Drug Delivery Device

• US 20100022992A1
• Filed: 05/06/2007
• Published: 01/28/2010
• Est. Priority Date: 05/07/2006
• Status: Active Grant

• Current Assignee: United Therapeutics Corporation
• Original Assignee: SteadyMed Ltd. (United Therapeutics Corporation)
• Inventors: Aldar, Yossi, Bachar, Yehuda, Aurbach, Doron, Goldstein, Jonothan, Levi, Mikhail, Markevich, Elena, Salitra, Grigory, Fleischer, Niles, Genosar, Amir
• Granted Patent: US 8,834,454 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• 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 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: H01M 10/02 Details of electrodes H01M4/00; of non-active parts H01M50/00
• CPC Class Codes: H01M 10/05 Accumulators with non-aqueous electrolyte H01M10/39 takes precedence
• CPC Class Codes: H01M 10/42 Methods or arrangements for servicing or maintenance of secondary cells or secondary half-cells H01M10/60 takes precedence
• CPC Class Codes: H01M 2220/30 Batteries in portable systems, e.g. mobile phone, laptop
• CPC Class Codes: H01M 50/10 Primary casings; Jackets or wrappings
• CPC Class Codes: H01M 50/102 characterised by their shape or physical structure
• CPC Class Codes: Y02E 60/10 : Energy storage using batteries

Abstract

The present application provides a drug-delivery device comprising a drug reservoir chamber 16, containing a substance to be delivered, in fluid connection with a drug administration means 18, and an electrically-controlled battery unit 10 comprising at least one displacement-generating battery cell 19 coupled to the drug reservoir chamber 16 by a coupling means 14, the arrangement being such that the displacement derived from the battery unit 10 is conveyed by the coupling means 14 to the drug reservoir chamber 16 such that the substance is expelled from the drug reservoir chamber 16 towards the drug administration means 18.

Claims

1. A drug-delivery device comprising a drug reservoir chamber, containing a substance to be delivered, in fluid connection with a drug administration means, and an electrically-controlled battery unit comprising at least one displacement-generating battery cell coupled to said drug reservoir chamber by a coupling means, the arrangement being such that the displacement derived from said battery unit is conveyed by said coupling means to said drug reservoir chamber such that said substance is expelled from said drug reservoir chamber towards said drug administration means.

2. A drug-delivery device according to claim 1 wherein said drug administration means is selected from the group consisting of cannulas, cannula arrays, needle, micro-needle arrays, exit ports and transdermal patches.

3. A drug-delivery device according to claim 1 wherein each of said at least one displacement-generating battery cells comprises at least one volume-changing element.

4. A drug-delivery device according to claim 1 wherein the volume of each of said at least one displacement-generating battery cells is changed as its respective electrical capacity is changed.

5. A drug-delivery device according to claim 3 wherein each of said at least one displacement-generating battery cells employs a chemical reaction system based on electrochemical insertion of metal ions.

6. A drug-delivery device according to claim 5 wherein each of said at least one displacement-generating battery cells employs a chemical reaction system chosen from the group including Li—

Sn, (Li)LiC₆—

Sn, Fe—

LaNis, lithium-lead, lithium-antimony, lithium-silicon and lithium-bismuth.

7. A drug-delivery device according to claim 1 wherein said battery unit serves to power at least some of the electrical and electronic elements of said device.

8. A drug-delivery device according to claim 1 where said coupling means is mechanical.

9. A drug-delivery device according to claim 8 where said coupling means involves a displaceable wall applying direct displacement from said battery unit to said drug chamber.

10. A drug delivery device according to claim 9 where said coupling means is a common wall of the battery cell and the drug reservoir.

11. A drug-delivery device according to claim 8 where said coupling means involves a displaceable wall applying indirect displacement from said battery unit to said drug chamber.

12. A drug-delivery device according to claim 1 where said coupling means is hydraulic.

13. A drug-delivery device according to claim 1 wherein said drug-delivery device is disposable.

14. A drug-delivery device according to claim 1 wherein some parts of the said drug-delivery device are disposable.

15. A drug-delivery device according to claim 1 wherein said drug-delivery device is an implantable device.

16. A drug-delivery device according to claim 1 wherein said drug-delivery device further comprises a filling means.

17. A drug-delivery device according to claim 1 wherein said drug-delivery device further comprises a battery recharging means.

