Pharmaceutical component-mixing delivery assembly
First Claim
1. A pharmaceutical component-mixing delivery assembly comprising:
- first and second cartridges including needle ends, plunger ends, interiors and pistons within the interiors, the first and second cartridges containing first and second pharmaceutical components within first and second variable volume regions defined between the needle ends and the pistons;
means for housing the first and second cartridges, the first and second cartridges being movable relative to one another from a pre-mixed position to a post-mixed position;
means for driving the first pharmaceutical component from the first variable volume region into the second variable volume region to create a mixed pharmaceutical when the cartridges are moved to the post-mixed position;
means for accessing the mixed pharmaceutical; and
reciprocating means for forcing first and second predetermined amounts of the mixed pharmaceutical through the accessing means by driving the piston of the second cartridge a distance during first and second strokes of the reciprocating means, the first and second predetermined amounts having approximately the same volume.
1 Assignment
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Accused Products
Abstract
A pharmaceutical component-mixing syringe assembly (2) is particularly suited for packaging, reconstituting and dispensing a series of equal doses of a multiple component pharmaceutical, such as human growth hormone reconstituted from a diluent component (128) and a lyophilized component (34). The pharmaceutical components are contained within first and second cartridges (10, 36) of the type having a movable piston (12, 40). The second cartridge is forced into the interior of the first cartridge causing a spike assembly (132) between the two to fluidly couple the two cartridges and drive the piston of the first cartridge into the first cartridge causing the contents of the first cartridge to be driven into the second cartridge, thereby mixing. A reciprocating ratchet plunger (104) is used to drive the second piston. The distance the ratchet plunger moves, and thus the dose, is determined by the position of a user-inaccessible dosing key stop (116) along the length of the ratchet plunger.
405 Citations
19 Claims
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1. A pharmaceutical component-mixing delivery assembly comprising:
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first and second cartridges including needle ends, plunger ends, interiors and pistons within the interiors, the first and second cartridges containing first and second pharmaceutical components within first and second variable volume regions defined between the needle ends and the pistons; means for housing the first and second cartridges, the first and second cartridges being movable relative to one another from a pre-mixed position to a post-mixed position; means for driving the first pharmaceutical component from the first variable volume region into the second variable volume region to create a mixed pharmaceutical when the cartridges are moved to the post-mixed position; means for accessing the mixed pharmaceutical; and reciprocating means for forcing first and second predetermined amounts of the mixed pharmaceutical through the accessing means by driving the piston of the second cartridge a distance during first and second strokes of the reciprocating means, the first and second predetermined amounts having approximately the same volume. - View Dependent Claims (2)
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3. A pharmaceutical component-mixing delivery assembly comprising:
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first and second cartridges including needle ends, plunger ends, interiors and pistons within the interiors, the first and second cartridges containing first and second pharmaceutical components within first and second variable volume regions defined between the needle ends and the pistons, the first and second cartridges being sized so that the needle end of the second cartridge can pass into the first cartridge through the plunger end of the first cartridge; housing means for housing the first and second cartridges, the first and second cartridges being movable relative to one another from a pre-mixed position to a post-mixed position; means for driving the first pharmaceutical component from the first variable volume region into the second variable volume region to create a mixed pharmaceutical when the cartridges are moved to the post-mixed position; means for accessing the mixed pharmaceutical; and reciprocating means for forcing first and second predetermined amounts of the mixed pharmaceutical through the accessing means by driving the piston of the second cartridge a distance during first and second strokes of the reciprocating means, the first and second predetermined amounts having approximately the same volume. - View Dependent Claims (4)
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5. A pharmaceutical component-mixing delivery assembly comprising:
