Non-reusable drug prefilled syringe assembly and method of use
First Claim
1. In a syringe, adapted to preclude reuse, prefilled with a drug solution, having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, the syringe having an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel, the improvement which comprisesa plunger assembly including a plunger-rod having a projection at one end, the projection comprising a reduced diameter portion terminating in a flanged tip, and the elastomeric stopper having a recess in one end thereof, the recess terminating in an enlarged flange receiving portion, wherein the diameter of the flanged tip of the projection of the rod is less than the diameter of the flange receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, the interengaging surfaces of which are configured for releasably making engagement, anda drug solution contained within the syringe,wherein the plunger assembly is adapted so that the stopper is not released from the projection of the rod when limited manual withdrawal of the plunger is performed when the syringe is filled with the solution, for a vein test prior to administration of the solution of the drug to be administered, andthe stopper is disconnected from the rod, remaining in the barrel, when, after the drug has been administered, and the syringe is empty, the plunger is withdrawn within the barrel with a force equal to that necessary to aspirate a new drug solution into the syringe,thereby rendering the syringe useless for reuse.
0 Assignments
0 Petitions
Accused Products
Abstract
A non-reusable prefilled syringe for a single administration of a drug solution. The syringe has a plunger for expelling the solution which is detachably fitted with an elastomeric cap. The syringe allows for a pre-vein test but is not adapted for reuse. A method of use for subcutaneous injection of mini-doses of the drug solution.
-
Citations
37 Claims
-
1. In a syringe, adapted to preclude reuse, prefilled with a drug solution, having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, the syringe having an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel, the improvement which comprises
a plunger assembly including a plunger-rod having a projection at one end, the projection comprising a reduced diameter portion terminating in a flanged tip, and the elastomeric stopper having a recess in one end thereof, the recess terminating in an enlarged flange receiving portion, wherein the diameter of the flanged tip of the projection of the rod is less than the diameter of the flange receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, the interengaging surfaces of which are configured for releasably making engagement, and a drug solution contained within the syringe, wherein the plunger assembly is adapted so that the stopper is not released from the projection of the rod when limited manual withdrawal of the plunger is performed when the syringe is filled with the solution, for a vein test prior to administration of the solution of the drug to be administered, and the stopper is disconnected from the rod, remaining in the barrel, when, after the drug has been administered, and the syringe is empty, the plunger is withdrawn within the barrel with a force equal to that necessary to aspirate a new drug solution into the syringe, thereby rendering the syringe useless for reuse.
-
6. In a syringe, adapted to preclude reuse, pre-filled with a drug solution, having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, the syringe having an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel, the improvement which comprises
a plunger assembly including a plunger-rod having a projection at one end, the projection comprising a reduced diameter portion terminating in a flanged tip, and the elastomeric stopper having a recess in one end thereof, the recess terminating in an enlarged flange receiving portion, wherein the diameter of the flanged tip of the projection of the rod is less than the diameter of the flange receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, the interengaging surfaces of which are configured for releasably making engagement, so that the stopper is not released from the projection of the rod when limited manual withdrawal of the plunger is performed for a vein test prior to administration of the solution of the drug to be administered, and the stopper is disconnected from the rod, remaining in the barrel, when, after the drug has been administered, the plunger is withdrawn within the barrel with a force equal to that necessary to aspirate a new solution into the syringe, thereby rendering the syringe useless for reuse.
