Subcutaneous drug delivery device with improved filling system

• US 6,186,982 B1
• Filed: 05/05/1998
• Issued: 02/13/2001
• Est. Priority Date: 05/05/1998
• Status: Active Grant

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Nitzan, Zvi, Cabiri, Oz, Tsals, Izrail, Razonowich, Mario, Danon, Haim, Lavi, Gilad, Gross, Joseph
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/072,875
• Time in Patent Office: 1,015 Days
• Field of Search: 604/19, 604/48, 604/23, 604/65, 604/890.1, 604/891.1, 604/140, 604/141, 604/93, 604/173-174, 604/180, 604/131-133
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir

Abstract

A subcutaneous drug delivery device having a housing having an internal reservoir in communication with a drug delivery needle via a fluid path. An expandable chamber disposed adjacent to the reservoir forces drug from the reservoir to the needle when supplied with a gas. A flow regulating chamber, in communication with the fluid path, is capable of volumetric changes in response to temperature and/or pressure changes. An increase in the volume of the flow regulating chamber increases flow resistance to the needle and thereby counteracts the corresponding increase in delivery rate resulting from the expansion of the expandable chamber due to the same volumetric changes in response to temperature and/or pressure.

The device also includes an improved filling system that enables the reservoir within the device to be filled with drug from a source without regard to filling position and with a decreased risk of injury from needles. Moreover, the filling system provides an accurate measure of drug transferred into the device thus enabling patients to fill the devices and to ensure proper dosage upon delivery.

Claims

1. A subcutaneous drug delivery device comprising:

a housing having an internal reservoir and an expandable chamber disposed relative to the reservoir,

a drug delivery needle extending from the housing for penetration of the skin of a subject, the needle having an outlet for drug delivery,

a fluid path defined between the delivery needle outlet and the reservoir,

means for providing a gas at a controllable rate into the expandable chamber,

and a flow regulating chamber, in communication with the fluid path, which is capable of volumetric changes in response to temperature and/or pressure changes.

2. A device according to claim 1, wherein the flow regulating chamber is associated with a blocking member which moves within the fluid path upon expansion of the flow regulating chamber so as to restrict the flow of drug.

3. A device according to claim 2, wherein the blocking member comprises a formation provided on a displaceable member which at least partially bounds the flow regulating chamber, the formation being disposed adjacent to an inlet of a conduit forming part of the fluid path, such that restriction of the fluid path occurs when the blocking member is moved into the inlet of the conduit.

4. A device according to claim 2, wherein the blocking member is adapted to cut off the fluid path completely with a predetermined degree of expansion of the flow regulating chamber.

5. A device according to claim 1, wherein the expandable chamber causes contraction of the reservoir in use.

6. A device according to claim 1, wherein the flow regulating chamber alters the drug delivery rate by varying the flow resistance between the reservoir and the outlet.

7. A device according to claim 1, wherein a displaceable cover is connected to the housing such that displacement of the housing relative to the cover when the cover has been applied to the skin of a subject causes the delivery needle to penetrate the skin of the subject.