chamber of the sterile fluid container and the sterile fluid conduit; and

wherein the sterile fluid container comprises a plunger seal and translation of the plunger seal results in relative motion of the pierceable seal and the piercing member;

wherein actuation of the drive mechanism causes fluid movement from the sterile fluid container through the sterile fluid pathway assembly to the insertion mechanism.

6. The infusion pump device of claim 5, wherein the pierceable seal is further configured to recess a portion of the sterile cavity within the sterile fluid container.

7. The infusion pump device of claim 5, wherein the connector hub of the sterile fluid connector further comprises at least one port.

8. The infusion pump device of claim 5, wherein the plunger seal is configured to engage the connector hub in the activated state to minimize residual fluid in the sterile fluid container.

12. The infusion pump of claim 5, wherein relative motion of the pierceable seal and the piercing member causes the pierceable seal to transform from the non-activated state to the activated state.

13. The infusion pump of claim 5, wherein the position of at least a portion of the pierceable seal is fixed with respect to the sterile fluid container.