Claims for Patent: 6,358,236

Summary for Patent: 6,358,236

Title:	Device for reconstituting medicaments for injection
Abstract:	A device is provided for reconstituting a lyophilized or powdered medicament such as blood factor VIII which must be reconstituted just prior to use, such as by introduction of a sterile fluid from a syringe, which comprises a housing having an upper section capable of receiving a syringe and a lower section capable of receiving a vial containing the medicament in co-axial alignment with the syringe, a middle section connecting the upper and lower sections which has a central aperture which forms a passageway for fluid transfer between the syringe and the vial, and a hollow vented spike which extends downwardly from the central aperture for a length sufficient to ensure that the lower end of the spike will pierce the seal and enter the interior of a vial housed in the lower section of the device. The invention is advantageous because the vented opening in the spike will allow for an equalization of the pressure after the piercing of the vial by the spike which will facilitate the use of the device. In addition, the device also features an ergonomic design which maximizes the safety and efficiency of the reconstitution of important medicaments such as blood factors, and allows for easily manipulation of the device by patients such as those with Factor VIII deficiency who may suffer from related physical ailments which limit their dexterity.
Inventor(s):	DeFoggi; John Mark (Waukegan, IL), Bilstad; Arnold (Deerfield, IL), McPhilliamy; Ingrid (Chicago, IL)
Assignee:	Baxter International Inc. (Deerfield, IL)
Application Number:	09/129,898
Patent Claims:	1. A reconstitution device for use in reconstituting a powdered medicament contained in a sterilized sealed vial prior to injection into a patient comprising: (a) a housing having an upper section with an opening in its upper end capable of receiving a syringe, a lower section with an opening capable of receiving and housing a vial and maintaining the vial in roughly co-axial alignment with a syringe housed in said upper section; (b) a middle section connecting said upper and lower sections of said housing having a central aperture which provides a passageway for the transfer of fluid between said upper and lower sections of said housing; and (c) a hollow elongated slotted spike extending downwardly from said central aperture for a length sufficient to ensure that the lower end of the spike will pierce the top of a sealed vial when said vial is housed in the lower section of said housing, said slot extending from a point at the lower end of the spike to a point near the base of the spike so as to allow (i) rapid pressure equalization in the vial when the spike pierces the seal of the vial; and (ii) drainage of reconstituted medicament when the device is inverted so as to dispense the reconstituted medicament from the vial into the syringe. 2. A reconstitution device according to claim 1 wherein the interior surface of said upper section is roughly cylindrical. 3. A reconstitution device according to claim 1 further comprising ribs on the interior surface of said upper section. 4. A reconstitution device according to claim 1 wherein the lower end of said lower section is flanged. 5. A reconstitution device according to claim 1 further comprising a means to retain a syringe in the upper section of said housing. 6. A reconstitution device according to claim 5 wherein said means to retain a syringe in the upper section of said housing comprises a luer fitting. 7. A reconstitution device according to claim 1 further comprising a filter disposed along the passageway of fluid between the vial and the syringe. 8. A reconstitution device according to claim 7 wherein the pore size of said filter is in the range of from about 80 microns to about 160 microns. 9. A reconstitution device according to claim 7 wherein the filter is comprised of a material selected from the group consisting of nylon and polyester. 10. A reconstitution device according to claim 1 which is comprised of a sterilizable plastic material. 11. A reconstitution device according to claim 10 wherein the device is comprised of a material selected from the group consisting of polycarbonates, acrylics and acrylic butyl styrene. 12. A reconstitution device according to claim 1 which is comprised of a transparent plastic material. 13. A reconstitution device according to claim 1 which is comprised of an opaque plastic material. 14. A reconstitution device according to claim 1 wherein the lower section has openings to allow visual assessment of the positioning of the hollow vented spike. 15. A reconstitution device according to claim 1 wherein the lower section of said housing is of a length so that the bottom end of said lower section does not extend to the bottom of a vial which is housed in the lower section. 16. A reconstitution device according to claim 1 further comprising a tip protector which is positioned over the hollow vented spike prior to use. 17. A reconstitution device according to claim 1 wherein the lower end of said lower section is flared so that the exterior opening of the lower section is larger in diameter than the inner end of said lower section. 18. A reconstitution device according to claim 1 wherein the lower section is of a size which will receive a vial having a volume in the range of from about 10 ml to about 50 ml. 19. A reconstitution device according to claim 1 wherein the lower section will receive a vial having a volume of about 30 ml. 20. A reconstitution device according to claim 1 in combination with a syringe housed in said upper section of said housing. 21. A reconstitution device according to claim 20 in which the syringe comprises a glass barrel encased in a plastic sheath. 22. A reconstitution device according to claim 20 further comprising a cannula having a blunt end which faces the reconstitution device and a sharp end which faces the interior of the syringe, and a stoppered compartment containing a sterile fluid which is pierced by the sharp end of the cannula prior to use. 23. A reconstitution device according to claim 20 which is sterilized prior to use. 24. A reconstitution device according to claim 20 further comprising a tip protector covering the hollow vented spike of the lower section of said housing. 25. A reconstitution device according to claim 20 further comprising tamper-evident packaging which alerts the user if the syringe has previously been separated from the reconstitution device. 26. A reconstitution device according to claim 1 in combination with a vial housed in said lower section of said housing. 27. A reconstitution device according to claim 1 in combination with a syringe housed in said upper section of said housing and a vial housed in said lower section of said housing. 28. A method of reconstituting a medicament contained in a sterilized sealed vial comprising the steps of: (a) providing a syringe containing a sterile fluid capable of reconstituting a medicament; (b) providing a reconstitution device according to claim 1; (c) positioning the syringe in the upper section of said reconstitution device and positioning the sealed vial containing the medicament in the lower section of said reconstitution device so that the hollow slotted spike of the device pierces the seal on the vial and enters the interior of the vial; (d) expelling the fluid in the syringe through the hollow slotted spike and into the vial so as to reconstitute the medicament in the vial. 29. A method according to claim 28 further comprising the step of withdrawing the reconstituted fluid from the vial back into the syringe. 30. A method according to claim 28 wherein the medicament is a lyophilized or powdered medicament. 31. A method according to claim 28 wherein the medicament comprises a blood factor concentrate. 32. A method according to claim 28 wherein the medicament comprises factor VIII. 33. A method according to claim 28 wherein the sterile fluid comprises a fluid selected from the group consisting of sterile water, saline solution, half-normal saline, dextrose and other diluents.

Details for Patent 6,358,236

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		2039-09-23