Claims for Patent: 10,406,278

Summary for Patent: 10,406,278

Title:	Unified drug mixer and dispenser
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.
Inventor(s):	McNall, III; Ralph I. (Belmont, CA), Donze; Thomas T. (San Bruno, CA), MacDonell; Andrew M. (San Francisco, CA), Joshi; Serena (San Francisco, CA)
Assignee:
Application Number:	15/687,393
Patent 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 occlusion at the diluent reservoir and a second occlusion 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 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. 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 a power source; wherein removal of one of the first and second occlusions electrically couples the pump assembly to the power source. 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: first and second aseptic connectors in the fluid communication path; and the first and second aseptic connectors include the first and second occlusions, respectively. 6. The dispenser of claim 5, 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. 7. The dispenser of claim 6, 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 ribbon, respectively. 8. The dispenser of claim 7, 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 passageway 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 passageway therethrough from the drug reservoir to the tubing set. 9. The dispenser of claim 8, wherein the tubing set includes valve means for controlling a directional flow of the diluent through the tubing set. 10. The dispenser of claim 1, wherein removal of the first and second occlusions is irreversible. 11. A unified dispenser for holding, mixing, and dispensing a drug, the dispenser comprising: a housing holding a power source, 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 occlusion at the diluent reservoir and a second occlusion 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, joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, and electrically couples the pump assembly to the power source, thereby arranging the dispenser from the storage state to a use state. 12. The dispenser of claim 11, wherein removal of one of the first and second occlusions energizes the dispenser. 13. The dispenser of claim 11, 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 power source simultaneously. 14. The dispenser of claim 11, further comprising: first and second aseptic connectors in the fluid communication path; and the first and second aseptic connectors include the first and second occlusions, respectively. 15. The dispenser of claim 14, 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. 16. The dispenser of claim 15, 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 ribbon, respectively. 17. The dispenser of claim 16, 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 passageway 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 passageway therethrough from the drug reservoir to the tubing set. 18. The dispenser of claim 11, 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. 19. A unified dispenser for holding, mixing, and dispensing a drug, the dispenser comprising: a housing holding a power source, 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 occlusion at the diluent reservoir and a second occlusion 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, and the diluent is maintained in the diluent reservoir; 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. 20. The dispenser of claim 19, wherein removal of the first and second occlusions arranges the dispenser out the storage state in preparation for the mix state. 21. The dispenser of claim 19, wherein the dispenser is configured to irreversibly move from the storage state to the mix state. 22. The dispenser of claim 19, wherein removal of the first and second occlusions electrically couples the pump assembly to the power source. 23. The dispenser of claim 19, further comprising: first and second aseptic connectors in the fluid communication path; and the first and second aseptic connectors include the first and second occlusions, respectively. 24. The dispenser of claim 23, 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. 25. The dispenser of claim 24, 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 ribbon, respectively. 26. The dispenser of claim 25, 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 passageway 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 passageway therethrough from the drug reservoir to the tubing set. 27. The dispenser of claim 19, wherein: 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. 28. The dispenser of claim 19, 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. 29. The dispenser of claim 19, 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. 30. The dispenser of claim 19, 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.

Details for Patent 10,406,278

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Pfizer Inc.	ELELYSO	taliglucerase alfa	For Injection	022458	May 01, 2012	10,406,278	2036-02-11
Takeda Pharmaceuticals U.s.a., Inc.	VPRIV	velaglucerase alfa	For Injection	022575	February 26, 2010	10,406,278	2036-02-11
Recordati Rare Diseases, Inc.	PANHEMATIN	hemin for injection	For Injection	101246	July 20, 1983	10,406,278	2036-02-11
Amgen Inc.	NEUPOGEN	filgrastim	Injection	103353	February 20, 1991	10,406,278	2036-02-11