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

• US 9,802,030 B2
• Filed: 03/12/2013
• Issued: 10/31/2017
• Est. Priority Date: 01/25/2013
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: UNL Holdings, LLC
• Inventors: Clemente, Matthew J., Hanson, Ian B., Bente, IV, Paul F., Agard, Ryan M., Ciccarelli, Nicholas J.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza
• Application Number:
  US13/796,156
• Publication Number:
  US 20140213975A1
• Time in Patent Office: 1,694 Days
• Field of Search: 604131-135, 604143, 604148, 604151-155
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence

Abstract

A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

Claims

1. An integrated fluid pathway connection and drug container comprising:

the drug container including;

a barrel,

a plunger seal disposed within the barrel, and

a pierceable seal integrated at least partially within the drug container,

the barrel, the plunger seal, and the pierceable seal defining a drug chamber retaining a drug fluid,

a seal mount coupled to the pierceable seal, the seal mount having a connection rim;

a biasing member configured to exert a pressure on the plunger seal; and

the integrated fluid pathway connection including;

a piercing member including a proximal end and a distal end,

a connection hub, the piercing member being disposed through the connection hub, the connection hub comprising one or more connection prongs configured to engage the connection rim of the seal mount to prevent relative translation of the pierceable seal away from the connection hub,

a fluid conduit in fluid communication with the distal end of the piercing member,

the piercing member and pierceable seal including a first configuration and a second configuration,

wherein, in the first configuration, the proximal end of the piercing member is disposed at least partially distally to the pierceable seal within a sterile cavity between the connection hub and the pierceable seal, and the drug fluid is not delivered to the piercing member,

wherein, in the second configuration, the piercing member extends through the pierceable seal, and the drug fluid is delivered to the piercing member, and

wherein a relative movement between the pierceable seal and the piercing member from the first configuration to the second configuration is caused by a force applied by the drug fluid on the pierceable seal in response to a force applied by the biasing member.

2. The integrated fluid pathway connection and drug container of claim 1 wherein the connection hub includes a connection post, the piercing member extending from the connection post, the sterile cavity being formed between the piercing member, the connection post, and the pierceable seal.

3. The integrated fluid pathway connection and drug container of claim 2 wherein the pierceable seal and the connection post and piercing member are disposed for the relative movement from the first configuration to the second configuration.

4. The integrated fluid pathway connection and drug container of claim 2, wherein the one or more connection prongs of the connection hub are integrally formed with the connection post and wherein the connection post is disposed at least partially within an inner bore of the seal mount.

5. The integrated fluid pathway connection and drug container of claim 1, wherein penetration of the pierceable seal by the piercing member upon the relative movement between the pierceable seal and the piercing member from the first configuration to the second configuration opens a fluid pathway through the pierceable seal and the piercing member to the fluid conduit.

6. The integrated fluid pathway connection and drug container of claim 1, wherein the piercing member is disposed through the connection hub and connects to the fluid conduit.

7. The integrated fluid pathway connection and drug container of claim 1 further comprising one or more interconnects and one or more corresponding contacts to transmit a signal to a user.

8. The fluid pathway connection and drug container of claim 7, wherein the one or more interconnects are within or at least partially proximal to the plunger seal within the drug container such that the piercing member is capable of penetrating the plunger seal and acting as a contact for the one or more interconnects to transmit a signal to the user.

9. The fluid pathway connection of claim 7, wherein one of either the one or more interconnects and the one or more corresponding contacts is within or at least partially proximal to the plunger seal within the drug container, and the other of the one or more interconnects and the one or more corresponding contacts is within or at least partially distal to the pierceable seal to transmit the signal to the user when the plunger seal and the pierceable seal are substantially in contact.

10. The fluid pathway connection and drug container of claim 7, wherein the one or more interconnects and the one or more corresponding contacts are selected from the group consisting of Hall effect sensors;

giant magneto resistance (GMR) or magnetic field sensors;

optical sensors;

capacitive or capacitance change sensors;

ultrasonic sensors; and

linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and

combinations thereof, which are capable of coordinating to transmit the signal to the user.

11. The integrated fluid pathway connection and drug container of claim 1, further comprising one or more flow restrictors.

12. The integrated fluid pathway connection and drug container of claim 1, wherein the pierceable seal has a seal barrier, the piercing member being initially in contact with, or adjacent to, the seal barrier.

13. The integrated fluid pathway connection and drug container of claim 1, wherein the connection hub has a header with a conduit port, a chamber of the connection hub, and a vacuum port with a channel that leads into the chamber such that the sterile cavity is capable of being evacuated through the channel.

14. The integrated fluid pathway connection and drug container of claim 13, wherein the conduit port is configured to have a membrane to permit fluid flow out of the chamber of the connection hub and the vacuum port is capable of being plugged.

15. The integrated fluid pathway connection and drug container of claim 1, further comprising a filter in contact with the connection hub, the filter being selected from the group consisting of permeable membranes, semi-permeable membranes, and porous membranes.

16. A drug delivery pump with integrated sterility maintenance features comprises:

a housing,

an activation mechanism,

an insertion mechanism,

a drive mechanism, and

the integrated fluid pathway connection and drug container of claim 1, the drug container connected at one end to the drive mechanism,

the activation mechanism, the insertion mechanism, the drive mechanism, and the integrated fluid pathway connection and drug container being mounted within the housing.

17. The drug delivery pump of claim 16, further comprising one or more interconnects and one or more corresponding contacts, wherein the pierceable seal is translatable upon a connection post of the connection hub and is further configured to move from the second configuration, where the pierceable seal has been penetrated by the piercing member, to a third configuration the one or more interconnects and the one or more corresponding contacts are permitted to transmit a signal to a user.

18. The drug delivery pump of claim 17, wherein one of either the one or more interconnects and the one or more corresponding contacts is upon an aspect of a drive mechanism and the other of the one or more interconnects and the one or more corresponding contacts is within or at least partially proximal to the plunger seal to transmit the signal to the user when the plunger seal and the pierceable seal are substantially in contact.

19. The drug delivery pump of claim 17, wherein one of either the one or more interconnects and the one or more corresponding contacts is within or at least partially distal to the pierceable seal and the other of the one or more interconnects and the one or more corresponding contacts is proximal to the connection hub to transmit the signal to the user when the plunger seal and the pierceable seal are substantially in contact.

20. The drug delivery pump of claim 17, wherein the one or more interconnects and the one or more corresponding contacts are selected from the group consisting of Hall effect sensors;

giant magneto resistance (GMR) or magnetic field sensors;

optical sensors;

capacitive or capacitance change sensors;

ultrasonic sensors; and

linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and

combinations thereof, which are capable of coordinating to transmit the signal to the user.

21. The drug delivery pump of claim 17, wherein the one or more interconnects and the one or more corresponding contacts are configured such that either:

a) one of either the one or more interconnects and the one or more corresponding contacts is upon an aspect of the drive mechanism and the other of the one or more interconnects and the one or more corresponding contacts is within or at least partially proximal to the plunger seal to transmit the signal to the user when the plunger seal and the pierceable seal are substantially in contact;

or

b) one of either the one or more interconnects and the one or more corresponding contacts is within or at least partially distal to the pierceable seal and the other of the one or more interconnects and the one or more corresponding contacts is proximal to the connection hub to transmit the signal to the user when the plunger seal and the pierceable seal are substantially in contact.