Pharmaceutical component-mixing delivery assembly

• US 5,281,198 A
• Filed: 05/04/1992
• Issued: 01/25/1994
• Est. Priority Date: 05/04/1992
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Smedley, William H., Haber, Terry M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/878,384
• Time in Patent Office: 631 Days
• Field of Search: 604/82, 604/85-91, 604/191, 604/200-205, 604/207-209, 604/232, 604/234
• US Class Current: 604/86
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2027 having frangible parts
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31538 Permanent blocking, e.g. by medical personnel
• CPC Class Codes: A61M 5/31555 by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31595 Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking

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.

Claims

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.

2. The delivery assembly of claim 1 wherein the first pharmaceutical is a diluent and the second pharmaceutical is a lyophilized pharmaceutical component.

3. 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, 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.

4. The delivery assembly of claim 3 wherein the driving means includes:

spike means for fluidly coupling the first and second variable volume regions; and

means for forcing the piston of the first cartridge towards the needle end of the first cartridge by forcing the needle end of the second cartridge into the first cartridge and towards the needle end of the first cartridge.

5. 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;

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.

6. The delivery assembly of claim 5 wherein the reciprocating forcing means includes means for preventing a user from changing said chosen position.

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:

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.

8. The syringe assembly of claim 7 wherein the distal end of the second cartridge passes into the first cartridge through the proximal end of the first cartridge when the cartridges are moved to the second, post-mixed position.

9. The syringe assembly of claim 7 wherein the driving means includes a spike assembly including a double-ended needle adapted to pierce the distal end of the second cartridge and the piston of the first cartridge so to fluidly couple the variable volume regions of the first and second cartridges.

10. The syringe assembly of claim 9 wherein the driving means includes an activation sleeve slidably mounted within the syringe barrel, the second cartridge housed within the activation sleeve for movement therewith.

11. The syringe assembly of claim 10 further comprising means, associated with the syringe barrel, for preventing the unintended movement of the cartridges from the first, pre-mixed position to the second, post-mixed position.

12. The syringe assembly of claim 11 wherein the movement preventing means includes a slot formed in the activation sleeve.

13. The syringe assembly of claim 10 wherein the ratchet plunger is reciprocally mounted within the activation sleeve.

14. The syringe assembly of claim 13 wherein the ratchet plunger includes a bayonet slot means for selectively coupling the ratchet plunger to the second ratchet means.

15. The syringe assembly of claim 13 wherein the ratchet plunger has a length, the ratchet plunger including a dosing key stop positioned at a chosen position along the length, the chosen position determining said distance.

16. The syringe assembly of claim 15 wherein the activation sleeve includes means for preventing access to the dosing key after the ratchet plunger has been mounted within the activation sleeve so to prevent changing the chosen position by the user.

17. The syringe assembly of claim 7 wherein the first cartridge is fixed to the distal end of the syringe barrel.

18. The syringe assembly of claim 7 wherein the first ratchet means is secured to a position adjacent the proximal end of the second cartridge.

19. A method for packaging, dose setting, mixing, and administering repeated equal doses of a multi-component pharmaceutical comprising the following steps:

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.