Sterile Assembled Liquid Medicament Dosage Control And Delivery Device

• US 20160199568A1
• Filed: 01/09/2015
• Published: 07/14/2016
• Est. Priority Date: 01/09/2015
• Status: Active Grant

• Current Assignee: BioQ Pharma Incorporated
• Original Assignee: BioQuiddity, Inc.
• Inventors: Donze, Thomas T., McNall, Ralph I. III, Kriesel, Joshua W., Joshi, Serena
• Granted Patent: US 9,987,416 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2039/1022 additionally providing electrical connection
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A liquid medicament dispenser includes a housing and a pump carried by the housing, a reservoir applied to the housing and containing a pre-filled sterile liquid medicament, a sterile tubing set routed through the pump, a sterile administration line carried outside of the housing and coupled aseptically to the sterile tubing set in fluid communication, and an aseptic connector coupled to the reservoir and the sterile tubing set and changeable from a storage state to a use state. In the storage state, the aseptic connector prevents the liquid medicament in the reservoir from moving to the sterile tubing set. In the use state of the aseptic connector, the aseptic connector defines a sterile passageway for the flow of the liquid medicament from the reservoir to the sterile tubing set.

Claims

1. A liquid medicament dispenser comprising:

a housing and a pump carried by the housing;

a reservoir applied to the housing and containing a sterile liquid medicament;

a sterile tubing set routed through the pump;

a sterile administration line carried outside of the housing and coupled aseptically to the sterile tubing set in fluid communication;

an aseptic connector coupled to the reservoir and the sterile tubing set and changeable from a storage state to a use state;

in the storage state of the aseptic connector, the aseptic connector prevents the liquid medicament in the reservoir from moving to the sterile tubing set; and

in the use state of the aseptic connector, the aseptic connector defines a sterile passageway for the flow of the liquid medicament from the reservoir to the sterile tubing set.

2. The liquid medicament dispenser of claim 1, wherein the change of the aseptic connector from the storage state to the use state is irreversible.

3. The liquid medicament dispenser of claim 1, wherein the storage state of the aseptic connector is characterized by:

the reservoir is maintained in a sterile state;

the sterile tubing set is maintained in a sterile state; and

the aseptic connector is maintained in a sterile state.

4. The liquid medicament dispenser of claim 1, further comprising a barrier carried by the aseptic connector within the housing and configured, upon removal from the aseptic connector, to change the aseptic connector from the storage state to the use state.

5. The liquid medicament dispenser of claim 4, wherein upon removal of the barrier from the aseptic connector, the dispenser is energized.

6. The liquid medicament dispenser of claim 4, further comprising:

a switch carried in the housing and coupled between a battery and the pump;

in response to the aseptic connector changing from the storage state to the use state, the switch moves from an open state to a closed state; and

in the closed state of the switch, power is available to the pump from the battery.

7. The liquid medicament dispenser of claim 4, wherein upon removal of the barrier from the aseptic connector, a sterile passageway is formed through the aseptic connector between the reservoir and the sterile tubing set.

8. The liquid medicament dispenser of claim 4, wherein the aseptic connector comprises:

first and second portions each formed with a bore and a seat around the respective bore;

first and second gaskets, each seated in the seat of the respective first and second portions; and

the barrier is disposed between the first and second gaskets.

9. The liquid medicament dispenser of claim 8, wherein, in the use state of the aseptic connector, the first portion of the aseptic connector is engaged in an irreversible sterile engagement with the second portion of the aseptic connector, coupling the reservoir to the sterile tubing set in fluid communication.

10. The liquid medicament dispenser of claim 4, wherein the barrier extends from the aseptic connector to outside of the housing.

11. The liquid medicament dispenser of claim 4, wherein the barrier includes:

a first aseptic film bonded to the first portion of the aseptic connector; and

a second aseptic film bonded to the second portion of the aseptic connector.

12. The liquid medicament dispenser of claim 11, wherein the first aseptic film is secured to the second aseptic outside of the housing.

13. The liquid medicament dispenser of claim 1, wherein the pump is a peristaltic pump.

14. The liquid medicament dispenser of claim 1, wherein the sterile tubing set is flexible and has a compressible diameter.

15. The liquid medicament dispenser of claim 1, further comprising an occlusion detector operatively coupled to the sterile tubing set immediately upstream from an exit of the sterile tubing set through the housing.

16. The liquid medicament dispenser of claim 15, further comprising:

a control board carrying circuitry;

the occlusion detector is a pressure sensitive resistor carried on the control board;

a tunnel is disposed over the pressure sensitive resistor; and

the sterile tubing set extends through and is constrained by the tunnel against the pressure sensitive resistor.

