MEDICATION INJECTOR APPARATUS WITH DRIVE ASSEMBLY THAT FACILITATES RESET

• US 20070123829A1
• Filed: 01/31/2007
• Published: 05/31/2007
• Est. Priority Date: 05/16/2001
• Status: Active Grant

• Current Assignee: Bobby Walter, Donna Taylor, Douglas Boyd, Mark Diller, Peter Gaydos, Shannon Hoste, Steven Madland, William Atterbury
• Original Assignee: Bobby Walter, Donna Taylor, Douglas Boyd, Mark Diller, Peter Gaydos, Shannon Hoste, Steven Madland, William Atterbury
• Inventors: Hoste, Shannon, Atterbury, William, Taylor, Donna, Walter, Bobby, Madland, Steven, Diller, Mark, Boyd, Douglas, Gaydos, Peter
• Granted Patent: US 7,704,238 B2
• Time in Patent Office: Days
• US Class Current: 604/207
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2488 via rotation, e.g. threads or bayonet
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• 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 5/31543 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 5/31556 Accuracy improving means
• CPC Class Codes: A61M 5/31558 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31573 Accuracy improving means
• CPC Class Codes: A61M 5/31575 : using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31585 : performed by axially moving actuator, 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: G01D 5/2497 : Absolute encoders G01D5/2454 takes precedence
• CPC Class Codes: G01D 5/25 : Selecting one or more conductors or channels from a plurality of conductors or channels, e.g. by closing contacts

Abstract

A medication injector apparatus such as an injection pen. The injection pen includes a resettable, cartridge plunger drive assembly including an axially floating nut, a cartridge plunger engaging screw, and a drive clutch movable with the nut and which when rotated causes the screw to screw through the nut. When a cartridge assembly is mounted to the pen base, the floating nut and drive clutch are shifted proximally such that the drive clutch is in torque transmitting engagement with a rotatable drive member of the pen, such that rotation of that drive member results in drive screw advancement through the nut in the distal direction. When the cartridge assembly is not mounted to the pen base, the floating nut and drive clutch are biased distally to disengage the drive clutch from torque transmitting engagement with the rotatable drive member and to thereby allow the drive screw to be reset proximally through the nut to a position more retracted within the pen base. The injection pen also may include an injection clicker assembly having a collar arranged coaxially on a drive sleeve and which oscillates axially on the drive sleeve that rotates during medication dispensing to provide an audible clicking sound that indicates injecting use of the pen. The injection pen also may include a doseable quantity identifier that uses a rotational matrix and a sensor for electrically sensing the arrangement of the dose setting mechanism of the pen, which identifier may be part of a therapeutic dose indicating system that utilizes a cartridge recognizer to recognize a concentration of medication so as to allow an automatic determination of a therapeutic dose. The injection pen further may include an assembly for selectively rotating a drive sleeve of the pen, which assembly has a dial that rotates out during dose setting and which translates in without rotation during dose injecting.

Claims

1. (canceled)

2. (canceled)

3. (canceled)

4. (canceled)

5. (canceled)

6. (canceled)

7. (canceled)

8. (canceled)

9. (canceled)

10. (canceled)

11. An injection clicker assembly of a medication injector apparatus, the apparatus including a drive screw advanceable in a distal direction to shift a movable plunger of a cartridge so as to force medication from an outlet of the cartridge, a drive sleeve of a dose injecting mechanism rotatable in a first direction within a housing of the apparatus, the drive sleeve including a distal facing surface and defining a longitudinal bore in which the drive screw extends, and a clutch, connected to the drive screw, that is rotated by engagement with the drive sleeve distal facing surface to thereby rotate and advance the drive screw through a nut within the housing, the injection clicker assembly comprising:

a collar arranged coaxially on the drive sleeve at a location proximal of the distal facing surface of the drive sleeve, said collar connected to the drive sleeve to be axially movable relative thereto and rotatably fixed thereto when the drive sleeve rotates in the first direction, said collar including a plurality of teeth extending in an axial direction and adapted to engage mating teeth of a stop surface one of integrally formed with and non-rotatably connected to a housing of the apparatus;

a biasing element adapted to force said collar axially into meshing engagement with said stop surface; and

said collar and said stop surface being complementarily configured such that during rotation of the drive sleeve in the first direction, and due to a returning force applied to said collar by said biasing element, said collar oscillates axially on said drive sleeve as said collar teeth slide over said stop surface teeth to provide an audible clicking sound that indicates injecting use of the apparatus.

