Reusable pharmaceutical dispenser with full stroke indicator

• US 5,271,527 A
• Filed: 08/18/1992
• Issued: 12/21/1993
• Est. Priority Date: 04/02/1992
• 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): Shaver, Kevin P.
• Application Number:
  US07/931,777
• Time in Patent Office: 490 Days
• Field of Search: 222/25, 222/26, 222/28, 222/39, 222/41, 222/43, 222/46, 222/47, 222/48, 222/49, 222/23, 222/14, 222/52, 222/135, 222/137, 222/145, 222/309, 222/390, 222/391, 222/386, 604/82, 604/186, 604/191
• US Class Current: 222/43
• CPC Class Codes: A61M 2005/2411 from the front
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31543 piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/502 for blocking the piston
• CPC Class Codes: B01L 3/0234 Repeating pipettes, i.e. for dispensing multiple doses from a single charge
• CPC Class Codes: B65D 81/325 Containers having parallel or coaxial compartments, provided with a piston or a movable bottom for discharging contents
• CPC Class Codes: G01F 11/025 : with manually operated pistons G01F19/005 takes precedence
• CPC Class Codes: G01F 11/027 : of the syringe type
• CPC Class Codes: Y02W 30/80 : Packaging reuse or recycling, e.g. of multilayer packaging bio-packaging Y02W90/10

Abstract

A pharmaceutical dispenser includes a housing (4), containing two pharmaceutical cartridges (32,34), slidably mounted to a sliding body (100). A replaceable needle manifold assembly (10) is mounted to the housing and fluidly couples the cartridges with a hypodermic needle at a common exit. The sliding body is part of a reciprocating drive assembly used to drive a pair of drive stems (88) against the pistons (96, 98) of the cartridges, thus forcing predetermined amounts of the pharmaceuticals out the needle. The movement of the sliding body between retracted and post-injection positions remains constant. However, the amounts and proportions of the pharmaceuticals injected during the delivery stroke is chosen by the user using stroke adjusters (182) carried by the sliding body. A bistable status flag (186) is mounted to the sliding body to indicate when the sliding body is in the post-injection and the retracted positions. The dosage adjustments are made when the sliding body is in the post-injection position. If a dose selected is more than is available, the sliding body is prevented from moving to the retracted position so that the status flag is not tripped.

Claims

1. A fluid dispenser comprising:

a housing;

at least first and second variable volume containers mounted to the housing and including first and second exits and first and second movable elements by which the contents of the first and second containers can be forced through said first and second exits as the first and second movable elements are moved within said first and second containers respectively;

a common exit fluidly coupled to the first and second exits;

first and second drive stems drivingly coupled to the first and second movable elements, the first and second drive stems including axially extending drive surfaces; and

a drive assembly, movable from a retracted position to a post-injection position for driving the first and second drive stems so to drive the first and second movable elements within said first and second containers in a cyclic manner, the drive assembly including;

first and second drivers, including one-way drive elements, drivingly coupled to the first and second drive stems along the drive surfaces by the one-way drive elements; and

first and second stroke adjusters for adjusting the relative distances the first and second drivers and the first and second drive stems associated therewith travel during each cycle of the driver so the amounts and proportions of the contents of the first and second containers forced through the first and second exists during each of one or more cycles of the drive assembly can be selected by the user while said amounts and proportions remain the same unless said relative distances are changed.

2. The dispenser of claim 1 further comprising means for indicating when the drive assembly is moved to the post-injection position.

3. The dispenser of claim 2 wherein the indicating means further comprises an indicator and means for actuating said indicator no earlier than during about the last 3% of the movement of the reciprocating drive assembly to the post-injection position.

4. The dispenser of claim 2 wherein the indicating means includes a visual indicator biased towards first and second stable positions corresponding to the post-injection and retracted positions respectively.

5. The dispenser of claim 2, wherein the indicating means includes an audible indication.

6. The dispenser of claim 4 wherein said visual indicator is spring-biased and is pivotally mounted to one of the housing and the drive assembly.

7. The dispenser of claim 6, wherein the visual indictor has a pivot point and is biased by an S-shaped spring positioned adjacent the pivot point.

8. The dispenser of claim 7, wherein the visual indicator is pivotally mounted to the drive assembly and the indicating means includes a pair of spring engaging elements carried by the housing and positioned to engage and deflect the S-shaped spring when the drive assembly is moved to the post-injection and the retracted positions.

9. The dispenser of claim 6, wherein the housing includes a status window, the visual indicator being visible through the status window when the drive assembly is in one of the post-injection and retracted positions, the visual indicator being not visible through the status window when the drive assembly reaches the other of the post-injection and retracted positions.

10. The dispenser of claim 1, further comprising latch means for automatically securing the drive assembly in the post-injection position until a user releases said latch means to help prevent inadvertent movement of the drive assembly from the post-injection position.

