Pen device for administration of parathyroid hormone

• US 20040097883A1
• Filed: 03/19/2003
• Published: 05/20/2004
• Est. Priority Date: 10/09/2000
• Status: Abandoned Application

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Roe, Michael Joseph
• Application Number:
  US10/381,097
• Publication Number:
  US 20040097883A1
• Time in Patent Office: Days
• US Class Current: 604/207
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile 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 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 5/31538 Permanent blocking, e.g. by medical personnel
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/3155 by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button

Abstract

A pen delivery device and a procedure for administering parathyroid hormone is provided to allow for the priming and injection of a single predetermined dose. The method is a three-step method using visual indicators to set the priming and injectable dose deliveries. The device is made of a minimal number of parts, which include a housing, a dose knob, a generally cylindrical disengaging assembly located within the proximal end of the dose knob, and an externally threaded drive stem. The pen device further includes a mechanism that prevents the user from dialing up a dosage greater than that remaining in the cartridge.

Claims

1. A pen delivery device (10) comprising;

a pen-shaped injector body (14, 20, 42) having proximal and distal ends and a reservoir (22) within the injector body;

a rotatable dose knob (11) attached to the proximal end of the injector body; and

a pen needle (23) removably attached to the distal end of the injector body;

characterized in that parathyroid hormone is contained within the reservoir;

said injector body has a first hard stop (44) to prevent dose delivery of more than a preset single maximum injectable dose of the parathyroid hormone; and

wherein the dose knob is marked with step designations (40) corresponding to a predetermined priming dosage and the preset single maximum injectable dose.

2. The pen delivery device (10) of claim 1 where the pen delivery device is disposable.

3. The pen delivery device (10) of claim 1 where the pen delivery device is reusable.

4. The pen delivery device (10) of claim 1 where the reservoir (22) is a glass cartridge.

5. The pen delivery device (10) of claim 4 where the cartridge (22) is removable from the injector body.

6. The pen delivery device (10) of claim 4 where the cartridge (22) is permanently affixed within the injector body.

7. The pen delivery device (10) of claim 1 where the dose knob (11) can be dialed in both a forward and reverse direction before dosing.

8. The pen delivery device (10) of claim 1 having a housing (14, 20) with threads (43) in communication with a dose knob (11), where said first hard stop (44) is positioned in the threads to limit rotation of the of the dose knob.

9. The pen delivery device (10) of claim 8 where the step designations (40) are the single priming position indicator and the single predetermined injectable dose position indicator on the dose knob (11).

10. The pen delivery device (10) of claim 1 where the injector body has a second hard stop (33, 35) to signal completion of the injection.

11. The pen delivery device (10) of claim 1 wherein the parathyroid hormone is human PTK (1-34).

13. A method of using a single dose pen delivery device (10) as claimed in any of claims 1-11 for the administering of parathyroid hormone to a patient.

12. A method of using a single done pen delivery device (10) for the administering of parathyroid hormone to a patient comprising,

providing a pen delivery device (10) containing a solution of parathyroid hormone and a pen needle (23),

rotating a dose knob (11) to a priming position indicator (40) located on the done knob (11);

pushing the dose knob (11) to prime the pen delivery device (10);

rotating the dose knob (11) to a hard stop position corresponding to an injectable dose indicator (40) located on the done knob (11);

inserting the pen needle (23) into the patient and injecting a predetermined injectable dose of the parathyroid hormone; and

removing the pen needle (23) from the patient after completing the injection.