17. The liquid medicament dispenser of claim 1, wherein the syringe is filled with the liquid medicament before the syringe is applied to the housing.

18. The liquid medicament dispenser of claim 17, wherein the reservoir comprises a syringe.

19. A liquid medicament dispenser comprising:

a housing and a pump carried by the housing;

a reservoir mounted in the housing and containing a liquid medicament;

an administration line applied to and carried outside of the housing;

a tubing set applied to the housing and connected to the sterile administration line;

an aseptic connector disposed between the reservoir and the tubing set and connecting the reservoir to the tubing set; and

a barrier carried by the aseptic connector and configured, upon removal from the aseptic connector, to couple the reservoir and the tubing set in fluid communication.

20. The liquid medicament dispenser of claim 19, wherein:

the reservoir is sterilized prior to being mounted in the housing; and

the tubing set is sterilized prior to being applied to the housing.

21. The liquid medicament dispenser of claim 19, wherein:

the aseptic connector includes first and second portions;

the first portion of the aseptic connector is coupled to the reservoir and sterilized with the reservoir prior to being mounted in the housing; and

the second portion of the aseptic connector is coupled to the tubing set and sterilized with the tubing set prior to being applied to the housing.

22. The liquid medicament dispenser of claim 19, wherein upon removal of the barrier from the aseptic connector, a sterile passageway is formed between the reservoir and the tubing set through the aseptic connector.

23. The liquid medicament dispenser of claim 19, wherein the aseptic connector comprises:

first and second portions each formed with a bore and a seat around the respective bore;

first and second gaskets, each seated in the seat of the respective first and second portions; and

the barrier is disposed between the first and second gaskets.

24. The liquid medicament dispenser of claim 23, wherein:

the first portion of the connector is coupled to the reservoir; and

the second portion of the connector is coupled to the tubing set.

25. The liquid medicament dispenser of claim 23, wherein the barrier extends from the aseptic connector to outside of the housing.

26. The liquid medicament dispenser of claim 23, wherein the barrier includes:

a first aseptic film bonded to the first portion of the aseptic connector; and

a second aseptic film bonded to the second portion of the aseptic connector.

27. The liquid medicament dispenser of claim 23, wherein the first portion of the aseptic connector is engaged in an irreversible sterile engagement with the second portion of the aseptic connector.

28. The liquid medicament dispenser of claim 19, wherein the pump is a peristaltic pump.

29. The liquid medicament dispenser of claim 19, wherein the tubing set is flexible and has a compressible diameter.

30. The liquid medicament dispenser of claim 19, further comprising an occlusion detector operatively coupled to the tubing set immediately upstream from an exit of the tubing set through the housing.

31. The liquid medicament dispenser of claim 30, further comprising:

a control board carrying circuitry;

the occlusion detector is a pressure sensitive resistor carried on the control board;

a tunnel is disposed over the pressure sensitive resistor; and

the tubing set extends through and is constrained by the tunnel against the pressure sensitive resistor.

32. The liquid medicament dispenser of claim 19, wherein the reservoir comprises a syringe.

33. The liquid medicament dispenser of claim 32, wherein the syringe is filled with the liquid medicament before the syringe is mounted to the housing.

34. A liquid medicament dispenser comprising:

a housing, a pump carried by the housing, and a sterile fluid communication path assembled in the housing;

the sterile fluid communication path includes a reservoir, an aseptic connector, and a tubing set;

the reservoir is filled with a liquid medicament and sterilized prior to being assembled into the housing;

the tubing set is sterilized separate from the reservoir prior to being assembled into the housing; and

the aseptic connector assembly connects the reservoir and the tubing set.

35. The liquid medicament dispenser of claim 34, wherein the aseptic connector includes two portions independently sterilized and fit together.

36. The liquid medicament dispenser of claim 35, wherein coupling the two portions of the aseptic connector assembly together in fluid communication energizes the dispenser.

37. The liquid medicament dispenser of claim 35, wherein:

the aseptic connector is arrangeable between a storage state and a use state;

in the storage state, the two portions of the aseptic connector are prevented from fluid communication with each other and the dispenser is prevented from being energized; and

in the use state, the two portions of the aseptic connector are aseptically coupled in fluid communication with each other and the dispenser is energized.

38. The liquid medicament dispenser of claim 37, wherein arranging the aseptic connector assembly from the storage state to the use state is irreversible.

39. The liquid medicament dispenser of claim 35, further comprising:

a barrier disposed between the two portions of the aseptic connector; and

removal of the barrier couples the two portions of the aseptic connector together in fluid communication.