-
26. In a syringe, adapted to preclude reuse, prefilled with a heparin salt solution, having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, the syringe having an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel,
the improvement which comprises a plunger assembly including a plunger-rod having a projection at one end, the projection comprising a reduced diameter portion terminating in a frustoconical tip, and the elastomeric stopper, which is a solid, unitary structure, having a recess in one end thereof, the recess extending into an enlarged tip receiving portion, the terminating end of which is conical, wherein the diameter of the frustoconical tip of the projection of the rod is less than the diameter of the tip receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, wherein the frustoconical tip of the projection of the plunger-rod and the conical portion of the surface of the recess of the stopper are configured so that the truncated portion of the frustoconical tip does not contact the apex of the conical surface portion of the recess, and so that the oblique portions of the frustoconical tip do contact the conical surface portion of the recess, wherein the stopper has ribs which cooperate with the sides of the barrel of the syringe to seal the drug solution in the barrel, the ribs being separated by areas which are annularly spaced away from the barrel of the syringe, the surfaces of the annular separations along the stopper being non-linear, and the end of the stopper which contacts the plunger-rod being annularly separated from the barrel of the syringe, and wherein the interengaging surfaces of the stopper and the projection of the plunger-rod are configured so that, the stopper is not released from the projection of the rod when limited manual withdrawal of the plunger is performed for a vein test prior to administration of the solution of the drug to be administered, and
- 27. the stopper is disconnected from the rod, remaining in the barrel, when, after the drug has been administered, the plunger is withdrawn within the barrel with a force equal to that necessary to aspirate a new solution into the syringe, thereby rendering the syringe useless for reuse.
-
31. In a syringe, adapted to preclude reuse, prefilled with a drug solution, having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, the syringe having an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel,
the improvement which comprises a plunger assembly including a plunger-rod having a projection at one end, and the elastomeric stopper having a recess in one end thereof, and means for releasably engaging the stopper and the projection of the plunger-rod, so that the stopper is not released from the projection of the rod when there is performed a vein test prior to administration of the solution of the drug to be administered, and so that the stopper must disconnect from the rod, remaining in the barrel, whenever, after the drug has been administered, the plunger is withdrawn within the barrel to aspirate a new solution into the syringe, thereby rendering the syringe useless for reuse, wherein the engaging means comprises the projection of the plunger-rod and the recess of the stopper wherein the projection of the plunger-rod has a reduced diameter portion which terminates in a frustoconical tip, the recess of the stopper, which stopper is solid and unitary, extends into an enlarged tip receiving portion, the terminating end of which is conical, and wherein the diameter of the frustoconical tip of the projection of the rod is less than the diameter of the tip receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, and wherein the frustoconical tip of the projection of the plunger-rod and the conical portion of the surface of the recess of the stopper are configured so that the truncated portion of the frustoconical tip does not contact the apex of the conical surface portion of the recess, and so that the oblique portions of the frustoconical tip do contact the conical surface portion of the recess.
-
32. A method for administering once a preselected mini-dose of a solution of heparin salt with a syringe, adapted to preclude reuse, the syringe having a hollow syringe barrel with an open distal end adapted to have a needle fixed thereto in fluid communication therewith for dispensing of the drug solution contained therein through the needle, an open rear end adapted to be sealed by an elastomeric stopper in sliding engagement with the walls of the syringe barrel, and a plunger assembly including a plunger-rod having a projection at one end, the projection comprising a reduced diameter portion terminating in a flanged tip, and the elastomeric stopper having a recess in one end thereof, the recess terminating in an enlarged flange receiving portion, wherein the diameter of the flanged tip of the projection of the rod is less than the diameter of the flange receiving portion of the recess of the stopper but greater than the diameter of the recess of the stopper, the interengaging surfaces of which are configured for releasably making engagement, so that the stopper is not released from the projection of the rod when limited manual withdrawal of the plunger is performed when the syringe is filled with the solution, for a vein test prior to administration of the solution of the drug to be administered, and the stopper is disconnected from the rod, remaining in the barrel, when the plunger is withdrawn within the barrel when the syringe is empty, after the drug has been administered, in an attempt to aspirate a new solution into the syringe, which method comprises:
-
administering the solution contained in the full syringe subcutaneously to the patient, and thereafter attempting to withdraw the plunger assembly within the barrel for aspiration of a new solution into the empty syringe, while simultaneously, disconnecting the stopper from the projection of the plunger-rod, whereby the stopper is disconnected from the plunger-rod rendering the syringe useless for reuse. - View Dependent Claims (34)
-
Specification