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first and second cartridges including needle ends, plunger ends, interiors and pistons within the interiors, the first and second cartridges containing first and second pharmaceutical components within first and second variable volume regions defined between the needle ends and the pistons; housing means for housing the first and second cartridges, the first and second cartridges being movable relative to one another from a pre-mixed position to a post-mixed position; means for driving the first pharmaceutical component from the first variable volume region into the second variable volume region to create a mixed pharmaceutical when the cartridges are moved to the post-mixed position; means for accessing the mixed pharmaceutical; and reciprocating means for forcing first and second predetermined amounts of the mixed pharmaceutical through the accessing means by driving the piston of the second cartridge a distance during first and second strokes of the reciprocating means, the first and second predetermined amounts having approximately the same volume, the reciprocating forcing means also including a reciprocating ratchet plunger having a length, and a dosing key stop mounted to the plunger at a chosen position along the length, the chosen position corresponding to said distance the piston of the second cartridge moves during each stroke. - View Dependent Claims (6)
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7. A pharmaceutical component-mixing syringe assembly, comprising with first and second cartridges of the type having a cartridge barrel with an interior, an open proximal end, a normally sealed distal end and a piston within the interior, the pistons defining variable volume regions within the first and second cartridges within which first and second pharmaceutical components are contained, and further comprising:
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a syringe barrel having an interior, open proximal and distal ends, the first and second cartridges at least partially housed within the interior thereof with the distal end of the second cartridge facing the proximal end of the first cartridge, the first and second cartridges being movable relative to one another from a first, pre-mixed position to a second, post-mixed position when the first and second cartridges are in the at least partially housed position within the interior; means for driving the first pharmaceutical component from the variable volume region of the first cartridge into the variable volume region of the second cartridge to mix with the second pharmaceutical component therein to create a mixed pharmaceutical when the cartridges are in the second, post-mix position; a dispensing element in fluid communication with the mixed pharmaceutical when the cartridges are in the second, post-mix position; a drive stem mounted within the syringe barrel for movement therein; first ratchet means for preventing the drive stem from moving in a proximal direction, that is in the direction from the distal end to the proximal end of the syringe barrel when the cartridges are in the second, post-mix position; a reciprocating ratchet plunger; second ratchet means, engaging the drive stem and connected to the ratchet plunger, for driving the drive stem in a distal direction, that is in the direction from the proximal end to the distal end of the syringe barrel, upon movement of the ratchet plunger in the distal direction and when the cartridges are in the second, post-mix position; and the ratchet plunger being movable a distance between a pre-injection position, away from the second cartridge, and a post-injection position, towards the second cartridge; whereby repeated reciprocal movements of the ratchet plunger between the pre-injection and post-injection positions causes the drive stem to drive the piston of the second cartridge the distance in the distal direction to drive amounts of the mixed pharmaceutical through the dispensing element. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for packaging, dose setting, mixing, and administering repeated equal doses of a multi-component pharmaceutical comprising the following steps:
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selecting first and second cartridges, having hollow interiors, needle ends, plunger ends and pistons therebetween, the first and second cartridges containing first and second pharmaceutical within the hollow interiors between the needle ends and the pistons thereof; mounting the first and second cartridges at least partly within a housing in an axially aligned orientation with the plunger end of the first cartridge opposite the needle end of the second cartridge; positioning a dose-setting key stop at a chosen position along a user operated ratchet plunger, said chosen position corresponding to said equal doses; securing the ratchet plunger to the housing with the dose-setting key stop at a user-inaccessible location thereby preventing the user from changing the position of the dose-setting key stop along the ratchet plunger; forcing the first pharmaceutical from the first cartridge to the second cartridge thereby creating a mixed pharmaceutical; and actuating the ratchet plunger by; moving the ratchet plunger in a proximal direction away from the cartridges to a preinjection position determined by the chosen position of the dose-setting key stop; and moving the ratchet plunger in a direction towards the cartridges a distance determined by the chosen position of the dose-setting key stop thereby moving the piston of the second cartridge towards the needle end of the second cartridge said distance thereby dispensing one of said equal doses of said mixed pharmaceutical.
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Specification