DRUG DELIVERY DEVICE WITH A MODULE FOR PREVENTING FIBRILLATION DOWNSTREAM OF ITS RESERVOIR

• US 20110144585A1
• Filed: 07/20/2009
• Published: 06/16/2011
• Est. Priority Date: 08/25/2008
• Status: Active Grant

• Current Assignee: Debiotech S.A.
• Original Assignee: Debiotech S.A.
• Inventors: Conan, Christophe, Bianchi, Francois
• Granted Patent: US 8,257,308 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• CPC Class Codes: A61M 2205/7527 liquophilic, hydrophilic
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters

Abstract

The invention relates to a drug delivery device (1, 100), in particular for the delivery of drugs comprising molecules tending to spontaneously form nucleation seeds leading to fibrils, comprising a drug reservoir (2, 102) having a reservoir outlet (107) connected to a device outlet, adapted to deliver a drug fluid to a patient'"'"'s body, through a pathway (5) including a fluid flow controlling system (4, 104). The pathway further includes a filtration module (6, 106) adapted to retain the nucleation seeds, preferably by forcing them through a filtering membrane pores and on the basis of hydrophobic interaction with the membrane.

Claims

1. Drug delivery device (1, 100), in particular for the delivery of drugs comprising molecules tending to spontaneously form nucleation seeds leading to fibrils or aggregates, comprising a drug reservoir (2, 102) having a reservoir outlet (107) connected to a device outlet, adapted to deliver a drug fluid to a patient'"'"'s body, through a pathway (5) including a fluid flow controlling system (4, 104), characterised in that said pathway further includes a filtration module (6, 106) comprising a porous membrane adapted to absorb nucleation seeds.

2. Drug delivery device (1,100) according to claim 1 wherein said seeds are insulin seeds.

3. Drug delivery device 1,100) according to claim 1 wherein said membrane is also adapted to prevent air bubble transport across it.

4. Drug delivery device 1,100) according to claim 1 wherein said membrane is also adapted to prevents particles to be transported across it.

5. Drug delivery device 1,100) according to claim 4 wherein said particles have a diameter size which is above 0.45 microns.

6. Device according to claim 1, characterised in that said filtration module (6, 106) is arranged at said reservoir outlet (107).

7. Device according to claim 1, characterised in that said porous membrane has a mean pore size that is approximately X times the mean diameter of said nucleation seeds, where X is equal to 0.9, or smaller, in order to retain said nucleation seeds essentially by size screening.

8. Device according to claim 7, characterised in that said porous membrane has a mean pore size that is substantially in the range between 4 and 25 nm.

9. Device according to claim 1 which is adapted for delivery of insulin or any other drug having similar physicochemical properties, characterised in that said porous membrane exhibits hydrophilic surface properties.

10. Device according to claim 1, characterised in that said porous membrane has a mean pore size that is approximately X times the mean diameter of said nucleus seeds, where X is equal to 2, or larger, in order to retain said nucleation seeds essentially by adsorption on the surface of the pores.

11. Device according to claim 10, characterised in that said porous membrane has a mean pore size that is substantially in the range between 50 and 1000 nm.

12. Device according to claim 10, particularly suitable for delivery of insulin or any other drug having similar physicochemical properties, characterised in that said porous membrane exhibits hydrophobic surface properties.

13. Device according to claim 12, characterised in that said porous membrane further exhibits hydrophilic surface properties, preferably at its external surface arranged on the reservoir side while said hydrophobic surface properties are provided within said porous membrane.

14. Device according to claim 1, characterised in that said porous membrane is made of a material taken from the group comprising:

Polypropylene (PP), Polystyrene (PS), High impact polystyrene (HIPS), Acrylonitrile butadiene styrene (ABS), Polyethylene terephthalate (PET), Polyester (PES), Polyamides (PA) (Nylons), Poly(vinyl chloride) (PVC), Polyurethanes (PU), Polycarbonate (PC), Polyvinylidene chloride (PVDC), Polyethylene (PE), Polycarbonate/Acrylonitrile Butadiene Styrene (PC/ABS), Polymethyl methacrylate (PMMA), Polytetrafluoroethylene (PTFE), Polyetheretherketone (PEEK), Polyetherimide (PEI), Phenolics (PF), Urea-formaldehyde (UF), Melamine formaldehyde (MF), Polylactic acid and Plastarch material.

15. Device according to claim 1, characterised in that it exhibits a porosity in the range between 5 and 50%.

16. Device according to claim 15, characterised in that said porous membrane has a thickness in the range between 5 and 1000 μ

m.

17. Device according to claim 1, characterised in that said porous membrane has an effective surface oriented transversely in said pathway and the area of which is in the range approximately between 0.25 and 5 cm².

18. Device according to claim 1, characterised in that said porous membrane has a disc shape and is arranged before said pathway at the reservoir outlet (107).

19. Device according to claim 1, characterised in that said filtration module is further suitable for retaining gas bubbles.