Claims for Patent: 11,771,841

Summary for Patent: 11,771,841

Title:	Systems and methods for mixing syringe valve assemblies
Abstract:	A syringe mixing system is provided for housing and mixing contents between at least two syringes. In some embodiments, a syringe coupler is provided that receives first and second syringes and includes a valve member that is convertible between a closed position and an open position. Retention systems for preventing or inhibiting removal of at least one syringe after use are also provided.
Inventor(s):	James Sherman, Casey Dean, Carl Hart, John Bingham, Hossam Aboudagher
Assignee:	Tolmar International Ltd
Application Number:	US17/854,769
Patent Claims:	1. A syringe-to-syringe mixing system comprising: a first syringe comprising a hollow body, the hollow body having a proximal end and a distal dispensing end; a second syringe comprising a hollow body, the second syringe comprising a distal dispensing end; the first syringe and the second syringe each comprising a barrel and a plunger for applying pressure to a syringe content; a valve assembly that is operable to receive the first syringe and the second syringe, and wherein the valve assembly comprises at least one resilient member that is biased toward a locked position; wherein the valve assembly comprises a displaceable member comprising a user-interface and a guide member, wherein the displaceable member is slidable relative to the guide member, and wherein the user-interface is operable to receive a force from a user and transmit the force to a displaceable seal, and wherein the displaceable seal is moveable in a direction substantially perpendicular to a longitudinal axis of at least one of the first syringe and the second syringe; a selectively rotatable member operable to receive at least one of the first syringe and the second syringe; wherein the valve assembly comprises a first position wherein a fluid flow between the first syringe and the second syringe through the displaceable seal is fully occluded, and a second position in which fluid is allowed to flow through the displaceable seal and between the first syringe and the second syringe; wherein the displaceable member comprises at least one projection in communication with the selectively rotatable member when the displaceable member is in the first position, and wherein the at least one projection is spaced apart from the selectively rotatable member when the displaceable member is in the second position and the selectively rotatable member is freely rotatable when the displaceable member is in the second position. 2. The syringe-to-syringe mixing system of claim 1, wherein at least one of the first syringe and the second syringe is moveable with the valve assembly. 3. The syringe-to-syringe mixing system of claim 1, wherein one of the first syringe and the second syringe comprises a drug and wherein the other syringe comprises a liquid formulation component. 4. The syringe-to-syringe mixing system of claim 1, wherein at least one of the first syringe and the second syringe comprise leuprolide acetate. 5. The syringe-to-syringe mixing system of claim 1, wherein the selectively rotatable member comprises a threaded member operable to receive at least one of the first syringe and the second syringe. 6. The syringe-to-syringe mixing system of claim 1, wherein the syringe-to-syringe mixing system houses a pharmaceutical composition and the pharmaceutical composition comprises about 7.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone and a 50:50 poly(lactic acid-co-glycolic acid) (PLGA) copolymer having a weight average molecular weight from about 31 kDa to about 45 kDa and at least one terminal carboxylic acid end group as the liquid formulation component. 7. The syringe-to-syringe mixing system of claim 1, wherein the syringe-to-syringe mixing system houses a pharmaceutical composition and the pharmaceutical composition comprises about 22.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and end groups that are hydroxyl-terminated as the liquid formulation component. 8. The syringe-to-syringe mixing system of claim 1, wherein syringe-to-syringe mixing system houses a pharmaceutical composition and the pharmaceutical composition comprises about 30 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 9. The syringe-to-syringe mixing system of claim 1, wherein syringe-to-syringe mixing system houses a pharmaceutical composition and the pharmaceutical composition comprises about 45 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and an 85:15 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 20 kDa to about 26 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 10. A syringe-to-syringe mixing system comprising: a first syringe comprising a hollow body defining an internal chamber, the hollow body having a proximal end and a distal dispensing end with an outlet; a second syringe comprising a hollow body defining an internal chamber, the hollow body of the second syringe having a proximal end and a distal dispensing end with an outlet; the first syringe and the second syringe each comprising a plunger slidably disposed within the syringe for applying pressure to a syringe content; a syringe coupler that is operable to receive the first syringe and the second syringe; the syringe coupler comprising a displaceable member slidably engaged with a guide member, wherein the displaceable member comprises a seal with a flow port that is offset from the outlet of at least one of the first syringe and the second syringe when the displaceable member is provided in a first position, wherein the flow port is aligned with the outlet of the first syringe and the second syringe when the displaceable member is provided in a second position, and wherein the displaceable member comprises at least one resilient projection and the guide member comprises at least one recess for receiving the at least one resilient projection; and wherein the at least one resilient projection is operable to be displaced upon movement of the displaceable member and wherein the at least one resilient projection prevents or inhibits the displaceable member from being returned to the first position when the at least one resilient projection is provided in the at least one recess of the guide member. 11. The syringe-to-syringe mixing system of claim 10, wherein the syringe coupler comprises a user-interface operable to receive a force from a user and transmit the force to the seal. 12. The syringe-to-syringe mixing system of claim 10, wherein the displaceable member is displaceable relative to the guide member in a direction that is substantially perpendicular to a longitudinal axis of at least one of the first syringe and the second syringe. 13. The syringe-to-syringe mixing system of claim 10, wherein the syringe coupler comprises a rotatable Luer lock member that is free to rotate within the syringe coupler when the displaceable member is provided in the second position. 14. The syringe-to-syringe mixing system of claim 10, wherein at least one of the first syringe and the second syringe comprise leuprolide acetate. 15. The syringe-to-syringe mixing system of claim 10, wherein the at least one resilient projection comprises first and second resilient projections that are biased toward a locked position and the guide member comprises first and second recesses for receiving the resilient projections in the second position.