Method and apparatus for sequential delivery of multiple injectable substances stored in a prefilled syringe

• US 6,866,653 B2
• Filed: 10/31/2002
• Issued: 03/15/2005
• Est. Priority Date: 10/31/2002
• Status: Active Grant

• Current Assignee: Kyongtae T. Bae
• Original Assignee: Kyongtae T. Bae
• Inventors: Bae, Kyongtae T.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/285,001
• Publication Number:
  US 20040097875A1
• Time in Patent Office: 866 Days
• Field of Search: 604/82, 604/89, 604/90, 604/91, 604/191, 604/200, 604/205
• US Class Current: 604/191
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence

Abstract

A syringe, which may be pre-filled, and a method of using the syringe is disclosed to provide sequential injection of two different fluids without mixing thereof. The syringe comprises in a first version a plunger and an intermediate disc sealingly disposed within a generally cylindrical barrel, with an outlet portion distal of the barrel, the outlet portion being generally larger in diameter so that as the disc is advanced into it far enough to substantially inject the first fluid the disc loses sealing engagement and the second fluid is then expelled around the disc and through the syringe opening. Baffles are provided within the outlet portion to prevent the disc from inadvertently sealing the opening, and channels may be provided around the baffles. In a second version a bag is provided adjacent the plunger, with the first fluid being contained within the barrel and the second fluid being contained within the bag, and at least one barb is provided in the bottom of the syringe to burst the bag after the first fluid is expelled to thereby expel the second fluid.

Claims

1. A sequential injection syringe comprising a generally cylindrical barrel portion, a plunger and an intermediate disc being disposed in a spaced apart relationship within said barrel portion, each of said plunger and disc being sized to be in sealing engagement with said barrel portion, an outlet portion disposed generally at a distal end of said syringe, said outlet portion having an outlet opening through which fluids contained within said syringe are expelled, a first chamber for containing a first fluid within said syringe formed between the outlet portion and the disc, and a second chamber for containing a second fluid within said syringe formed between the disc and the plunger, said outlet portion having a radially enlarged portion with a protrusion in the radially enlarged portion that extends into an interior of the syringe, said protrusion being adapted to engage the intermediate disc in the radially enlarged portion as the disc is advanced to the syringe outlet opening, said radially enlarged portion being dimensioned to permit tilting of the disc in the syringe interior as the protrusion engages the disc and the disc loses sealing engagement with said syringe to thereby allow the second fluid to flow through the outlet opening after the first fluid has been substantially expelled therethrough.

2. The sequential injection syringe of claim 1 wherein said radially enlarged portion has a central axis offset from a central axis of said barrel portion.

3. The sequential injection syringe of claim 1 wherein said radially enlarged portion is dimensioned to permit partial rotation of the disc in the syringe interior as the protrusion engages the disc and the disc loses sealing engagement with said syringe.

4. The sequential injection syringe of claim 1 wherein said radially enlarged portion is formed within a wall thickness of the cylindrical barrel portion of the syringe.

5. A pre-filled, sequential injection syringe comprising a generally cylindrical barrel portion, a plunger and an intermediate disc being disposed in a spaced apart relationship within said barrel portion, each of said plunger and disc being sized to be in sealing engagement with said barrel portion, an outlet portion disposed generally at a distal end of said syringe, said outlet portion having an outlet opening through which fluids contained within said syringe are expelled, a first fluid contained within said syringe and between the outlet portion and the disc, and a second fluid contained within said syringe and between the disc and the plunger, said outlet portion having a radially enlarged portion with a protrusion in the radially enlarged portion that extends into an interior of the syringe, said protrusion being adapted to engage the intermediate disc in the radially enlarged portion as the disc is advanced to the syringe opening, said radially enlarged portion being dimensioned to permit tilting of the disc in the syringe interior as the protrusion engages the disc and the disc loses sealing engagement with said syringe to thereby allow the second fluid to flow through the outlet opening after the first fluid has been substantially excelled therethrough.

6. The pre-filled, sequential injection syringe of claim 5 wherein said radially enlarged portion has a central axis offset from a central axis of said barrel portion.

7. The pre-filled, sequential injection syringe of claim 5 wherein said radially enlarged portion is dimensioned to permit partial rotation of the disc in the syringe interior as the protrusion engages the disc and the disc loses sealing engagement with said syringe.

8. The pre-filled, sequential injection syringe of claim 5 wherein said radially enlarged portion is formed within a wall thickness of the cylindrical barrel portion of the syringe.

9. A method for sequentially expelling two fluids from a single syringe without mixing of the fluids comprising the steps of:

providing the syringe with a first fluid between a syringe opening and an intermediate disc and a second fluid between the intermediate disc and a plunger, each of the disc and plunger being in sealing engagement with the syringe, said syringe having an outlet portion being disposed generally at a distal end of said syringe, said outlet portion having a radially enlarged portion with a protrusion in the radially enlarged portion that extends into an interior the syringe;

advancing the plunger and disc within the syringe to expel the first fluid;

advancing the plunger and disc within the syringe so as to engage the disc against the protrusion thereby dis-engaging the disc from its sealing engagement with the syringe and creating a channel around the disc from the syringe interior to the syringe opening; and

continuing to advance the plunger to thereby expel the second fluid from the syringe interior around the disc through the channel and out the syringe opening.