11. The dispenser of claim 1, further comprising means for selectively separating at least a portion of the housing and the variable volume containers therewith from the remainder of the dispenser to permit the user to change the variable volume containers.

12. The dispenser of claim 1, further comprising a manifold means, mounted to the housing, for fluidly coupling the first and second exits to a said common exit.

13. The dispenser of claim 12, wherein the manifold means includes means for selectively separating the manifold means from the housing so to permit the manifold means and the variable volume containers to be replaced by the user.

14. The dispenser of claim 1, wherein the variable volume containers include cartridges of the type including a needle-pierceable septum at one end, a movable piston and a pharmaceutical between the septum and the piston.

15. The dispenser of claim 1 wherein the drive surfaces of the drive stems are at least partially defined by axially extending slots formed in the drive stems.

16. The dispenser of claim 1 wherein the one-way drive elements include spring arms positioned at an acute angle to the drive surfaces, the spring arms engaging the drive surfaces.

17. The dispenser of claim 16 further comprising means for selectively releasing the one-way drive elements from the first and second drive stems, the selectively releasing means including a releasing fork mounted coaxially within the reciprocating drivers and adapted to selectively engage the spring arms so to deflect said spring arms away from the drive surfaces.

18. The dispenser of claim 17, further comprising means for locking said drive assembly to prevent movement toward said post-injection position when said drive elements are released.

19. The dispenser of claim 1 wherein the first and second stroke adjusters each include means for individually adjusting the amount each of said first and second drive stems moves during each cycle of the reciprocal drive assembly, each individual adjusting means including a dose control element by which a user selects said amounts of the contents of the respective first and second containers forced through the first and second exits.

20. The dispenser of claim 19, wherein each dose control element is an axially telescoping element to permit the user to easily rotatably manipulate one of said dose control elements without substantial interference with the other dose control element.

21. The dispenser of claim 20, wherein the first and second stroke adjusters each includes means for biasing the means for individually adjusting to a plurality of incremental adjustment positions.

22. The dispenser of claim 1 further comprising means for indicating the amounts of the contents of each of the first and second containers which are to be forced through the first and second exits during each of the one or more cycles of the reciprocating drive means.

23. The dispenser of claim 2, including means for transparently covering said indicating means.

24. The dispenser of claim 19 wherein the indicating means includes first and second visual displays.

25. The dispenser of claim 1 wherein the first and second reciprocating drivers includes:

first and second drive couplings mounted to and movable with the first and second stroke adjusters;

first and second one-way drive element housings, to which the one-way drive elements are mounted, axially slidably mounted to the housing;

the first and second drive couplings and the first and second one-way drive elements being drivingly coupled so that reciprocating movement of the first and second one-way drive elements causes movement of the one-way drive elements according to the adjustments of the first and second stroke adjusters.

26. The dispenser of claim 1 further comprising means for preventing the movement of the reciprocating drive assembly to the retracted position when the contents of at least one of the first and second containers available for discharge through the respective first and second exits is less than the amounts selected by the user using said first and second stroke adjusters.

27. The dispenser of claim 26, wherein the movement preventing means includes an axial groove formed along a portion of the length of each of the first and second drive stems.

28. The dispenser of claim 1, further comprising means for sensing when at least one of said drive stems has moved a predetermined amount and for preventing movement of said drive assembly to said retracted position in response to said sensing.

29. The dispenser of claim 28, wherein said predetermined amount is controlled by movement of said stroke adjusters.

30. A fluid dispenser comprising:

a housing;

at least a first variable volume container mounted to the housing and including a first exit and a first movable element by which the contents of the first container can be forced through said first exit as the first movable element is moved within said first variable volume container;

a drive stem drivingly coupled to the first movable element, the drive stem including an axially extending drive surface;

a drive assembly, movable between a post-injection position and a retracted position, for driving the drive stem so as to drive the first movable element within said first variable volume container in at least a first cycle, the drive assembly including;

a driver, including a one-way drive element, drivingly coupled to the drive stem along the drive surfaces by the one-way drive element; and

a stroke adjuster for adjusting the relative distance the driver and stem associated therewith travel during a cycle of the driver.

31. A dispenser, as claimed in claim 30, including an indicator coupled to said housing, movable between a first position, while said drive assembly is in said retracted position, and a second position in response to movement of said drive assembly substantially fully to said post-injection position.

32. A dispenser, as claimed in claim 31, wherein said indicator comprises a status flag pivotally mounted to the drive assembly at a pivot point.

33. A dispenser, as claimed in claim 32, further comprising a spring positioned adjacent the pivot point and oriented to bias the status flag to either of the post-injection and retracted positions.

34. A dispenser, as claimed in claim 33, further comprising a pair of spring engaging elements carried by the housing and positioned to engage and deflect the spring when the drive assembly is moved to the post-injection and the retracted positions.

