Claims for Patent: 9,987,416

Summary for Patent: 9,987,416

Title:	Sterile assembled liquid medicament dosage control and delivery device
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.
Inventor(s):	McNall, III; Ralph I. (Belmont, CA), Kriesel; Joshua W. (San Francisco, CA), Joshi; Serena (San Francisco, CA), Donze; Thomas T. (San Bruno, CA)
Assignee:
Application Number:	14/593,720
Patent Claims:	1. A liquid medicament dispenser comprising: a housing and a pump carried by the housing; a medicament reservoir carried in 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 assembly comprising a first portion in which a first annular gasket is received, an opposed second portion in which a second annular gasket is received, and a barrier disposed in contact between the first and second annular gaskets, wherein the first portion is engaged with the reservoir, the second portion is fit to the tubing set, and the barrier is removable from between the annular gaskets to change the aseptic connector assembly from a storage state to a use state; in the storage state of the aseptic connector assembly, the reservoir is carried in the housing, the first portion of the aseptic connector assembly is engaged with the reservoir, the second portion of the aseptic connector assembly is fit to the tubing set, the first and second portions of the aseptic connector assembly are coupled to each other and compressed together, thereby compressing the first and second annular gaskets against each other with the barrier therebetween, and the barrier occludes the aseptic connector assembly to prevent the liquid medicament in the reservoir from moving to the sterile tubing set; and in the use state of the aseptic connector assembly, the first portion of the aseptic connector assembly is engaged with the reservoir, the second portion of the aseptic connector assembly is fit to the tubing set, the first and second portions of the aseptic connector assembly are coupled and compressed together, thereby compressing the first and second annular gaskets against each other, and the barrier is removed from the aseptic connector assembly, thereby bringing the first and second annular gaskets into direct and sealing contact with each other, coupling the reservoir and the tubing set in fluid communication, and defining a sterile passageway for the flow of the liquid medicament from the reservoir to the sterile tubing set; wherein, as the aseptic connector assembly is moved from the storage state to the use state, the first and second portions of the aseptic connector assembly remain coupled to each other and are maintained in coaxial alignment with each other. 2. The liquid medicament dispenser of claim 1, wherein a change of the aseptic connector assembly 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 assembly 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 assembly is maintained in a sterile state. 4. The liquid medicament dispenser of claim 1, wherein the barrier is carried by the aseptic connector assembly within the housing. 5. The liquid medicament dispenser of claim 1, wherein upon removal of the barrier from the aseptic connector assembly, the liquid medicament dispenser is energized. 6. The liquid medicament dispenser of claim 1, further comprising: a switch carried in the housing and coupled between a battery and the pump; in response to the aseptic connector assembly 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 1, further comprising when the barrier is removed from the aseptic connector assembly, the sterile passageway is formed through the aseptic connector assembly between the reservoir and the sterile tubing set. 8. The liquid medicament dispenser of claim 1, wherein the aseptic connector assembly further comprises: the first and second portions of the aseptic connector assembly are each formed with a bore and a seat around the respective bore; the first and second annular gaskets are each seated in the seat of the respective first and second portions; and the barrier is disposed between the first and second annular gaskets of the first and second portions of the aseptic connector assembly, respectively. 9. The liquid medicament dispenser of claim 8, wherein, in the use state of the aseptic connector assembly, the first portion of the aseptic connector assembly is engaged in an irreversible engagement with the second portion of the aseptic connector assembly, coupling the reservoir to the sterile tubing set in fluid communication. 10. The liquid medicament dispenser of claim 1, wherein the barrier extends from the aseptic connector assembly to outside of the housing. 11. The liquid medicament dispenser of claim 1, wherein the barrier includes: a first thin film bonded to the first portion of the aseptic connector assembly; and a second thin film bonded to the second portion of the aseptic connector assembly. 12. The liquid medicament dispenser of claim 11, wherein the first thin film is secured to the second thin film 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: a printed circuit board carrying circuitry; a force-sensing resistor carried on the printed circuit board; a channel is disposed over the force-sensing resistor; and the sterile tubing set extends through and is constrained by the channel against the force-sensing resistor. 16. The liquid medicament dispenser of claim 1, wherein the reservoir is filled with the liquid medicament before the reservoir is carried in the housing. 17. The liquid medicament dispenser of claim 16, wherein the reservoir comprises a syringe. 18. The liquid medicament dispenser of claim 1, wherein the liquid medicament is selected from a 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. 19. The liquid medicament dispenser of claim 1, wherein the liquid medicament is selected from a 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.

Details for Patent 9,987,416

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	05/23/1994		2039-02-26
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	09/22/1999		2039-02-26
Pfizer Inc.	ELELYSO	taliglucerase alfa	For Injection	022458	05/01/2012		2039-02-26
Takeda Pharmaceuticals U.s.a., Inc.	VPRIV	velaglucerase alfa	For Injection	022575	02/26/2010		2039-02-26
Recordati Rare Diseases, Inc.	PANHEMATIN	hemin for injection	For Injection	101246	07/20/1983		2039-02-26
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2039-02-26
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2039-02-26