12. The injection clicker assembly of claim 11 wherein said biasing element comprises a compression spring arranged coaxially on the drive sleeve and having first and second ends, wherein said first end abuts a radially protruding portion of the drive sleeve, and said second end abuts said collar.

13. The injection clicker assembly of claim 12 wherein said first end of said spring abuts a proximal side of the radially protruding portion of the drive sleeve, and wherein the distal facing surface of the drive sleeve is disposed on a distal side of the radially protruding portion of the drive sleeve.

14. The injection clicker assembly of claim 11 wherein said collar teeth extend distally.

15. The injection clicker assembly of claim 11 wherein said collar is keyed to the drive sleeve to be rotatably fixed thereto, and wherein said teeth of said collar and said stop surface are configured for unidirectional rotation, whereby meshing of the teeth of said collar and said stop surface prevent rotation of the drive sleeve in a direction opposite the first direction.

16. The injection clicker assembly of claim 15 further comprising a retaining ring axially fixed to the drive sleeve and radially projecting to limit axial motion in the distal direction of said collar on the drive sleeve.

17. The injection clicker assembly of claim 16 wherein said retaining ring fits within a circumferential groove of the drive sleeve.

18. A therapeutic dose indicating apparatus for a portable medication injector device which includes an adjustable dose setting mechanism, the portable medicine injector device loaded with a replaceable medicine container, comprising:

a visible display;

a container recognizer that recognizes a concentration of medicine within the container, said container recognizer including an identifier disposed on the container;

a doseable quantity identifier that identifies a volume of medicine selected for delivery by the adjustable dose setting mechanism; and

a controller adapted to determine a therapeutic dose based on said recognized concentration and said identified volume and cause the therapeutic dose to be displayed in said visible display.

19. The therapeutic dose indicating apparatus of claim 18 wherein the container comprises a cartridge assembly including a cartridge within an outer housing connectable to a reusable base of the injector device, and wherein said identifier is disposed on said outer housing.

20. The therapeutic dose indicating apparatus of claim 19 wherein said outer housing includes a reduced diameter hub aligned with a length of said cartridge and on which is disposed said identifier, and wherein said hub fits within said reusable base of the injector device.

21. The therapeutic dose indicating apparatus of claim 18 wherein said identifier consists of a single band having a dimensional aspect and a spatial aspect representative of the concentration of medicine.

22. The therapeutic dose indicating apparatus of claim 21 wherein said single band is electrically conductive, wherein said container recognizer comprises a plurality of electrical contacts, and wherein different combinations of said plurality of electrical contacts are circuited together by the single bands of containers filled with different concentrations of medicine.

23. The therapeutic dose indicating apparatus of claim 18 wherein said doseable quantity identifier includes a rotational matrix and a sensor array adapted to identify data included in said matrix, wherein said rotational matrix and said sensor array are respectively mounted on first and second components of said medicine delivery device which rotate relative to each other during adjustment of the dose setting mechanism.

24. The therapeutic dose indicating apparatus of claim 23 wherein said matrix includes a plurality of rows which extend around a circumference of the first component, and a plurality of columns which extend along an axial length of the first component.

25. The therapeutic dose indicating apparatus of claim 24 wherein said plurality of columns comprises twenty-four columns.

26. The therapeutic dose indicating apparatus of claim 24 wherein said sensor array includes a plurality of electrical contacts, each of said contacts aligned with a different row of said matrix, wherein said matrix data is in the form of the presence or absence of an electrically conductive material at intersections of said rows and columns of said matrix, and wherein for different rotational positions of said rotational matrix relative to said sensor array different combinations of said plurality of electrical contacts are circuited together by the matrix data formed by the presence of electrically conductive material.

