Claims for Patent: 9,044,378

Summary for Patent: 9,044,378

Title:	Anti-needle stick safety device or system for use with drugs requiring reconstitution
Abstract:	The present disclosure describes a needle guard device or system that can be used with drugs requiring reconstitution. The needle guard is preferably a passive needle guard that can be used during reconstitution without activating the safety mechanism. Following administration of the medication, the needle guard shields a user from inadvertent needle sticks by extending a protective shield over the needle.
Inventor(s):	Verespej; James M. (San Marcos, CA), Westbye; Lars T. (Carlsbad, CA), Dowds; Philip (San Diego, CA)
Assignee:	SAFETY SYRINGES, INC. (Carlsbad, CA)
Application Number:	12/129,459
Patent Claims:	1. A syringe system for administering lyophilized drugs, the syringe system comprising a needle guard, the needle guard comprising a shield; a body; one or more trigger fingers disposed on a proximal region of the body or shield; one or more catches disposed on the body or shield, wherein the catches are configured to retain the trigger fingers in a resting, latched position and the shield in a first, retracted position until the trigger fingers are unlatched; and a spring, wherein the spring is configured to bias the shield to move from the first, retracted position to a second, extended position if the trigger fingers are unlatched; a syringe removably coupled with the body of the needle guard, the syringe including a cylindrical barrel, a port extending from the distal, administration end of the barrel, and a plunger slidably coupled with the cylindrical barrel, wherein the port is positioned adjacent the distal end of the shield and a needle is couplable to the port and extendible beyond the shield when the shield is in the first, retracted position, wherein the plunger comprises a stem and a thumb pad on the proximal end of the stem, wherein the stem and thumb pad are configured to enable the thumb pad to contact and unlatch the trigger fingers when the plunger is advanced to a distal position within the barrel of the syringe during reconstitution of a drug within the syringe and injection of a drug within the syringe into a patient; and a component removably coupled to the port of the syringe and configured to retain the shield in the first, retracted position when the trigger fingers are unlatched as the thumb pad moves distally and contacts the trigger fingers as the plunger is advanced to a distal position within the barrel of the syringe during reconstitution of a drug within the syringe, wherein the component is dimensioned to abut the distal end of the shield, and wherein the trigger fingers are relatchable to the resting, latched position to retain the shield in a first, retracted position when the thumb pad moves out of contact with the trigger fingers as the plunger is withdrawn proximally during reconstitution of a drug within the syringe, and wherein the trigger fingers are biased to relatch to the resting position when the component is attached to the port and the thumb pad is withdrawn proximally to disengage from contact with the trigger fingers. 2. The system of claim 1, wherein the cylindrical barrel is filled with a diluent. 3. The syringe system of claim 2, wherein the diluent comprises sterile water. 4. The syringe system of claim 2, wherein the diluent comprises saline. 5. The syringe system of claim 1, wherein the port comprises a luer port. 6. The syringe system of claim 1, wherein the component comprises a luer connector. 7. The syringe system of claim 1, wherein the component comprises a vial adaptor. 8. The syringe system of claim 1, wherein the port is configured to receive a needle. 9. The syringe system of claim 7, wherein the vial adaptor comprises a sharp distal end. 10. The syringe system of claim 7, wherein the proximal end of the vial adaptor comprises a luer fitting. 11. The syringe system of claim 7, wherein the vial adaptor comprises panels configured to receive a vial bottle. 12. A syringe system for administering lyophilized drugs, the syringe system comprising a needle guard, the needle guard comprising a shield; a body; one or more trigger fingers disposed on a proximal region of the body or shield; one or more catches disposed on the body or shield, wherein the catches are configured to retain the trigger fingers in a resting, latched position and the shield in a first, retracted position until the trigger fingers are unlatched; and a spring, wherein the spring is configured to bias the shield to move from the first, retracted position to a second, extended position if the trigger fingers are; a syringe removably coupled with the body of the needle guard, the syringe including a cylindrical barrel, a port extending from the distal, administration end of the barrel, and a plunger slidably coupled with the cylindrical barrel wherein the port is positioned adjacent the distal end of the shield and a needle is couplable to the port and extendible beyond the shield when the shield is in the first, retracted position, wherein the plunger comprises a stem and a thumb pad on the proximal end of the stem, wherein the stem and thumb pad are configured to enable the thumb pad to contact and unlatch the trigger fingers when the plunger is advanced to a distal position within the barrel of the syringe during reconstitution of a drug within the syringe and injection of a drug within the syringe into a patient, a component removably coupled to the port of the syringe and configured to retain the shield in the first, retracted position when the trigger fingers are unlatched as the thumb pad moves distally and contacts the trigger fingers as the plunger is advanced to a distal position within the barrel of the syringe during reconstitution of a drug within the syringe, wherein the component is dimensioned to abut the distal end of the shield, wherein the trigger fingers are relatchable to the resting, latched position to retain the shield in a first, retracted position when the thumb pad moves out of contact with the trigger fingers as the plunger is withdrawn proximally during reconstitution of a drug within the syringe, and wherein the trigger fingers are biased to relatch to the resting position when the component is attached to the port and the thumb pad is withdrawn proximally to disengage from contact with the trigger fingers; and a back plate removably coupled with the proximal portion of the needle guard, the back plate including an aperture configured to receive the stem of the plunger and to prevent removal of the plunger from the barrel. 13. The syringe system of claim 12, wherein the port comprises a luer port. 14. The syringe system of claim 12, wherein the component comprises a luer connector. 15. The syringe system of claim 12, wherein the component comprises a vial adaptor. 16. The syringe system of claim 12, wherein the port is configured to receive a needle.

Details for Patent 9,044,378

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2027-05-31