Delivery device

• US 20060069382A1
• Filed: 10/05/2005
• Published: 03/30/2006
• Est. Priority Date: 04/11/2003
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Pedersen, Per Elgaard
• Application Number:
  US11/243,773
• Publication Number:
  US 20060069382A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

This invention relates to a delivery device of the bleeding hole type, where a primary drive fluid, e.g. silicon oil, is used to expel a secondary fluid, e.g. a drug, contained in a reservoir. To provide a desired drug flow rate, the primary fluid is forced from a first reservoir through a flow restrictor into a second reservoir displacing a portion of the drug reservoir, thereby expelling the drug from its reservoir. The idea is to provide a drive fluid outlet, i.e. a flow restrictor inlet, which protrudes into the first reservoir. By this arrangement the amount of particles and air-bubbles entering the narrow flow restrictor will be reduced. The reduction is achieved because particles and air-bubbles will normally concentrate in the top or bottom of the reservoir, whereas the protrusion will primarily connect to the centre of the first reservoir.

Claims

1. A delivery device (1, 600) comprising:

a housing,

a first variable volume cavity (31, 610) containing a drive fluid,

a flow restrictor (50, 52, 430, 620) comprising a flow channel,

a second variable volume cavity (19, 631) in fluid communication with the first variable volume cavity through the flow channel,

a variable volume drug reservoir (40, 640) having in a situation of use an outlet means,

the second variable volume cavity and the variable volume drug reservoir being arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases,

drive means (33, 601) for expelling the drive fluid from the first to the second cavity through the flow restrictor, whereby drug is expelled from the drug reservoir through the outlet means,

wherein the first variable volume cavity comprises an outlet portion (434, 651) with an outlet opening in fluid communication with the flow channel, the outlet portion protruding into the first variable volume cavity.

2. A delivery device as defined in claim 1, wherein the first variable volume cavity is defined by an interior wall surface, the outlet portion comprising an outlet opening arranged at a distance from the interior wall surface surrounding the outlet portion.

3. A delivery device as defined in claim 2, wherein the outlet portion (434, 651) has a generally tubular configuration with an outlet opening arranged at a distal end thereof.

4. A delivery device as defined in claim 2, wherein the outlet portion comprises a plurality of outlet openings, the most proximal thereof being arranged at a distance from the wall surface surrounding the outlet portion.

5. A delivery device as defined in claim 1, wherein venting means (440) is arranged between the first variable volume cavity and the flow restrictor.

6. A delivery device as defined in claim 5, wherein the venting means comprises means permeable to air but substantially impermeable to the drive fluid.

7. A delivery device (600) as defined in claim 1, further comprising

a fixed volume cavity (630) formed from a first material, the variable volume drug reservoir (640) being arranged there within and containing an initial amount of drug, the space between the drug reservoir and the fixed volume cavity forming the second variable volume cavity (631), the second variable volume cavity containing an initial amount of drive fluid,

a compensation component (632) made from a second material arranged within the second variable volume cavity, wherein

the volume of the compensation component is selected such that the combined thermal volume variation of the compensation component, the drive fluid and the drug contained within the fixed volume cavity essentially matches the thermal volume variation of the fixed volume cavity itself.

8. A delivery device (1, 500) as defined in claim 1, wherein the housing comprises a transparent portion allowing the content of the second variable volume cavity or the flow restrictor to be viewed from outside the device,

wherein the drive fluid is coloured for easy visual verification of its presence in the second variable volume cavity or the flow restrictor.

9. A delivery device as defined in claim 1, wherein the first variable volume cavity comprises:

a cavity member defining a cavity (331) and having a first opening (332) and a second opening (333),

a piston (311) having a distal end (312) facing towards the cavity, a proximal end (313) facing away from the cavity, a longitudinal axis and a circumferential outer surface portion (315), the cross-sectional area of the piston varying along the longitudinal axis thereof, the piston being received in the first opening and being moveable along the longitudinal axis,

a seal member (350, 550) arranged between the cavity member and the piston, the seal member being adapted to seal the gap therebetween when the piston is moved along its longitudinal axis,

whereby an area surrounded by the seal member corresponding to a cross-sectional area of the piston defines an effective piston area for transmitting a pressure to a fluid contained within the cavity.

