Unified drug mixer and dispenser

• US 9,775,946 B2
• Filed: 02/11/2016
• Issued: 10/03/2017
• Est. Priority Date: 02/11/2016
• Status: Active Grant

• Current Assignee: BioQ Pharma Incorporated
• Original Assignee: BioQ Pharma Incorporated
• Inventors: McNall, III, Ralph I., Donze, Thomas T., MacDonell, Andrew M., Joshi, Serena
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): BUI, ANH T
• Application Number:
  US15/041,157
• Publication Number:
  US 20170232187A1
• Time in Patent Office: 600 Days
• Field of Search: 604 82- 86
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/202 Separating means
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: B65D 55/06 Deformable or tearable wires, strings, or strips containers specially constructed to be opened by tear-strips, strings or the like B65D17/00; caps or cap-like closures with tear-strips B65D41/32; Use of seals , e.g. destructible locking pins B65D55/022 takes precedence
• CPC Class Codes: B65D 55/066 Foil covers combined with outer closures and comprising interacting or interposed tamper indicating means visible through the outer closure, e.g. releasable coloured dyes, changeable patterns, pierceable membranes, visible through a transparent closure or through a window

Abstract

A unified dispenser for holding, mixing, and dispensing a drug includes a housing holding a diluent reservoir, a drug reservoir, and a tubing set connecting and defining a fluid communication path therebetween. A first occlusion is at the diluent reservoir, and a second occlusion is at the drug reservoir. In a storage state of the dispenser, the first and second occlusions are entirely encased within the housing and occlude the fluid communication path. First and second pull assemblies extend outside the housing. The first and second pull assemblies are coupled to the first and second occlusions, respectively, so that removal of the first and second pull assemblies removes the first and second occlusions and joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, thereby arranging the dispenser from the storage state to a use state.

Claims

1. A unified dispenser for holding, mixing, and dispensing a drug, the dispenser comprising:

a housing holding a diluent reservoir for containing a diluent, a drug reservoir for containing a drug, and a tubing set connecting and defining a fluid communication path therebetween;

a first aseptic connector encasing a first occlusion, and a second aseptic connector encasing a second occlusion;

the first aseptic connector is located at the diluent reservoir and the second aseptic connector is located at the drug reservoir;

in a storage state of the dispenser, the first and second occlusions are entirely encased within the housing and occlude the fluid communication path; and

first and second pull assemblies, each extending to outside the housing;

wherein the first and second pull assemblies extend into the first and second aseptic connectors and include the first and second occlusions, respectively, so that removal of the first and second pull assemblies removes the first and second occlusions from the first and second aseptic connectors, respectively, joins the diluent reservoir to the tubing set in fluid communication, joins the drug reservoir to the tubing set in fluid communication, and joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, thereby arranging the dispenser from the storage state to a use state.

2. The dispenser of claim 1, wherein removal of one of the first and second occlusions energizes the dispenser.

3. The dispenser of claim 1, further comprising:

a pump assembly; and

energy storage means;

wherein removal of one of the first and second occlusions electrically couples the pump assembly to the energy storage means.

4. The dispenser of claim 3, wherein:

within the use state, the dispenser further has a mix state and a dispense state;

in the mix state, the pump assembly operates in a first direction to mix the diluent with the drug; and

in the dispense state, the pump assembly operates in a second direction different from the first direction to dispense a mixture of the diluent and the drug.

5. The dispenser of claim 1, further comprising:

the first aseptic connector comprises an upper first aseptic connector mated to a lower first aseptic connector; and

the second aseptic connector comprises an upper second aseptic connector mated to a lower second aseptic connector.

6. The dispenser of claim 5, wherein:

the upper first aseptic connector is coupled to the diluent reservoir, the lower first aseptic connector is coupled to the tubing set, the upper second aseptic connector is coupled to the drug reservoir, and the lower second aseptic connector is coupled to the tubing set;

the first occlusion comprises an upper first ribbon and a lower first ribbon in the first aseptic connector;

the second occlusion comprises an upper second ribbon and a lower second ribbon in the second aseptic connector; and

in the storage state, the upper first, lower first, upper second, and lower second aseptic connectors are occluded by the upper first, lower first, upper second, and lower second ribbons, respectively.

7. The dispenser of claim 6, wherein:

in the storage state, the upper and lower first ribbons are against each other between the upper and lower first aseptic connectors;

in the storage state, the upper and lower second ribbons are against each other between upper and lower second aseptic connectors;

removal of the first pull assembly defines the upper and lower first aseptic connectors as a diluent aseptic connector assembly, having a sterile bore therethrough from the diluent reservoir to the tubing set; and

removal of the second pull assembly defines the upper and lower second aseptic connectors as a drug aseptic connector assembly, having a sterile bore therethrough from the drug reservoir to the tubing set.