27. The therapeutic dose indicating apparatus of claim 26 wherein during adjustment of the dose setting mechanism said first component is axially fixed relative to said second component.

28. The therapeutic dose indicating apparatus of claim 26 wherein said sensor array and said rotational matrix are cooperatively configured such that any rotational movement of said sensor array relative to said rotational matrix between adjacent rows at which said matrix data is grounded causes only a single electrical contact to switch its electrical circuitry relationship with said matrix data.

29. The therapeutic dose indicating apparatus of claim 26 wherein all of said electrically conductive material of said matrix data is contiguous.

30. A doseable quantity identifier for a medication injector apparatus having a dose setting mechanism operable to select a volume of medicine to be delivered from a held cartridge, comprising:

a rotational matrix disposed on a first component of the apparatus;

a sensor for electrically sensing the rotational matrix, said sensor disposed on a second component of the apparatus which experiences rotational motion relative to the first component during operation of the dose setting mechanism;

whereby data of said rotational matrix sensible by said matrix sensor is thereby indicative of an arrangement of the dose setting mechanism;

a controller circuited with said sensor which interprets data of said rotational matrix sensed by said sensor to determine a quantity of medicine to be delivered from the cartridge during injection; and

a visible display that displays the quantity of medicine to be delivered as determined by said controller.

31. The doseable quantity identifier of claim 30 wherein said matrix includes a plurality of rows which extend around a circumference of the first component, and a plurality of columns which extend along an axial length of the first component.

32. The doseable quantity identifier of claim 31 wherein said plurality of columns comprises twenty-four columns.

33. The doseable quantity identifier of claim 31 wherein said sensor includes a plurality of electrical contacts, each of said contacts aligned with a different row of said matrix, and wherein said matrix data is in the form of the presence or absence of an electrically conductive material at intersections of said rows and columns of said matrix.

34. The doseable quantity identifier of claim 30 wherein data of said rotational matrix is unique for each settable rotational arrangement of the first component relative to the second component.

35. The doseable quantity identifier of claim 30 wherein said rotational matrix data comprises a gray code coding scheme.

36. The doseable quantity identifier of claim 33 further comprising a redundant electrical contact aligned with the same row of said matrix as one of said plurality of electrical contacts.

37. The doseable quantity identifier of claim 30 wherein said matrix includes a plurality of rows and a plurality of columns, wherein said sensor includes a plurality of electrical contacts, each of said contacts aligned with a different row of said matrix, wherein said matrix data is in the form of the presence or absence of an electrically conductive material at intersections of said rows and columns of said matrix, and wherein said plurality of electrical contacts and said rotational matrix are cooperatively configured such that when the first and second components are relatively rotationally shifted from a first rotational position, a change in matrix data sensed by any single electrical contact does not produce a pattern corresponding to a rotational position that is within a range of rotational positions in either direction away from the first rotational position, said range being inclusively between two and at least three positions.

38. The doseable quantity identifier of claim 37 wherein said at least three positions is six positions.

39. The doseable quantity identifier of claim 30 wherein said matrix includes a plurality of rows and a plurality of columns, wherein said sensor includes a plurality of electrical contacts, each of said contacts aligned with a different row of said matrix, wherein said matrix data is in the form of the presence or absence of an electrically conductive material at intersections of said rows and columns of said matrix, and wherein said plurality of electrical contacts and said rotational matrix are cooperatively configured such that matrix data of each column of said matrix is not unique, and wherein said controller is adapted to identify the correct relative rotational positioning of the first and second components based upon a previous valid positioning thereof and a range of positions adjacent to said previous valid positioning on either side.

