Medication delivery pen

• US 6,277,099 B1
• Filed: 08/06/1999
• Issued: 08/21/2001
• Est. Priority Date: 08/06/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Strowe, Robert J., Uschold, Robert C., Bendek, Antonio A., Burbank, John E. III, Packman, Jay D.
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/370,058
• Time in Patent Office: 746 Days
• Field of Search: 604/187, 604/200, 604/207, 604/208, 604/211, 604/218, 604/223, 604/228, 604/232, 604/234, 604/235, 604/244, 604/246, 604/131, 604/186, 604/152, 604/154
• US Class Current: 604/207
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3154 limiting maximum permissible dose
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/332 Force measuring means
• 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 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31556 Accuracy improving means
• 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 5/3158 performed by axially moving actuator operated by user, e.g. an injection button

Abstract

A medication delivery pen includes a housing having an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication, a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within the cartridge. A drive mechanism is coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication. The actuator triggers the drive mechanism to administer the injection of medication held in the cartridge and a processor is coupled to the actuator to determine a value equal to the dosage set by the actuator. The drive mechanism includes a pair of half nuts in rotational engagement with the actuator, a non-rotatable lead screw having a distal end for exerting the axial force on the piston to inject the set dosage of medication, a proximal end, and threads extending between the proximal and distal ends. The nuts open and close radially to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator.

Claims

1. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator; and

means for disabling the processor when the cartridge is removed or not properly inserted in the housing,

wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator.

2. The medication delivery pen of claim 1 further comprising a first spring located in the housing and biasing the lead screw in the distal direction so that the lead screw remains in contact with the piston of the cartridge when the cartridge assembly is attached to the housing.

3. The medication delivery pen of claim 1 wherein the actuator includes a rotatable knob and a plunger in rotational engagement with the rotatable knob, said plunger having a plurality of axial splines on its distal end that define slots therebetween, said housing having at least one radially extending boss that aligns with the slots in select rotational states of the plunger to allow axial motion of the plunger and misaligns with the slots in other rotational states of the plunger to prevent axial motion of the plunger, said select rotational states of the plunger corresponding to an integer number of dosage units.

4. The medication delivery pen of claim 1 further comprising a sensor arrangement coupled to the processor for detecting rotation of the actuator.

5. The medication delivery pen of claim 4 wherein the actuator includes a rotatable knob and a plunger in rotational engagement with the rotatable knob, said plunger having an axially intermediate portion over which a plurality of radially extending splines circumferentially surrounding the plunger and wherein the sensor arrangement measures a number of rotations traveled by the plunger by detecting the number of radially extending splines that traverse a given location and generating a signal corresponding thereto, said processor receiving the signal and determining a dosage that corresponds to the number of rotations traveled by the plunger.

6. The medication delivery pen of claim 1 wherein the actuator includes a rotatable knob and a plunger, said drive mechanism including a clutch for rotationally engaging the rotatable knob with the plunger unless a torque greater than a prescribed value is applied to the rotatable knob.

7. The medication delivery pen of claim 1 further comprising means for biasing the lead screw in the distal direction so that the lead screw remains in contact with the piston of the cartridge when the cartridge assembly is attached to the housing.

8. The medication delivery pen of claim 1 further comprising means for disabling the processor when the cartridge is removed or not properly inserted in the housing.

9. The medication delivery pen of claim 1 further comprising means for preventing delivery of non-integer dosage units of medication.

10. The medication delivery pen of claim 9 wherein said delivery prevention means includes a portion of the housing that prevents axial motion of the actuator when the actuator is in select rotational states.

11. The medication delivery pen of claim 1 further comprising means for detecting rotation of the actuator and determining a dosage of medication corresponding thereto.

12. The medication delivery pen of claim 1 further comprising a display disposed on the housing for displaying at least the dosage value determined by the processor.

13. The medication delivery pen of claim 1 further comprising a memory device coupled to the processor to store at least the dosage value determined by the processor.

14. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator, wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator; and

a release nut engaging with the lead screw at a location distally of the half nuts, said release nut being located at a first axial position when the cartridge is attached to the housing, and a second axial position when the cartridge is removed from the housing, said release nut activating the processor so that the processor is in an operational state when the release nut is in the first axial position and is in a disabled state when the release nut is in the second axial position.

15. The medication delivery pen of claim 14 wherein said release nut includes at least one tab that engages with the housing and the lead screw to prevent rotation of the lead screw.

16. The medication delivery pen of claim 14 wherein each of the half nuts have a radially extending boss engaging with an axial slot located on the distal end of the actuator, said radially extending bosses contacting an inner bearing surface of the housing when the release nut is in the second axial position to prevent further axial travel of the half nuts and so that the half nuts radially open to release the lead screw.

17. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator, wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator;

a release nut engaging with the lead screw at a location distally of the half nuts and

at least one dial stop element coupling the distal ends of the half nuts to the release nut so that the axial travel of the half nuts is limited to a minimum value, thereby limiting the injectable dosage of medication to a minimum value.

18. The medication delivery pen of claim 17 wherein said at least one dial stop element further limits the axial travel of the half nuts to a maximum value, thereby limiting the injectable dosage of medication to a maximum value.

19. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator, wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator; and

a radially biased eject button for locking the actuator into a depressed state after medication is injected,

wherein said radially biased eject button has an inner cylindrical surface in which at least a portion of the actuator is situated, said actuator portion having a generally cylindrical shape with its distal end having a first diameter and its proximal end having a second diameter that is less than the first diameter such that the eject button is radially movable when its inner surface contacts the proximal end of the actuator portion, said actuator portion being in an extended state to trigger the drive mechanism to inject the medication and in said depressed state after the medication is injected, said distal end of the actuator portion being located in the eject button when the eject button is in its extended state so that the actuator portion cannot undergo a substantial degree of radial travel, and said proximal end of the actuator portion being located in the eject button when the eject button is in its depressed state, whereby in its depressed state the actuator portion is axially locked in position by a radial force arising from a radial displacement of the radially biased eject button.

20. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator, wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator; and

a sensor arrangement coupled to the processor for detecting rotation of the actuator, said sensor arrangement including at least one piezoelectric film that undergoes deformation and generates an electric signal in response thereto when the actuator is rotated.

21. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator, wherein the drive mechanism includes;

a pair of half nuts in rotational engagement with the actuator;

a non-rotatable lead screw having a proximal end, a distal end for exerting the axial force on the piston to inject the set dosage of medication, and a set of threads extending between the proximal and distal ends, said half nuts being radially openable and closable to selectively engage with the threads of the lead screw for axially advancing along the lead screw upon rotation of the actuator; and

a sensor arrangement coupled to the processor for detecting rotation of the actuator, said sensor arrangement further includes a flexible planar material having a first and second opposing surfaces, a pawl extending from said first surface, and first and second piezoelectric films disposed adjacent to said second surface of the flexible planar material such that when one of the radially extending splines traverses said given location engages said pawl, said pawl deforms the flexible planar material, which in turn deforms the first and second piezoelectric films.

22. The medication delivery pen of claim 21 wherein said first and second piezoelectric films are situated with respect to said pawl such that upon deformation of the flexible planar material by the engagement between said pawl and one of the radially extending splines said first and second piezoelectric films undergo deformation with opposite curvatures.

23. A medication delivery pen, comprising:

a housing having opposing proximal and distal ends;

an actuator disposed in the proximal end of the housing for setting and administering a dosage of medication;

a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding, fluid tight engagement within said cartridge;

a drive mechanism coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication, wherein the actuator triggers the drive mechanism to administer the injection of medication held in the cartridge;

a processor coupled to the actuator to determine a value equal to the dosage set by the actuator; and

a sensor arrangement coupled to the processor for detecting rotation of the actuator, said sensor arrangement including at least one piezoelectric film that undergoes deformation and generates an electric signal in response thereto when the actuator is rotated.