Claims for Patent: 6,494,611

Summary for Patent: 6,494,611

Title:	Apparatus for mixing a liquid and dry powdered components
Abstract:	An apparatus for mixing dry and liquid components is used to form a setting paste. A holder is mounted on the apparatus for reciprocating movement with respect to a base of the apparatus. The movement has an amplitude with components in first and second perpendicular directions. A drive system is operatively connected to the holder for imparting said reciprocating movement to said holder at a predetermined number of cycles per minute. A container having a mass of said dry and liquid components therein is mounted in the holder. The mass, amplitude and cycles per minute of reciprocation being chosen to produce an energy input of at least about 3.times.10.sup.-3 Joules per second per 3 cc of mixture.
Inventor(s):	Edwards; Brian (West Milford, NJ), Higham; Paul (Ringwood, NJ), Zitelli; Joseph (River Edge, NJ)
Assignee:	Howmedica Osteonics Corp. (Allendale, NJ)
Application Number:	09/770,982
Patent Claims:	1. An apparatus for mixing dry and liquid components to form a setting paste comprising: a holder mounted on said apparatus, said holder mounted for reciprocating movement, said movement having an amplitude with components in at least a first and second direction; a drive system operatively connected to said holder for imparting said reciprocating movement to said holder at at least 1600 cycles per minute wherein said reciprocating movement occurs in a plane with the at least first and second component directions being perpendicular along said plane, said drive system includes an input shaft rotating a drive plate, said plate having said holder pivotally mounted thereon at a first pivot point offset from an axis of said input shaft to impart an eccentric motion to said holder as said drive plate rotates about said axis, said holder has a first end coupled to said first pivot point and a second end pivotally mounted on said apparatus at a second pivot point in a manner permitting a first amplitude of movement in said first direction and permitting a lower amplitude of movement in said second direction, said apparatus includes a body having said drive plate mounted thereon with said input shaft rotating said plate about said axis and said first holder end pivot point radially spaced from said axis and said second holder end including a pin slidably mounted on a longitudinal slot in said body, said slot extending in said first direction; and a container mounted in said holder having a mass of dry and liquid components therein, said drive system imparting an energy input of at least about 3.times.10.sup.-3 Joules per second per 3 cc of mixture. 2. The mixing apparatus for mixing as set forth in claim 1 wherein said number of cycles per minute is at least about 1600 and said reciprocating motion is continued for at least 30 seconds. 3. The mixing apparatus as set forth in claim 1 wherein said first holder includes a means for removably mounting said container in said first holder. 4. The mixing apparatus as set forth in claim 1 wherein said container is a syringe containing said dry component and liquid component. 5. The mixing apparatus as set forth in claim 1 wherein said dry component comprises a calcium phosphate mineral powder and said liquid component is an aqueous solution. 6. The mixing apparatus as set forth in claim 5 wherein said calcium phosphate mineral comprises tetra-calcium phosphate and di-calcium phosphate. 7. The mixing apparatus as set forth in claim 6 wherein the aqueous solution contains sodium phosphate. 8. The mixing apparatus as set forth in claim 5 wherein the ratio of liquid to dry powder is between about 0.25 and about 0.30. 9. An apparatus for mixing dry particles of a calcium phosphate mineral powder and an aqueous solution comprising: a calcium phosphate mineral powder and an aqueous solution; a body having a reciprocating drive system mounted thereon, said drive system includes an input shaft rotating a drive plate, said drive plate having a holder pivotally mounted thereon at a pivot point offset from an axis of said input shaft to impart an eccentric motion to said holder as said drive plate rotates about said axis, said holder having a first end coupled to said pivot point and a second end mounted on said apparatus in a manner permitting a first amplitude of movement in said first direction and permitting a lower amplitude of movement in said second direction; a container containing the calcium phosphate mineral powder and the aqueous solution, the container mounted in said holder on said reciprocating drive system, said drive system imparting back and forth movement to said container in at least two directions, said movement at a speed of at least 1600 cycles per minute for a sufficient time to impart an energy input of at least about 3.times.10.sup.-3 Joules per second per 3 cc of mixture and to completely coat the particles of said calcium phosphate mineral with the aqueous solution. 10. The mixing apparatus as set forth in claim 9 where the ratio of aqueous solution to powder is about 0.25 to about 30. 