8. The dispenser of claim 7, wherein the first and second aseptic connectors each include valve means for controlling a directional flow of the diluent through the first and second aseptic connectors.

9. The dispenser of claim 1, wherein removal of the first and second occlusions is irreversible.

10. A unified dispenser for holding, mixing, and dispensing a drug, the dispenser comprising:

a housing holding energy storage means, a pump assembly, a diluent reservoir, a drug reservoir, and a tubing set connecting and defining a fluid communication path between the diluent reservoir and the drug reservoir;

a first aseptic connector encasing a first occlusion, and a second aseptic connector encasing a second occlusion, the first and second aseptic connectors disposed within the housing;

the first aseptic connector is located at the diluent reservoir and the second aseptic connector is located at the drug reservoir;

in a storage state of the dispenser, the first and second occlusions are entirely encased within the housing and occlude the fluid communication path; and

first and second pull assemblies, each extending to outside the housing, configured to remove the first and second occlusions, respectively;

wherein removal of the first and second pull assemblies removes the first and second occlusions from the first and second aseptic connectors, respectively, joins the diluent reservoir to the tubing set in fluid communication, joins the drug reservoir to the tubing set in fluid communication, joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, and electrically couples the pump assembly to the energy storage means, thereby arranging the dispenser from the storage state to a use state.

11. The dispenser of claim 10, wherein removal of one of the first and second occlusions energizes the dispenser.

12. The dispenser of claim 10, wherein removal of the first and second pull assemblies joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set and electrically couples the pump assembly to the energy storage means simultaneously.

13. The dispenser of claim 10, further comprising:

the first aseptic connector comprises an upper first aseptic connector mated to a lower first aseptic connector; and

the second aseptic connector comprises an upper second aseptic connector mated to a lower second aseptic connector.

14. The dispenser of claim 13, wherein:

the upper first aseptic connector is coupled to the diluent reservoir, the lower first aseptic connector is coupled to the tubing set, the upper second aseptic connector is coupled to the drug reservoir, and the lower second aseptic connector is coupled to the tubing set;

the first occlusion comprises an upper first ribbon and a lower first ribbon in the first aseptic connector;

the second occlusion comprises an upper second ribbon and a lower second ribbon in the second aseptic connector; and

in the storage state, the upper first, lower first, upper second, and lower second aseptic connectors are occluded by the upper first, lower first, upper second, and lower second ribbons, respectively.

15. The dispenser of claim 14, wherein:

in the storage state, the upper and lower first ribbons are against each other between the upper and lower first aseptic connectors;

in the storage state, the upper and lower second ribbons are against each other between upper and lower second aseptic connectors;

removal of the first pull assembly defines the upper and lower first aseptic connectors as a diluent aseptic connector assembly, having a sterile bore therethrough from the diluent reservoir to the tubing set; and

removal of the second pull assembly defines the upper and lower second aseptic connectors as a drug aseptic connector assembly, having a sterile bore therethrough from the drug reservoir to the tubing set.

16. The dispenser of claim 10, wherein:

within the use state, the dispenser further has a mix state and a dispense state;

in the mix state, the pump assembly operates in a first direction to mix the diluent with the drug; and

in the dispense state, the pump assembly operates in a second direction different from the first direction to dispense a mixture of the diluent and the drug.

17. A unified dispenser for holding, mixing, and dispensing a drug, the dispenser comprising:

a housing holding energy storage means, a pump assembly, a diluent reservoir containing a diluent, a drug reservoir containing a drug, a tubing set connecting and defining a fluid communication path between the diluent reservoir and the drug reservoir, and an administration line;

a first aseptic connector encasing a first occlusion, and a second aseptic connector encasing a second occlusion;

the first aseptic connector is located at the diluent reservoir and the second aseptic connector is located at the drug reservoir;

the first and second occlusions are entirely encased within the housing;

a storage state, a mix state, and a dispense state of the dispenser;

in the storage state of the dispenser, the first and second occlusions occlude the fluid communication path, the drug is maintained in the drug reservoir by and against the second occlusion, and the diluent is maintained in the diluent reservoir by and against the first occlusion;

in the mix state of the dispenser, the first and second occlusions are removed, and the pump assembly communicates the diluent from the diluent reservoir to the drug reservoir to mix the diluent with the drug reservoir; and

in the dispense state of the dispenser, the pump assembly dispenses a mixture of the diluent and the drug out of the administration line.