40. The doseable quantity identifier of claim 30 wherein said matrix includes a plurality of rows and a plurality of columns, wherein said sensor includes a plurality of electrical contacts, each of said contacts aligned with a different row of said matrix, wherein said matrix data is in the form of the presence or absence of an electrically conductive material at intersections of said rows and columns of said matrix, and wherein said plurality of electrical contacts and said rotational matrix are cooperatively configured such that any relative rotational shifting of the first and second components between adjacent columns at which a logic high or ground input to the matrix data remains constant results in exactly two of said plurality of electrical contacts switching their electrical circuitry relationship with the matrix data.

41. A method of indicating a therapeutic dose to a user of a portable medication injector apparatus loaded with a cartridge of medicine, the medication injector apparatus including a dose setting mechanism operable to select a volume of medicine for delivery, comprising the steps of:

recognizing a concentration of the medicine within the cartridge with a cartridge recognizer of the portable medication injector apparatus;

identifying a selected delivery volume with a doseable quantity identifier of the portable medication injector apparatus;

determining the therapeutic dose with a controller of the portable medication injector apparatus using the recognized concentration and the identified selected delivery volume as input; and

displaying the determined therapeutic dose on a display of the portable medication injector apparatus.

42. The method of claim 41 wherein the cartridge recognizer includes a concentration identifier on the cartridge and an identifier sensor in the medication injector apparatus.

43. The method of claim 41 further comprising the step of providing the medication injector apparatus with a set button manually operable by the user to input a concentration value to the controller in the event the cartridge recognizer fails to recognize the concentration of the medicine within the cartridge, and wherein the controller uses the manually input concentration value with the identified selected delivery volume as input in determining the therapeutic dose.

44. A medication injector apparatus comprising:

a housing;

a fluid container mounted to said housing, said fluid container defining a medicine-filled reservoir and including a movable piston at a proximal end of said reservoir;

a needle assembly removably attached to a distal end of said fluid container to have an injection needle of said needle assembly in flow communication with said reservoir;

a drive member advanceable within said housing in a distal direction to move said piston toward said injection needle for forcing medicine from said container;

a dose setting element including a control portion external to said housing and manually rotatable in a first direction to screw said dose setting element from a plunged position to a plungeable position at which said dose setting element projects farther proximally from said housing than at said plunged position;

means, operable by translating without rotation said dose setting element from said plungeable position to said plunged position, for advancing said drive member in said distal direction, said advancing means comprising a drive sleeve and a barrel within said housing that experience relative rotation during at least a portion of a movement of said dose setting element between said plunged position and said plungeable position; and

an electronics assembly that displays a dose of medicine to be injected based on a sensing of the relative rotational positions of said barrel and said drive sleeve.

45. The medication injector apparatus of claim 44 wherein said barrel and said drive sleeve translate distally without rotation within said housing from a first axial position to a second axial position when said dose setting element translates without rotation during a segment of its travel from said plungeable position to said plunged position, and wherein said electronics assembly includes a switch that is activated when said barrel and said drive sleeve travel from said first axial position to said second axial position to signal a transition of the apparatus from a dosing mode to an injecting mode.

46. The medication injector apparatus of claim 45 wherein said travel segment of said dose setting element starts at said plungeable position.

47. The medication injector apparatus of claim 45 wherein said drive sleeve is moved from said first axial position toward said second axial position by direct engagement with said dose setting element, wherein said drive sleeve includes an abutment surface, and wherein said barrel includes a surface directly contacted by said drive sleeve abutment surface for moving said barrel from said first axial position toward said second axial position.

48. The medication injector apparatus of claim 47 wherein said barrel surface directly contacted by said drive sleeve abutment surface comprises a proximal face of a radially inwardly protruding lip of said barrel, wherein a distal face of said lip includes a plurality of splines that engage a splined bulkhead of said housing to prevent barrel rotation when said barrel is disposed in said second axial position.

49. The medication injector apparatus of claim 45 wherein said switch is mounted on a slider element keyed with said barrel to be axially fixed and rotatably movable relative thereto.

50. The medication injector apparatus of claim 49 wherein said slider element includes at least one radially inwardly protruding key that slides within at least one circumferential groove formed in an exterior surface of said barrel.