11. The mixing apparatus as set forth in claim 9 wherein the number of cycles of back and forth motion is at least about 1600 per minute and the time is at least 30 seconds. 12. The mixing apparatus as set forth in claim 9 wherein the powdered calcium phosphate material is tetra-calcium phosphate and di-calcium phosphate. 13. The mixing apparatus as set forth in claim 9 wherein the dry calcium phosphate material includes dry sodium phosphate particles. 14. The mixing apparatus as set forth in claim 9 wherein said apparatus includes a body having said drive plate mounted thereon with said input shaft rotating said plate about said axis and said holder first end pivot point radially spaced from said axis and said holder second end including a pin slidably mounted on a longitudinal slot in said body, said slot extending in said first direction. 15. The mixing apparatus as set forth in claim 9 wherein the amplitude in said first direction is about 3.2 cm. 16. A method for mixing dry calcium phosphate minerals with an aqueous solution comprising: placing the dry calcium phosphate minerals and the aqueous solution in a container; mixing the dry calcium phosphate minerals and the aqueous solution by agitating the material in the container at a speed of at least 1600 cycles per second for at least about thirty seconds; said mixing inputting at least about 3.times.10.sup.-3 Joules of energy per second per 3 cc of mixture are inputted into the mixture during agitation placing 3 cc of the mixture in a syringe having an 18 gauge needle; and expelling the mixture from the syringe through said needle with the test being successful of at least about 90% of the mixture is expelled from said syringe within one minute after the completion of mixing. 17. The method for mixing as set forth in claim 16 wherein the dry calcium phosphate is tetra-calcium phosphate and di-calcium phosphate powder. 18. The method for mixing as set forth in claim 17 wherein the liquid is chosen from the group of a sodium phosphate solution, sterile water, deionized water and a combination thereof. 19. The method for mixing as set forth in claim 16 wherein the container is a syringe. 20. A method for mixing a calcium phosphate bone cement comprising: placing dry calcium phosphate mineral material and an aqueous solution in a liquid to dry material ratio of 0.25 to 0.30 in a container; and mixing the dry calcium phosphate minerals and the aqueous solution by agitating the container at a speed of at least 1600 cycles per minute to input at least about 3.times.10.sup.-3 Joules of energy per second per 3 cc of mixture. 21. An apparatus for mixing dry particles of a calcium phosphate mineral powder and an aqueous solution comprising: a calcium phosphate mineral powder and an aqueous solution; a body having a reciprocating drive system mounted thereon; and a container containing the calcium phosphate mineral powder and the aqueous solution, the container mounted in a holder on said reciprocating drive system, said drive system imparting back and forth movement to said container in at least two directions, said movement being at least 1600 cycles per minute and at a sufficient amplitude for a sufficient time to completely coat the particles of said calcium phosphate mineral with the aqueous solution by inputting at least about 3.times.10.sup.-3 Joules of energy per 3 cc of mixture. 22. The mixing apparatus as set forth in claim 21, wherein the ratio of aqueous solution to powder is about 0.25 to about 0.30. 23. The mixing apparatus as set forth in claim 21, wherein the time is at least 30 seconds. 24. The mixing apparatus as set forth in claim 21, wherein the powdered calcium phosphate material is tetra-calcium phosphate and di-calcium phosphate. 25. The mixing apparatus as set forth in claim 21, wherein said drive system includes an input shaft rotating a drive plate, said drive plate having said holder pivotally mounted thereon at a pivot point offset from an axis of said input shaft to impart an eccentric motion to said holder as said drive plate rotates about said axis, said holder having a first end coupled to said pivot point and a second end mounted on said apparatus in a manner permitting a first amplitude of movement in said first direction and permitting a lower amplitude of movement of said second direction. 26. The mixing apparatus as set forth in claim 25, wherein said apparatus includes a body having said drive plate mounted thereon with said input shaft rotating said plate about said axis and said first holder end pivot point radially spaced from said axis and said second holder end including a pin slidably mounted on a longitudinal slot in said body, said slot extending in said first direction. 27. The mixing apparatus as set forth in claim 26, wherein the amplitude in said first direction is about 3.2 cm. 28. The method of mixing as set forth in claim 21, further comprising testing the mixture by placing 3 cc of the mixture in a syringe having an 18 gauge needle and expelling the mixture from the syringe through said needle with the test being successful if at least about 90% of the mixture is expelled from said syringe within one minute after the completion of mixing.

Details for Patent 6,494,611

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