18. The dispenser of claim 17, wherein removal of the first and second occlusions arranges the dispenser out the storage state in preparation for the mix state.

19. The dispenser of claim 17, wherein the dispenser is configured to irreversibly move from the storage state to the mix state.

20. The dispenser of claim 17, wherein removal of the first and second occlusions electrically couples the pump assembly to the energy storage means.

21. The dispenser of claim 17, further comprising:

the first aseptic connector comprises an upper first aseptic connector mated to a lower first aseptic connector; and

the second aseptic connector comprises an upper second aseptic connector mated to a lower second aseptic connector.

22. The dispenser of claim 21, wherein:

the upper first aseptic connector is coupled to the diluent reservoir, the lower first aseptic connector is coupled to the tubing set, the upper second aseptic connector is coupled to the drug reservoir, and the lower second aseptic connector is coupled to the tubing set;

the first occlusion comprises an upper first ribbon and a lower first ribbon in the first aseptic connector;

the second occlusion comprises an upper second ribbon and a lower second ribbon in the second aseptic connector; and

in the storage state, the upper first, lower first, upper second, and lower second aseptic connectors are occluded by the upper first, lower first, upper second, and lower second ribbons, respectively.

23. The dispenser of claim 22, wherein:

in the storage state, the upper and lower first ribbons are against each other between the upper and lower first aseptic connectors;

in the storage state, the upper and lower second ribbons are against each other between upper and lower second aseptic connectors;

removal of the first pull assembly defines the upper and lower first aseptic connectors as a diluent aseptic connector assembly, having a sterile bore therethrough from the diluent reservoir to the tubing set; and

removal of the second pull assembly defines the upper and lower second aseptic connectors as a drug aseptic connector assembly, having a sterile bore therethrough from the drug reservoir to the tubing set.

24. The dispenser of claim 17, wherein:

in the mix state, the pump assembly operates in a first direction o mix the diluent with the drug; and

in the dispense state, the pump assembly operates in a second direction different from the first direction to dispense a mixture of the diluent and the drug.

25. The dispenser of claim 17, wherein the drug is selected from the group consisting of vancomycin, cefazolin, cefoxitin, ceftriaxone, linezolid, ampicillin, azithromycin, cefepime, veftazidime, cefuroxime, oxacillin, meropenem, cefotaxime, gentamicin, tobramycin, cimetidine, cefazolin, cefoxitin, ampicillin, clindamycin, cefepime, caspofungin, cefotetan, meropenem, tobramycin, primaxin, quinupristin and dalfopristin, rifampin, cladribine, thiotepa, taliglucerase alfa, velaglucerase alfa, ivig, hemin, trastuzumab, cyclophosphamide, lyophilized cytoxan, endoxan, procytox, cycloblastin, dacarbazine, plicamycin, trimetrexate, mitomycin, sargramostim, bendamustine, bortezomib, gemtuzumab ozogamicin, fludarabine, gemcitabine, carmustine, dacarbazine, dexrazoxane, doxorubicin, etoposide, ifosfamide, and pembrolizumab.

26. The dispenser of claim 17, wherein the drug is selected from the group consisting of dolasetron, labetolol, dobutamine, bevacizumab, filgrastim, panitumumab, dacarbazine, docetaxel, mitoxantrone, sargramostim, teniposide, rituximab, cetuximab, gemtuzumab ozogamicin, irinotecan, oxaliplatin, paclitaxel, topotecan, vinorelbine, carboplatin, cisplatin, dacarbazine, doxorubicin, idarubicin, oxaliplatin, nivolumab, docetaxel, paclitaxel, ferumoxytol, dexmedetomedine, taxanes, and cabazitaxel.

27. The dispenser of claim 17, wherein the drug is selected from the group consisting of pidilizumab, ipilimumab, anti-PD1, anti-PD-L1, durvalumab, avelumab, atezolizumab, anti-OX40, anti-4-1BB, anti-GITR, anti-TIM2, anti-LAG3, anti-TNFRSF25, anti-ICOS, light-activated drugs for tumor ablation, anti-EGFR, anti-TGFbeta, IDO and TDO inhibitors, kynurenine inhibitors, and cleavage enzymes, inhibitors of the tryptophan metabolic pathway, anti-phosphatidylserine antibody-drug conjugates containing a tumor-targeting moiety and a cytotoxic moiety, bi-specific antibodies or proteins containing targets present on tumor cells and T cells, or on tumor cells and B cells, or on tumor cells and other lymphocytes, or on T cells and antigen-presenting cells, anti-VEGF, BTK inhibitors, RAS inhibitors, MET inhibitors, and combinations of at least two of the above agents.