51. The medication injector apparatus of claim 50 wherein said slider element is keyed with said housing to be rotatably fixed and axially movable relative thereto, and wherein said switch is activated by being closed to complete an electrical circuit by a biasing engagement with a feature of said housing.

52. The medication injector apparatus of claim 44 wherein said advancing means automatically resets said dose setting element for a subsequent dosing when said dose setting element translates without rotation from said plungeable position to said plunged position.

53. The medication injector apparatus of claim 44 wherein said dose setting element is keyed with said barrel within said housing to be axially movable and rotatably fixed relative to said barrel, and wherein said dose setting element includes a threading radially inwardly projecting from an interior surface that engages a threading of said drive sleeve.

54. The medication injector apparatus of claim 53 wherein said barrel and said drive sleeve translate distally without rotation within said housing from a first axial position to a second axial position when said dose setting element translates without rotation during a segment of its travel from said plungeable position to said plunged position, and further comprising means for preventing rotation of said barrel relative to said housing and halting further distal axial motion of said drive sleeve when said barrel and drive sleeve are disposed in said second axial position, whereby axial travel of said dose setting element after said travel segment and toward said plunged position rotates said drive sleeve.

55. The medication injector apparatus of claim 53 wherein said threading of said drive sleeve comprises a slot helically extending around an exterior periphery.

56. A medication injector apparatus comprising:

a housing;

a medicine-filled container mounted to said housing and including a movable piston at one end and an outlet at the other end;

a drive member advanceable within said housing in a distal direction to move said piston toward said outlet for forcing medicine from said container;

a drive sleeve around and operatively connected to said drive member, said drive sleeve rotatable to advance said drive member distally;

a barrel around said drive sleeve and movable in said distal direction within said housing by engagement with said drive sleeve from a first axial position to a second axial position, said barrel being freely rotatable relative to said housing at said first axial position and rotatably fixed relative to said housing at said second axial position;

a dose setting element including a manually rotatable portion external to said housing, said dose setting element keyed with said barrel within said housing to be axially movable and rotatably fixed relative to said barrel, said dose setting element in threaded engagement with said drive sleeve;

said manually rotatable portion being rotatable in a first direction such that said dose setting element rotates and moves proximally along said drive sleeve due to the threaded engagement therebetween, whereby said dose setting element moves from a plunged position to a plungeable position at which said dose setting element projects farther proximally from said housing than at said plunged position; and

whereby when said dose setting element is in said plungeable position, application of a force in a distal direction on said dose setting element first translates distally and without rotation said dose setting element and said drive sleeve and said barrel relative to said housing until said barrel shifts from said first axial position to said second axial position, and then, until said dose setting element reaches said plunged position, translates distally and without rotation said dose setting element relative to said housing while thereby rotating without translation said drive sleeve to advance said drive member distally within said housing.

57. The medication injector apparatus of claim 56 wherein said drive sleeve includes an abutment surface, and said barrel includes a surface directly contacted by said drive sleeve abutment surface for moving said barrel from said first axial position toward said second axial position during shifting of said drive sleeve distally within said housing.

58. The medication injector apparatus of claim 56 wherein said barrel surface directly contacted by said drive sleeve abutment surface comprises a proximal face of a radially inwardly protruding lip of said barrel, wherein a distal face of said lip includes a plurality of splines that engage a splined bulkhead of said housing to prevent barrel rotation when said barrel is disposed in said second axial position.

59. The medication injector apparatus of claim 56 wherein said threaded engagement between said dose setting element and said drive sleeve comprises a thread radially inwardly projecting from an interior surface of said dial and which slides along a slot helically extending around an exterior periphery of said drive sleeve.

60. The medication injector apparatus of claim 56 further comprising a biasing member resisting movement of said barrel from said first axial position to said second axial position.

61. The medication injector apparatus of claim 56 further comprising an electronics assembly that displays a dose of medicine to be injected based on a sensing of the relative rotational positions of said barrel and said drive sleeve both during the rotation of said dose setting element which moves said dose setting element from said plunged position to said plungeable position, and during the translation of said dose setting element from said plungeable position to said plunged position.