Processes for delivery of viscous drug therapies

Patent metadata

Field	Value
Publication number	US-10493205-B2
Application number	US-201715652214-A
Country	US
Kind code	B2
Filing date	Jul 17, 2017
Priority date	Nov 7, 2011
Publication date	Dec 3, 2019
Grant date	Dec 3, 2019

Abstract

Core annular flow is used to enable the subcutaneous delivery of a viscous fluid such as a protein therapeutic formulation. The high-viscosity fluid is surrounded by a low-viscosity fluid, and the low-viscosity fluid lubricates the passage of the high-viscosity fluid. This allows the use of protein formulations that have a higher concentration and a higher viscosity at comparatively reduced injection forces and reduced injection times. Several different embodiments of injection devices that provide core annular flow are described herein.

First claim

The invention claimed is:

1. An injection device for creating core annular flow, comprising:
a barrel having an interior space formed from a sidewall, an open end having an orifice, and an inner concentric wall within the sidewall, wherein the inner concentric wall divides the interior space into an inner compartment and an outer compartment;
a flow diverter located between the inner compartment and the orifice; and a plunger operating within the barrel;
wherein the flow diverter is adapted so that depressing the plunger causes fluid in the inner compartment to form an annulus and causes fluid in the outer compartment to flow as a core surrounded by the annulus.

2. The injection device of claim 1 , wherein the flow diverter is formed from a flow cap and a flow base;
wherein a center of the flow cap connects to the inner concentric wall, and at least one radial spoke extends from the center of the flow cap to an annular ring, an underside of the annular ring including a circumferential groove, the circumferential groove creating an inner ring wall and an outer ring wall;
wherein the flow base includes a central surface with at least one radial spoke extending from the central surface to an annular wall;
wherein the at least one radial spoke of the flow cap and the at least one radial spoke of the flow base cooperate to form a tunnel that channels fluid from the inner compartment to the circumferential groove.

3. The injection device of claim 2 , wherein the central surface of the flow base has a diameter equal to an outer diameter of the inner concentric wall.

4. The injection device of claim 2 , wherein the annular wall of the flow base has an outer diameter equal to the outer diameter of the inner ring wall of the flow cap.

5. The injection device of claim 2 , wherein the inner concentric wall and the flow cap are formed as one integral component.

6. The injection device of claim 2 , wherein the flow cap includes throughbores between the inner concentric wall and the inner ring wall; and wherein the flow base includes throughbores between the central surface and the annular wall.

7. The injection device of claim 2 , wherein the flow cap rests upon a horizontal stop surface within a needle hub, and the flow base is seated within the needle hub.

8. The injection device of claim 2 , wherein the plunger comprises a central piston located within the inner compartment and a ring piston located within the outer compartment, the central piston and the ring piston being connected to a common shaft.

9. An injection device for delivering a high-viscosity fluid, comprising:
a barrel having an orifice, an interior space that is separated into a first compartment and a second compartment, and at least one channel connecting the second compartment to the first compartment, the channel being shaped so that a low-viscosity fluid flows from the second compartment circumferentially against a sidewall of the first compartment to create core annular flow;
wherein the first compartment contains the high-viscosity fluid;
wherein the second compartment contains a low-viscosity fluid; and
a plunger operating within the barrel.

10. The injection device of claim 9 , wherein the barrel is an outer barrel containing the first compartment, and further comprising an inner barrel that slides within the outer barrel, the inner barrel containing the second compartment.

Assignees

• Battelle Memorial Institute

Inventors

• Scribben Eric C
• Risser Steven M
• Heintz Amy M
• Ellis Jeffrey L
• Clay John D
• Blum Timothy M

Classifications

• A61M5/284

  comprising means for injection of two or more media, e.g. by mixing · CPC title

• A61M2005/247

  with fixed or steady piercing means, e.g. piercing under movement of ampoule · CPC title

• A61M2005/31598

  having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed · CPC title

• A61M2005/3128

  Incorporating one-way valves, e.g. pressure-relief or non-return valves · CPC title

• A61M5/204

  connected to external reservoirs for multiple refilling · CPC title