10. A delivery device as defined in claim 1, wherein the flow restrictor (620, 701) comprises:

a first member (720) comprising a first surface portion and a second member (710) comprising a second surface portion,

an intermediate layer (730), having a thickness, arranged between the first and second members and comprising opposed first and second surfaces in engagement with the first respectively the second surface portions,

a trace (731) formed in the intermediate layer through the thickness thereof, whereby the flow channel is formed by the intermediate layer and the first and second surface portions in combination, and

inlet and outlet means in fluid communication with the flow channel thereby providing a fluid flow path therethrough.

11. A delivery device (600) comprising:

a housing,

a first variable volume cavity (610) containing a drive fluid,

a flow restrictor (620) comprising a flow channel,

a second variable volume cavity (631) in fluid communication with the first variable volume cavity through the flow channel,

a variable volume drug reservoir (640) having in a situation of use an outlet means,

the second variable volume cavity and the variable volume drug reservoir being arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases,

drive means (601) for expelling the drive fluid from the first to the second cavity through the flow restrictor, whereby drug is expelled from the drug reservoir through the outlet means,

wherein venting means (652) is arranged between the first variable volume cavity and the flow restrictor.

12. A delivery device (600) comprising:

a housing,

a first variable volume cavity (610) containing a drive fluid,

a flow restrictor (620) comprising a flow channel,

a second variable volume cavity (631) in fluid communication with the first variable volume cavity through the flow channel,

a variable volume drug reservoir (640) having in a situation of use an outlet means,

the second variable volume cavity and the variable volume drug reservoir being arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases,

drive means (601) for expelling the drive fluid from the first to the second cavity through the flow restrictor, whereby drug is expelled from the drug reservoir through the outlet means,

a fixed volume cavity (630) formed from a first material, the variable volume drug reservoir (640) being arranged there within and containing an initial amount of drug, the space between the drug reservoir and the fixed volume cavity forming the second variable volume cavity (631), the second variable volume cavity containing an initial amount of drive fluid,

a compensation component (632) made from a second material arranged within the second variable volume cavity, wherein

the volume of the compensation component is selected such that the combined thermal volume variation of the compensation component, the drive fluid and the drug contained within the fixed volume cavity essentially matches the thermal volume variation of the fixed volume cavity itself.

13. A delivery device (1, 600) comprising:

a housing,

a first variable volume cavity (31, 610) containing a drive fluid,

a flow restrictor (50, 52, 430, 620) comprising a flow channel,

a second variable volume cavity (19, 631) in fluid communication with the first variable volume cavity through the flow channel,

a variable volume drug reservoir (40, 640) having in a situation of use an outlet means,

the second variable volume cavity and the variable volume drug reservoir being arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases,

drive means (33, 601) for expelling the drive fluid from the first to the second cavity through the flow restrictor, whereby drug is expelled from the drug reservoir through the outlet means,

wherein the housing comprises a transparent portion allowing the content of the second variable volume cavity or the flow restrictor to be viewed from outside the device, the drive fluid being coloured for easy visual verification of its presence in the second variable volume cavity or the flow restrictor.

14. A reservoir comprising:

a cavity member defining a cavity (331) and having a first opening (332) and a second opening (333),

a piston (311) having a distal end (312) facing towards the cavity, a proximal end (313) facing away from the cavity, a longitudinal axis and a circumferential outer surface portion (315), the cross-sectional area of the piston varying along the longitudinal axis thereof, the piston being received in the first opening and being moveable along the longitudinal axis,

a seal member (350, 550) arranged between the cavity member and the piston, the seal member being adapted to seal the gap therebetween when the piston is moved along its longitudinal axis,

whereby an area surrounded by the seal member corresponding to a cross-sectional area of the piston defines an effective piston area for transmitting a pressure to a fluid contained within the cavity.