35. A dispenser, as claimed in claim 32, further comprising a status window associated with the housing, the flag being visible through the status window when the drive assembly is in one of the post-injection and retracted positions, the flag being not visible through the status window when the drive assembly is in the other of the post-injection and retracted positions.

36. The dispenser of claim 30, further comprising a post-injection latch mounted to the housing and engagable with the drive assembly which, in response to moving the drive assembly to the post-injection position, secures the drive assembly in the post-injection position until a user releases said post-injection latch.

37. The dispenser of claim 30 further comprising at least a second variable volume container having a second exit and a common exit fluidly coupled to the first and second exits;

a manifold having at least a portion moveable to a first position to define a fluid path from the first and second exits to a said common exit.

38. The dispenser of claim 37, wherein the manifold includes a latch movable from a first position holding the manifold to the housing to a second position allowing the manifold to separate from the housing.

39. The dispenser of claim 30, further comprising a stop surface formed in said drive stem positioned to engage said drive assembly to prevent movement thereof when said drive assembly has driven said stem a predetermined amount so that the stroke determined by said stroke adjusters exceeds the effective remaining length of said variable volume container.

40. A fluid dispenser comprising:

a housing;

first and second pharmaceutical-containing cartridges mounted within the housing, the cartridges each including a movable piston, an exit end and a fluid between the piston and the exit end;

a common exit fluidly coupling the exit ends of the cartridges; and

a reciprocating drive assembly comprising;

first and second drive stems adapted to engage the pistons of the first and second cartridges to drive the contents of the cartridges through the exit ends and to the common exit;

a sliding body slidably mounted to the housing for movement in delivery and return directions between post-injection and retracted positions said positions defining an injection stroke length;

first and second reciprocating drivers, coupled to the sliding body, including one-way drive elements coupled to the first and second drive stems, the one-way drive elements and the first and second drive stems configured so that the first and second reciprocating drivers move the first and second drive stems only towards the first and second cartridges during the movement of the sliding body; and

means for separately adjusting the distances the first and second reciprocating drivers move the first and second drive stems towards the first and second cartridges during the movement of the sliding body in the delivery direction so the amounts and proportions of the contents of the first and second cartridges forced through the first and second exit ends and to the common exit during each of one or more cycles of the reciprocating drive assembly can be selected by the user while said amounts and proportions remain the same unless said separately adjusting means are changed.

41. A fluid dispenser comprising:

a housing;

first and second pharmaceutical-containing cartridges mounted within the housing, the cartridges each including a movable piston, an exit end and a fluid between the piston and the exit end;

a common exit fluidly coupling the exit ends of the cartridges; and

a reciprocating drive assembly comprising;

first and second drive stems adapted to engage the pistons of the first and second cartridges to drive the contents of the cartridges through the exit ends to common exit;

a sliding body slidably mounted to the housing for movement in delivery and return directions between post-injection and retracted positions, said positions defining an injection stroke length;

first and second reciprocating drivers, coupled to the sliding body, including one-way drive elements coupled to the first and second drive stems, the one-way drive elements and the first and second drive stems configured so that the first and second reciprocating drivers move the first and second drive stems only towards the first and second cartridges during the movement of the sliding body; and

a user-adjustable coupler for coupling said reciprocating drivers in any of a plurality of positions with respect to said sliding body,

said coupler including coupling means for permitting movement of said sliding body a first distance without corresponding movement of said first reciprocating driver and for forcing corresponding movement of said first reciprocating driver when said sliding body is moved beyond said first distance, while said first reciprocating driver is coupled in a first position, and

said coupler including means for permitting movement of said sliding body a second distance, different from said first distance, without corresponding movement of said second reciprocating driver and for forcing corresponding movement of said second reciprocating driver when said sliding body is moved beyond said second distance while said second reciprocating driver is coupled in a second position.

42. A pharmaceutical dispenser comprising:

a housing;

first and second variable volume containers mounted to the housing and including first and second exits and first and second movable elements by which the contents of the first and second containers can be forced through said first and second exits as the first and second movable elements are moved from first and second staring positions towards first and second ending positions;

a manifold having an interior, a common exit fluidly coupled to the interior and the first and second exits, and a resilient wall partially bounding said interior, said interior wall being deflectable to an extended position by an elevated fluid pressure within said interior which tends to expel the fluid through said common exit to reduce the amount of the fluid therein;

first and second drive stems drivingly coupled to the first and second movable elements; and

a reciprocating drive assembly for reciprocatingly drivingly the first and second drive stems so as to drive the first and second movable elements from the first and second starting positions towards the first and second ending positions by amounts which are user-selectable and independent.

43. A pharmaceutical dispenser, as claimed in claim 42, wherein said manifold includes a check valve for preventing fluid flow in a direction into one of said variable volume containers.