40. The liquid medicament dispenser of claim 39, wherein removal of the barrier between the two portions of the aseptic connector energizes the dispenser.

41. The liquid medicament dispenser of claim 39, further comprising:

a switch carried in the housing; and

removal of the barrier from between the two portions of the aseptic connector moves the switch to a closed state in which the dispenser is energized.

42. The liquid medicament dispenser of claim 34, wherein the liquid medicament is selected from the group consisting of acetaminophen, ketamine, propofol, dexmedetomidine, fentanyl, remifentanyl, etomidate, midazolam, daptomycin, ertapenem, polymyxin B, acyclovir, amikacin, amphotericin B, chloramphenicol, cidofovir, doxycycline, erythromycin, gentamicin, quinupristin and dalfopristin, rifampin, ticarcillin and clavulanate, tobramycin, bevacizumab, trastuzumab, cyclophosphamide, filgrastim, panitumumab, cladribine, dacarbazine, infliximab, foscarnet, ganciclovir, imiglucerase, taliglucerase alfa, velaglucerase alfa, granisetron, dopamine, norepinephrine, dobutamine, milrinone, total parenteral nutrition, intravenous immunoglobulin, immune globulin, inamrinone, deferoxamine, hemin, and sodium valproate.

43. The liquid medicament dispenser of claim 34, wherein the liquid medicament is selected from the group consisting of aztreonam, trimetrexate, 5-fluorouracil, rituximab, bleomycin, cetuximab, vortezomib, gemtuzumab ozogamicin, ibritumomab tiuxetan, epirubicin, fludarabine, gemcitabine, irinotecan, oxalaplatin, paclitaxel, topotecan, vinorelbine, carboplatin, carmustine, cisplatin, daunorubicin, dexrazoxane, docetaxel, doxorubicin, etoposide, idarubicin, ifosfamide, camptosar, mitomycin, mitoxantrone, sargramostim, streptozocin, teniposide, and vinblastine.

44. A method of assembling a liquid medicament dispenser, comprising the steps of:

providing a housing, a reservoir, a tubing set, an administration line, an aseptic connector separated into upstream and downstream portions, and a pump;

coupling the upstream portion of the aseptic connector to the reservoir;

filling the reservoir with a liquid medicament;

coupling the downstream portion of the aseptic connector to the tubing set;

sterilizing together the reservoir and the upstream portion of the aseptic connector;

sterilizing together the downstream portion of the aseptic connector, the tubing set, and the administration line independently from the step of sterilizing together the reservoir and the upstream portion of the aseptic connector;

connecting the upstream portion of the aseptic connector to the downstream portion of the aseptic connector;

mounting the reservoir and the pump in the housing; and

routing the tubing set in the housing, around the pump, and through an outlet in the housing, so that the administration line extends outside of the housing.

45. The method of claim 44, wherein the step of connecting the upstream portion of the aseptic connector to the downstream portion of the aseptic connector further comprises:

providing a barrier; and

interposing the barrier between the upstream and downstream portions of the aseptic connector.

46. The method of claim 45, wherein the aseptic connector further comprises:

a first bore in the upstream portion of the aseptic connector and a first seat around the first bore;

a second bore in the downstream portion of the aseptic connector and a second seat around the second bore;

first and second gaskets, each seated in the respective first and second seats of the respective upstream and downstream portions of the aseptic connector; and

the step of interposing further comprises disposing the barrier between the first and second gaskets.

47. The method of claim 46, wherein the step of connecting the upstream portion of the aseptic connector to the downstream portion of the aseptic connector further comprises:

aligning the first and second bores, and the first and second gaskets, of the upstream and downstream portions, respectively, with each other; and

applying the upstream portion of the aseptic connector to the downstream portion of the aseptic connector with the first and second gaskets disposed therebetween, forming a sterile passageway through the aseptic connector from the reservoir to the tubing set.

48. The method of claim 45, further comprising:

providing a pull coupled to the barrier; and

routing the pull through the housing so as to extend outside of the housing.

49. The method of claim 45, wherein the barrier is irreversibly removable from the aseptic connector.

50. The method of claim 45, further comprising:

providing an electrical switch for energizing the dispenser in a closed state of the switch; and

operatively coupling the electrical switch to the barrier so that removal of the barrier from the aseptic connector places the switch in the closed state thereof.

51. The method of claim 44, further comprising the steps of:

providing a control board carrying circuitry and a pressure sensitive resistor; and

routing the tubing set against the pressure sensitive resistor.