18. A drug-delivery device according to claim 1 wherein said drug-delivery device is a multiple-use device-.

19. A drug-delivery device according to claim 1 wherein said drug-delivery device is a patch-type pump.

20. A drug-delivery device according to claim 19 wherein said patch-type pump is attached to the body of a user by a means comprising an adhesion means, a strap, a clasp and combinations thereof.

21. A drug-delivery device according to claim 1 wherein said drug-delivery device further comprises auto-insertion means of the administration means.

22. A drug-delivery device according to claim 21 wherein said auto-insertion means serves to insert the administration means.

23. A drug-delivery device according to claim 21 wherein said auto-insertion means automatically activates the drug-delivery device.

24. A drug-delivery device according to claim 1 wherein said drug-delivery mechanism further comprises a plurality of drug chambers containing different drug components.

25. A drug-delivery device according to claim 24 wherein said drug-delivery device includes means for the mixing of said different drug components from said plurality of drug chambers.

26. A drug-delivery device according to claim 1 wherein said drug-delivery device further comprises a plurality of battery cells.

27. A drug-delivery device according to claim 15 wherein said drug chamber includes means enabling the intake of body fluids;

said fluids serving to dilute a drug for subsequent administration by said drug-delivery device on reversion to its normal operating mode.

28. A drug-delivery device according to claim 27 wherein said device further comprises means for sampling body fluids for analysis.

29. A drug-delivery device according to claim 1 wherein said drug-delivery device further comprises communications means to remote devices, said communications means being selected from the group consisting of magnetic induction, infra-red, and RF devices.

30. A drug-delivery device according to claim 2 wherein said administration means further comprises a safety feature to protect against accidental contact or injury.

31. A drug-delivery device according to claim 1, wherein said drug reservoir chamber is coupled to said battery unit via a displaceable wall;

such that the volume change from said battery unit serves to control the rate of delivery of the drug.

32. A drug-delivery device according to claim 1, wherein said drug reservoir chamber is coupled to said battery via a piston arrangement;

such that the volume change from said battery cell serves to control the rate of delivery of the drug.

33. A drug-delivery device according to claim 1 wherein said battery cell is a lithium-tin battery cell where the volume change in the tin electrode on discharge of said cell causes the direct displacement of a displaceable wall of the drug chamber.

34. A drug delivery device according to claim 1 where the pressure in the drug chamber is monitored as part of the control and safety logic of the system.

35. A drug delivery device according to claim 1 wherein said device is selected from the group consisting of implantable devices, slow-infusion devices, disposable infusion devices, partially-disposable infusion devices and patchpumps attached to the skin.

36. A drug delivery device according to claim 1 wherein said displacement generating battery is a primary cell.

37. A drug delivery device according to claim 1 wherein said displacement generating battery is a secondary cell.

38. A drug delivery device according to claim 1 wherein at least one component of the battery unit undergoes a volume change of at least 200/0.

39. A drug delivery device according to claim 1 wherein at least one component of the battery unit undergoes a volume change of at least 30%.

40. A drug delivery device according to claim 1 wherein said drug chamber is provided with a rigid displaceable wall section.

41. A drug delivery device according to claim 1 wherein said drug chamber is provided with a flexible displaceable wall section.

42. A drug delivery device according to claim 1 wherein the displacement derived from said battery unit exerts a force of at least 1 kg/sq.

43. A drug delivery device according to claim 1 wherein the displacement derived from said battery unit exerts a force of at least 10 kg/sq.

44. A displacement-generating battery cell for driving a drug-delivery device and comprising at least one volume-changing element, said cell comprising a housing formed according to a concertina-shaped design with folds in the walls thereof and containing an internal chemical reaction system, the arrangement of said chemical reaction system being such that as the cell is discharged, said volume-changing element expands, thereby lengthening the battery and thus reducing the extent of said folds, such that the cell becomes taller to reflect the expansion of said volume-changing component.